Citeline Podcasts

PD-(L)1/VEGF双抗赛道——中国可否率先改写一线肺癌标准治疗？(Chinese-language podcast)

Fri, 24 Apr 2026 08:07:00 -0000

本期《中国生物技术播客》聚焦康方生物的依沃西单抗将如何改写历史，以及在PD-(L)1/VEGF双抗之间是否即将发生国内头对头三期临床试验。

Could PD-(L)1/VEGF Agents Face Off First In China Phase III Trials?

Scrip M&A Podcast with Cooley Attorneys Kevin Cooper and Bill Roegge.

Wed, 22 Apr 2026 15:52:00 -0000

Scrip Senior Writer Joseph Haas interviewed attorneys Kevin Cooper and Bill Roegge of Cooley LLP about recent events and trends in biopharmaceutical merger-and-acquisition activity. They discussed the current state of M&A after a busy conclusion to the first quarter and how that interplays with financing and partnering activity. In addition, Kevin offered tips for smaller companies to get good outcomes when dealing with large pharma firms, Bill talked about whether 2026 may be a year of competing bids in biopharma M&A and the discussion closed with a look at deals centered on platform technologies and their potential to replenish an acquirer's pipeline.

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast) Apr. 21, 2026

Tue, 21 Apr 2026 02:07:00 -0000

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年4月17日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。

本期要闻: Icotyde或将成为强生史上最重磅产品；daraxonrasib数据助力Revolution；Travere的Filspari成为首个用于治疗FSGS的药物；GSK重金押注B7-H4抗体药物偶联物；以及礼来夺得全球制药销售额榜首。

Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-KROBJCLAKVFBLCZ7BGBGCE3VDQ/

Scrip's Five Must-Know Things - Apr. 21, 2026

Tue, 21 Apr 2026 01:53:00 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended Apr. 17, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools.

This time – Icotyde could be J&J’s biggest ever product; daraxonrasib data boost Revolution; Travere’s Filspari becomes first drug for FSGS; GSK bets big on B7-H4 antibody-drug conjugate; and Lilly grabs top spot in global pharma sales.

Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-KROBJCLAKVFBLCZ7BGBGCE3VDQ/

The Generics Bulletin Podcast: Green Regulations With Medicines for Europe’s Adrian van den Hoven

Mon, 20 Apr 2026 16:04:00 -0000

Generics Bulletin senior reporter Urtė Fultinavičiūtė speaks to Medicines for Europe’s director general Adrian van den Hoven about pertinent environmental regulation changes in the region.

Drug Fix: CBER Director Candidate Emerges, US FDA Promotes Leucovorin Pathway

Fri, 17 Apr 2026 18:39:00 -0000

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter, Senior Reporter Maaisha Osman and Editor-in-Chief Nielsen Hobbs discuss potential takeaways from the Trump Administration floating ophthalmologist, entrepreneur and Fox News contributor Houman David Hemmati as the next potential Center for Biologics Evaluation and Research director (:34), as well as the appointment of US Food and Drug Administration Principal Deputy Commissioner Sara Brenner to a position in the Health and Human Services Department (8:30). They also consider whether the FDA’s approach to adding an indication for leucovorin could be more widely used in the rare disease space (14:08) and new guidance for the agency’s plausible mechanism pathway (22:50).

#pharma #business

More On These Topics From The Pink Sheet

New CBER Director Candidate Could Signal Industry Cred Important Again: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/new-cber-director-candidate-could-signal-industry-cred-important-again-ZDJ4ECR4QNDBPBRTKNHD2B5R24/

US FDA’s Principal Deputy Commissioner Moving To HHS As Senior Counselor For Public Health: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-principal-deputy-commissioner-moving-to-hhs-as-senior-counselor-for-public-health-C64ZB6WRTNEJ7MC7I3ZY3KNP6I/

US FDA’s Literature-Based Leucovorin Approval May Offer A Rare Disease Template: https://insights.citeline.com/pink-sheet/rare-diseases/us-fdas-literature-based-leucovorin-approval-may-offer-a-rare-disease-template-Z34IYMFF35ENVJXV4N4ZT4GG6Q/

US FDA To Clarify Plausible Mechanism Framework With Genome Editing Guidances, Workshop: https://insights.citeline.com/pink-sheet/advanced-technologies/cell-and-gene-therapies/us-fda-to-clarify-plausible-mechanism-framework-with-genome-editing-guidances-workshop-QTWKR3NCXJFJNKCOE3BTBSW4K4/

성숙기 진입 중인 ADC 시장…삼성바이오에피스, 차별화 전략 강화 (Korean-language podcast) Apr. 17, 2026

Fri, 17 Apr 2026 03:50:00 -0000

김윤철 삼성바이오에피스 상무는 Scrip과의 인터뷰에서 ADC 및 기타 신약개발 전략 등에 대해 이야기했습니다. 이 기사를 요약한 내용입니다.

(AI 기반 텍스트 음성 변환 및 음성 모방 도구의 도움을 받아 제작되었습니다)

Story link: https://insights.citeline.com/scrip/focus-on-asia/south-korea/samsung-bioepis-sharpens-differentiation-strategy-as-global-adc-market-matures-T4E7D2U4DZFJFIERGRWM7PECTM/

Japan Q1 Roundup: Key Commercial and Policy/Regulatory Developments

Fri, 17 Apr 2026 02:35:00 -0000

Join Scrip and The Pink Sheet's Tokyo-based team Lisa Takagi and Ian Haydock for a roundup of key commercial and policy/regulatory developments in Japan's biopharma market over the first few months of this year, including some important corporate divestments and new product approvals. Also a look at how the Iran war is impacting the healthcare sector in the country.

Lilly TuneLab: Breaking Data Silos in Biotech with Federated Learning

Mon, 13 Apr 2026 13:48:00 -0000

How can small biotechs tap billion‑dollar AI models without giving up their data? David Wild talks with Eli Lilly's Aliza Apple about Lilly TuneLab, a federated learning platform that lets companies use Lilly’s in-house drug discovery models while keeping their IP and datasets fully private. They dive into early use cases in ADMET and antibody developability, what early-stage users actually do in their first 90 days, and how shared models could reshape the economics of drug R&D.

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast) Apr. 10, 2026

Mon, 13 Apr 2026 03:14:00 -0000

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年4月10日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。

本期要闻: 特朗普政府对部分药品及原料药征收100%关税；美国关税政策给获美批准的中国药品带来阴影；吉利德收购Tubulis；深入解析Neurocrine对Soleno的收购要约；以及对第一季度并购活动的分析。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-O7KEIWGMHBCLZBHKJPKGHOZYPE/

Scrip's Five Must-Know Things - Apr. 13, 2026

Mon, 13 Apr 2026 02:46:00 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended Apr. 10, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools.

This time – Trump’s 100% tariffs and pharma; US tariffs loom over US-approved Chinese drugs; Gilead’s Tubulis buy-out; a closer look at Neurocrine’s Soleno bid; and an analysis of Q1 M&A.

Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-O7KEIWGMHBCLZBHKJPKGHOZYPE/

Drug Fix: Leucovorin’s Resurrection, PhRMA’s Leadership Change

Fri, 10 Apr 2026 15:54:00 -0000

Pink Sheet Executive Editor Derrick Gingery, Managing Editor Bridget Silverman and Editor-in-Chief Nielsen Hobbs discuss the details of the US Food and Drug Administration’s labeling update for leucovorin (:41), including GSK’s subsequent move to re-withdraw the application (19:45). They also grade the tenure of Steve Ubl as he prepares to leave as Pharmaceutical Research and Manufacturers of America president and CEO (21:02) and consider what the organization may seek in its next leader (27:07).

#pharma #business

More On These Topics From The Pink Sheet

A Regulatory Pathway Of One: US FDA’s Wellcovorin Approval Would Be Hard To Scale: https://insights.citeline.com/pink-sheet/rare-diseases/a-regulatory-pathway-of-one-us-fdas-wellcovorin-approval-would-be-hard-to-scale-BHEAMFMG5BDJHJY5K6Z5OJF22A/ Outgoing PhRMA CEO Ubl Fought, Shaped Policies and Politics Around Price Controls: https://insights.citeline.com/pink-sheet/r-and-d/breaking-phrma-ceo-steve-ubl-leaving-later-this-year-2FNX2D5LE5GC3J2HARTZPHZDB4/

No Matter What: How Israel Is Positioning Itself as a Global Pharma Innovation Hub

Wed, 08 Apr 2026 15:33:00 -0000

Israel has been a prolific source of biotech and AI-driven startups for years, but can it compete as a strategic R&D partner for global pharma? Mati Gill, CEO of AION Labs, makes the case that it can. AION's venture studio model brings together AstraZeneca, Merck KGaA, Pfizer and Teva under one roof to co-create AI-native drug discovery companies, and its portfolio is already producing results: CombinAbleAI, one of its startups, was acquired by insitro less than two years after it was founded. Gill talks about Israel's genuine strengths in science and technology, the structural gaps that still need closing, and why three years of operating through an active war may actually be a point in the ecosystem's favour for risk-conscious partners. Recorded, with some interruptions, from Tel Aviv.

Inside Step Pharma’s Pan‑Cancer Ambition

Tue, 07 Apr 2026 08:35:00 -0000

Andrew Parker, CEO at Step Pharma, outlined the company’s “pipeline in a product” strategy as it seeks to develop a targeted approach to blood cancers and solid tumors by inhibiting CTSP1 enzyme.

#clinicalstrategy #oncology

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast) Apr. 6, 2026

Mon, 06 Apr 2026 03:12:00 -0000

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年4月03日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。

本期要闻: 礼来收购Centessa的意义；Apellis为Biogen注入新能力；中国企业在肥胖症领域取得的快速进展；口服药物在肥胖症治疗中占据主导地位；以及全球制药研发管线规模的缩减。

Story link: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-HFN7H2ELQBBRHHFQQ2AYFBMXNM/

Scrip's Five Must-Know Things - Apr. 6, 2026

Mon, 06 Apr 2026 02:18:00 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended Apr. 3, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools.

This time – what Lilly’s Centessa buy brings; Apellis brings capabilities to Biogen: Chinese firms’ rapid obesity progress; orals take center stage in obesity; and a dip in the global pharma pipeline.

Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-HFN7H2ELQBBRHHFQQ2AYFBMXNM/

China Biopharma English-Language Podcast: China’s Regulatory Changes In Cell Therapy

Fri, 03 Apr 2026 07:00:00 -0000

In this episode of the China biopharma English-language podcast, Xu Hu talks about recently China releasing two guidelines related to CAR-T therapies within a month and the strategic position that the country puts its cell therapy sector.

The Pink Sheet stories related to this episode:

CAR-T Guidelines Signal China’s Next Phase Of Cell Therapy Regulatory System Building

CAR-Ts Win Big In New China Drug Coverage Lists

Five-Minute Podcast: “UK Needs To Align More With The EU”

Mon, 30 Mar 2026 12:03:00 -0000

A legal firm’s perspective on how the UK should evolve its medtech regulatory system, global harmonization and opportunities to embed best practice AI.

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast) Mar. 30, 2026

Mon, 30 Mar 2026 07:39:00 -0000

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年3月27当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。

本期要闻: 默克公司力推Terns及其他交易；勃林格殷格翰对欧洲创新环境不佳的警示；科伦与默克的协议如何改变了中国的交易格局；神经科学研发重振旗鼓；以及美国新的低密度脂蛋白胆固醇（LDL-C）指南与药物成本。

Why Longevity Is The Next Big OTC Opportunity, With Euromonitor’s Magda Starula

Mon, 30 Mar 2026 06:54:00 -0000

In this episode of HBW Insight’s Over the Counter, we’re digging into one of the most talked‑about themes in consumer health right now: longevity. We’re joined by Magda Starula, Health and Beauty Research Analyst at Euromonitor International, to unpack what “healthy longevity” really means, and why it’s quickly moving from niche concept to mainstream commercial opportunity for OTC. We explore how the focus is shifting from simply living longer to staying healthier for longer, what that means across different life stages, and where consumer healthcare brands are best placed to win.

Scrip's Five Must-Know Things - Mar.30, 2026

Mon, 30 Mar 2026 06:46:00 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended Mar.27, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – Merck’s case for Terns and more deals; Boehringer’s warning on innovation-unfriendly Europe; how Kelun-Merck pact changed China deal-making;

Story Link : https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-KYHAYYDQKVF2BPXKKKMZ2J4GA4/

Drug Fix: US FDA Commissioner Martin Makary Completes First Year In Charge

Fri, 27 Mar 2026 16:45:00 -0000

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider US Food and Drug Administration Commissioner Martin Makary’s first year in office, including the issues that shaped his tenure (:32), his biggest policy accomplishments (14:12), issues that could emerge in his second year (19:35), and when Makary’s term could end (22:52).

#pharma #business #FDA

More On These Topics From The Pink Sheet

US FDA Commissioner Makary’s ‘Bold’ Year 1 Reforms Clouded By Staff Churn, Process Issues: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-commissioner-makarys-bold-year-1-reforms-clouded-by-staff-churn-process-issues-BM6PHO3AWNBWXHL5UAJI4YE7TQ/

His Own Words: FDA Commissioner Martin Makary On His First Year Achievements And Challenges: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/his-own-words-fda-commissioner-martin-makary-on

US FDA Commissioner Martin Makary’s Eventful First Year: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-commissioner-martin-makarys-eventful-first-year-5KU6I3ATTBHIDKFLBKZDWJ5XHA/

Lupin’s CEO And MD On GLP-1 Strategy, Business Growth And Legacy

Thu, 26 Mar 2026 08:01:00 -0000

Lupin’s CEO Vinita Gupta and managing director Nilesh Gupta speak with Citeline’s senior editor Vibha Ravi about their plans for first-in-class and best-in-class assets including GLP-1 receptor agonists, the defining influence of their father D B Gupta on them, as well as the company’s ethos and future growth strategy.

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast) Mar.23, 2026

Mon, 23 Mar 2026 01:51:26 -0000

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年3月20日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。本期要闻: 今年将有众多重磅药物失去市场主导地位; 司美格鲁肽在印度的命运；跨国药企不再满足于单纯的中国授权； Almirall瞄准中国皮肤科资产；欧盟被敦促恢复生物制药竞争力。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-KZ6RVPJK6BAADJKFNBUNOTMB6M/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Scrip's Five Must-Know Things - Mar.23, 2026

Mon, 23 Mar 2026 01:18:42 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended Mar.13, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – many blockbusters to fade this year: semaglutide’s India reckoning; multinationals look beyond simple China licensing; Almirall eyes China dermatology assets; EU urged to restore biopharma competitiveness. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-KZ6RVPJK6BAADJKFNBUNOTMB6M/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Drug Fix: ACIP Next Steps After Judge Stops Work, Potential Opioid Disposal Changes

Fri, 20 Mar 2026 15:46:30 -0000

Pink Sheet Executive Editor Derrick Gingery, Managing Editor Bridget Silverman, and Editor-in-Chief Nielsen Hobbs discuss the next steps after a federal judge ruled the reconstitution of the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP), as well as recent changes to the childhood vaccine schedule, likely violated the law (:32). They also consider the responses to the decision from some controversial committee members (9:06) and prior ACIP priorities that now are delayed (14:50). More On These Topics From The Pink Sheet Federal Court Halts US CDC Vaccine Panel Appointments, Immunization Schedule Changes: https://insights.citeline.com/pink-sheet/vaccines/breaking-judge-stops-us-cdc-childhood-immunization-changes-acip-appointments-RBZR2RZY2BEU3IOXQT2MDBKKFM/ Fantasy Agenda: The ACIP Meeting That Could Have Been: https://insights.citeline.com/pink-sheet/vaccines/fantasy-agenda-the-acip-meeting-that-could-have-been-S4P2UO3G4FBOBAJGJUWRZ6IO6M/ Mail Not Enough? US FDA Considers New In-Home Opioid Disposal Requirements: https://insights.citeline.com/pink-sheet/product-reviews/post-marketing-regulation-and-studies/mail-not-enough-us-fda-considers-new-in-home-opioid-disposal-requirements-W3VJOHOHYZCMZK4THBCE2GKKCY/

How a CDMO Created a Custom Vaccine Development Project

Thu, 19 Mar 2026 13:19:41 -0000

What does it take to move from concept to commercial vaccine manufacturing at speed without compromising quality or compliance? In this conversation, leaders from Alfasigma’s CDMO arm, Morpho, share a detailed look at how they approached a complex vaccine technology transfer, from facility upgrades to regulatory approval. The discussion offers a grounded perspective on execution, coordination, and capability building in today’s evolving CDMO landscape. This podcast explores: • The role of facility design, sterile manufacturing, and cold chain expansion • Why flexibility in equipment and formats matters for biological products • Approaches to contamination control and aseptic processing • Coordinating engineering, quality, and regulatory teams under tight timelines • What this project reveals about broader CDMO trends, from personalization to speed and sustainability

뇌질환 신약 개발 펀딩 부활 조짐 (Korean-language podcast) Mar.19, 2026

Thu, 19 Mar 2026 01:38:56 -0000

최근 미국의 BIO 투자자 및 성장 서밋에서 투자자들은 초기 단계 신경과학 분야의 자금 조달 환경이 여전히 어렵지만, 이 분야에 대한 관심이 높아지고 있다는 징후가 보인다고 말했습니다. Scrip이 취재한 내용을 요약했습니다. AI 기반 텍스트 음성 변환 및 음성 모방 도구의 도움을 받아 제작되었습니다. Story link: https://insights.citeline.com/scrip/business/financing/neuroscience-drug-development-funding-poised-for-a-comeback-GEVK5NDEFRBSBKNEP67XY7QW6A/ Playlist: soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini

The Generics Bulletin Podcast: 2026 Conferences

Tue, 17 Mar 2026 15:56:00 -0000

The final week of February saw the AAM hold its Access! 2026 annual conference in Miami and Medicines for Europe hold its annual regulatory and scientific affairs conference in Amsterdam. Generics Bulletin was there at both events and our reporters discuss the key takeaways in our latest podcast.

Winning In The Probiotics Space, With David Pineda Ereño

Mon, 16 Mar 2026 08:45:23 -0000

Probiotics remain one of the fastest‑growing segments in consumer health, but companies still face the challenge of operating in a fragmented claims environment, building credible brands, and communicating benefits to increasingly savvy consumers. In part two of HBW Insight’s interview with probiotics expert, David Pineda Ereno, we explore how leading players are finding ways through this complexity: from launching strategically in more permissive markets like Italy and France, to using umbrella brands and authorised nutrient claims to support probiotic innovation. Finally, we turn to postbiotics, a newer but fast‑developing area that could open up additional commercial opportunities. With their stability and easier formulation, postbiotics are gaining traction — but they bring their own regulatory considerations too Guest Bio: David Pineda Ereño is managing director of DPE International Consulting, an international consultancy firm that provides strategic and regulatory advice on the policy, regulation and trade of foods and food supplements. David has over 20 years of experience providing strategic solutions to companies, trade associations, and government bodies at national, regional, and international level, in Europe, Latin America, Asia, Middle East and Africa, and the US.

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast) Mar.16, 2026

Mon, 16 Mar 2026 04:09:43 -0000

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年3月13日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。本期要闻: 罗氏的吉雷德斯特兰特（giredestrant）III期试验遭遇挫折；BioNTech创始人退出公司；伊普森将撤回Tazverik；拜耳面临困境；以及UCB的Bimzelx再获利好。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-LMR3CRGKRFDWLHTOSBRDCRM7GE/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Scrip's Five Must-Know Things - Mar.16, 2026

Mon, 16 Mar 2026 02:22:46 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended Mar.13, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – Roche faces giredestrant Phase III setback; founders exit BioNTech; Ipsen to withdraw Tazverik; tough times for Bayer; and another boost for UCB’s Bimzelx. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-LMR3CRGKRFDWLHTOSBRDCRM7GE/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Drug Fix: US FDA’s Prasad Leaves, Harry Potter, And Is CNPV Effective Because Of RTOR?

Fri, 13 Mar 2026 15:54:30 -0000

Pink Sheet Executive Editor Derrick Gingery, Managing Editor Bridget Silverman and Editor-in-Chief Nielsen Hobbs discuss potential directions for the US Food and Drug Administration’s Center for Biologics Evaluation and Research after the departure of Director Vinay Prasad (:32), including similarities between the center’s leadership issues and the staffing problems in the Harry Potter saga’s Hogwarts School of Witchcraft and Wizardry (7:48), as well as the potential policy implications (10:11). They also discuss the contributions of the agency’s Real-Time Oncology Review (RTOR) pilot program to the quick reviews of two Commissioner’s National Priority Voucher (CNPV) awardees (17:19). More On These Topics From The Pink Sheet US FDA’s Vinay Prasad, Controversial CBER Director, Leaving In April: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-vinay-prasad-controversial-cber-director-leaving-in-april-DJO7ACE73RCNTLZKQWCN2S26LM/ US FDA’s CNPV Approvals Ride RTOR Pilot’s Coattails: https://insights.citeline.com/pink-sheet/pathways-and-standards/review-pathways/us-fdas-cnpv-approvals-ride-rtor-pilots-coattails-3HEGU5MDWJEG7OYHSZQR6TE5NM/

Killing Cancer Loudly: Onchilles Pharma's Neutrophil-Derived Path to Pan-Cancer Therapy

Wed, 11 Mar 2026 20:37:04 -0000

What if a drug could kill cancer cells broadly, spare the immune system and then train it to keep fighting, without triggering resistance? That's the promise behind the ELANE pathway, a mechanism discovered not from a hypothesis but from studying fundamental biology in patients. In this episode of the In Vivo Podcast, Court Turner, CEO and co-founder of Onchilles Pharma, and Lev Becker, CSO and scientific founder, discuss how a neutrophil elastase-based mechanism is being translated into N17350, a first-in-class intratumoral agent targeting solid tumours including head and neck, skin and breast cancers. With $40m raised, GMP manufacturing of thousands of clinical doses completed, a US IND approved, and a first-in-human study underway in Australia, Onchilles is moving from "stubborn optimism" to clinical execution. Court and Lev discuss the dual mechanism that sets N17350 apart from both traditional chemotherapy and immunotherapy, why histone H1 functions as a universal tumour vulnerability rather than a conventional biomarker, and how they're thinking about combinations, partnering and the eventual value story for payers.

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast) Mar.9, 2026

Mon, 09 Mar 2026 02:23:13 -0000

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年3月6日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。本期要闻: 中小型企业考虑在最惠国待遇下拓展欧洲市场；辉瑞CEO谈FDA疫苗审批决策；人工智能时代大型药企对CRDMOs有何期待；神经科学研究资金蓄势复苏；优时比与中国达成重大合作。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-N3WEPHD34BHGBGRM5BNJPTS2NY/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Scrip's Five Must-Know Things - Mar.9, 2026

Mon, 09 Mar 2026 01:38:52 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended Mar.6, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – smaller companies consider European expansion under MFN; Pfizer CEO on FDA vaccine decisions; what does big pharma want from CRDMOs in AI age; neuroscience funding poised for comeback; and UCB’s big China deal. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-N3WEPHD34BHGBGRM5BNJPTS2NY/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Drug Fix: The State Of Facility Inspections With Two Former Senior US FDA Execs

Fri, 06 Mar 2026 15:23:07 -0000

Pink Sheet Executive Editor Derrick Gingery and Senior Editor Sue Sutter are joined by special guests Michael Rogers, former US Food and Drug Administration associate commissioner for inspections and investigations, and Douglas Stearn, former principal deputy associate commissioner in the FDA Office of Inspections and Investigations, both now at Canal Row Advisors. They talk about the current state of the agency inspection cadre and resource challenges (1:04) and offer thoughts on the FDA’s efforts to increase foreign inspections (25:24), as well as discuss the growing threat that receiving an Official Action Indicated (OAI) classification presents (35:20) and consider whether user fee goals eventually could be impacted (45:02). More On These Topics From The Pink Sheet US FDA Use of ‘Potential Official Action Indicated’ Flag Raises Concerns About Facility-Based CRLs: https://insights.citeline.com/pink-sheet/compliance/us-fda-use-of-potential-official-action-indicated-flag-raises-concerns-about-facility-based-crls-3JLUE3CW6BEIFOKQRZ5C4FKFOM/ US FDA’s Failure To Implement Key Workforce Reforms Puts Oversight At Risk, GAO Says: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-failure-to-implement-key-workforce-reforms-puts-oversight-at-risk-gao-says-B64V7RAIQNBNBI57ID5ZU3DYAE/ US FDA Remote Assessments Need Clearer Closeout Process, More Transparency, Experts Argue: https://insights.citeline.com/pink-sheet/compliance/manufacturing/us-fda-remote-assessments-need-clearer-closeout-process-more-transparency-experts-argue-4P5UQEPW7NDLNDDQERUQY5Y56M/

Unpacking Europe’s Probiotic Rules with David Pineda Ereño

Mon, 02 Mar 2026 07:20:32 -0000

The European market for probiotic dietary supplements is one of the most dynamic, but also one of the most complicated, areas of self‑care right now. Probiotics are hugely popular with consumers, widely used across Europe, and backed by an expanding body of science. But for companies trying to bring these products to market, one major obstacle remains: the European Union’s fragmented and highly restrictive regulatory environment. To help us unpack this, I’m joined on this episode of HBW Insight’s Over the Counter podcast by one of the leading experts on probiotics and the wider “biotics” category: David Pineda Ereño, managing director of DP International Consulting. In this first part of our conversation, we explore why the current international definition of “probiotic,” which currently includes the assertion that these microorganisms confer a health benefit on the host. It is this inbuilt health claim that has become such a regulatory sticking point in Europe. We discuss whether this definition could be revisited at the Codex Alimentarius level, and what that might mean for future harmonization. We also look at the growing divergence within the EU, as countries like Italy, Spain, Denmark and others move away from the European Commission’s restrictive position and allow the use of the term “probiotic” under certain conditions. Timestamps 2:00 – Introductions 4:30 – What are probiotics? 6:00 – Probiotic regulation in Europe 12:30 – Changing the definition 16:30 – The EFSA view 19:30 – EU member state divergence 22:15 – The Commission view 24:00 – What’s next? Guest Bio David Pineda Ereño is managing director of DPE International Consulting, an international consultancy firm that provides strategic and regulatory advice on the policy, regulation and trade of foods and food supplements. David has over 20 years of experience providing strategic solutions to companies, trade associations, and government bodies at national, regional, and international level, in Europe, Latin America, Asia, Middle East and Africa, and the United States.

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast) Mar. 2, 2026

Mon, 02 Mar 2026 07:08:31 -0000

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年3月2日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。本期要闻: Zealand首席执行官呼吁终结减肥竞赛；默沙东谈人工智能辅助研发管线；布鲁斯·莱文的CAR-T疗法故事；生物制药并购活动回暖；2025年美国IPO市场艰难。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-LTCVEH6JLFGRXBOQCFW6V72NVI/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Scrip's Five Must-Know Things - Mar.2, 2026

Mon, 02 Mar 2026 05:54:45 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended Feb.27, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – Zealand CEO calls for end to weight loss Olympics; MSD on AI-assisted pipelines; Bruce Levine’s CAR-T stories; biopharma dealmaking bounces back; and 2025 was a tough year for US IPOs. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-LTCVEH6JLFGRXBOQCFW6V72NVI/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Drug Fix: State Of The Generics Industry, US FDA Commissioner On Compassionate Use

Fri, 27 Feb 2026 16:26:58 -0000

Pink Sheet Executive Editor Derrick Gingery, Editor-in-Chief Nielsen Hobbs and special guest Dave Wallace, executive editor of Generics Bulletin, discuss the generic industry’s future direction and priorities (:27) and the impact of recent policy moves on the biosimilar industry (12:28) following their trade association’s annual meeting, as well as US Food and Drug Administration Commissioner Martin Makary’s comment on compassionate use and the concern it may have caused industry (20:23). More On These Topics From The Pink Sheet The State Of The Off-Patent Union: AAM’s Murphy Sets Out US Achievements And Obstacles: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/the-state-of-the-off-patent-union-aams-murphy-sets-out-achievements-and-obstacles-in-us-IHJH2CZBX5GGTI6UJQVE2WO2G4/ ‘Biology Is Dirty’: HHS’s Principal Deputy Counsel On How Biosimilar Firms Can Help US FDA: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/biosimilars/biology-is-dirty-hhss-principal-deputy-counsel-on-how-biosimilar-firms-can-help-us-fda-2GEAUSXNMRCYNIXPS7P6IAYESE/ Makary’s Compassionate Use Comments, Later Clarified, Still May Startle Industry: https://insights.citeline.com/pink-sheet/rare-diseases/makarys-compassionate-use-comments-later-clarified-still-may-startle-industry-XPBVZ6MH7FC7JKP2XEL4ZESWSE/

Affibody and the Case for Antibody Mimetics in Radioligand Therapy

Wed, 25 Feb 2026 19:03:35 -0000

Swedish biotech Affibody has spent over two decades engineering proteins 1/20th the size of a conventional monoclonal antibody — and CEO David Bejker believes they're perfectly suited to solve one of radioligand therapy's biggest problems: a dangerously narrow target space. Bejker discusses how Affibody's platform combines the selectivity of antibodies with the biodistribution flexibility of small molecules, the science behind its Albumod technology, and how its HER2 imaging and therapeutic programs are translating from animals to humans. He also digs into partnerships with AstraZeneca's respiratory unit and complement-focused Rally Bio, manufacturing advantages of E. coli-based production, and Affibody's long-term ambitions as a commercial-stage company.

글로벌 제약업계, 2026년 역풍 직면…최혜국 약가정책 영향은 제한적 (Korean-language podcast) Feb.25, 2026

Wed, 25 Feb 2026 00:34:57 -0000

특허 만료와 미국 내 약가 압박은 대형 글로벌 제약사들이 극복해야 할 과제이며, 다수 제약사가 올해 소폭의 실적 상승을 전망하고 있다는 Scrip 기사를 요약한 내용입니다. https://insights.citeline.com/scrip/drug-pricing/drug-makers-confront-headwinds-in-2026-but-mfn-doesnt-seem-like-a-big-one-YYQBO72NSNCHBE6EBPKF2GSDB4/ Playlist: soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast) Feb. 24, 2026

Tue, 24 Feb 2026 05:08:35 -0000

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年2月20日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。本期要闻: 哈德森在赛诺菲的遗产；特朗普推动美国制药投资背后的现实；拜耳的精准医疗战略与增长；今年值得关注的临床试验；以及Scrip关于人工智能与运营卓越的专题访谈。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-GO7ZGTBFEJDA5OUKAXHCTBVBDU/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Scrip's Five Must-Know Things - Feb.24, 2026

Tue, 24 Feb 2026 03:11:57 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended February 20, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – Hudson’s legacy at Sanofi; the realities behind Trump’s US pharma investment push; Bayer’s precision medicine approach and growth; clinical trials to look out for this year; and Scrip Asks on AI and operational excellence. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-GO7ZGTBFEJDA5OUKAXHCTBVBDU/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Drug Fix: ‘America First’ US FDA User Fees, Moderna’s Flu Vaccine Saga Continues

Fri, 20 Feb 2026 16:41:53 -0000

Pink Sheet Executive Editor Derrick Gingery, Managing Editor Bridget Silverman, Senior Editor Sue Sutter, and Editor-in-Chief Nielsen Hobbs discuss a series of US Food and Drug Administration proposals for user fee program changes that would advance President Trump’s priorities and the concerns they raise (:31). They also consider the impact of the agency’s decision to review Moderna’s mRNA flu vaccine application shortly after refusing to file it and using accelerated approval for one of the proposed indications (8:37), as well as ideas for sponsors wondering if their development advice is still good (25:24). More On These Topics From The Pink Sheet US FDA Proposing White House-Aligned Policies For User Fee Agreements: https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/us-fda-proposing-white-house-aligned-policies-for-user-fee-agreements-D5JWRDGLCFBT7CYT3FGK3JAZNI/ After Moderna Flu Vaccine, Is US FDA’s Accelerated Approval A Pathway Or A Pressure Valve?: https://insights.citeline.com/pink-sheet/pathways-and-standards/review-pathways/after-moderna-flu-vaccine-is-us-fdas-accelerated-approval-a-pathway-or-a-pressure-valve-EWMFKFWO3BB3JA6CQHC4E3JWPA/ Moderna Flu Vaccine Debate Could Resolve With Postmarket Study, FDA’s Makary Suggests: https://insights.citeline.com/pink-sheet/vaccines/moderna-flu-vaccine-debate-could-resolve-with-postmarket-study-makary-suggests-Y3R657N2JZABRGFOSKADM33YA4/ Horse Trading? Oz, Bourla Exchange MFN Codification, Vaccine Collaboration Requests: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/horse-trading-oz-bourla-exchange-mfn-codification-vaccine-collaboration-requests-X6UDDVOSMRBSTO5WC224IN6PTE/

Hansa Biopharma On Clearing The Path To Kidney Transplant

Mon, 16 Feb 2026 11:25:53 -0000

Renée Aguiar-Lucander, CEO of Hansa Biopharma, discussed the company’s leading asset, its journey toward US FDA approval and the trials and tribulations of completing a Phase III program.

ESG, Eco‑Pricing and Sustainable Packaging, with Steve Ramus

Mon, 16 Feb 2026 09:03:05 -0000

In Part 2 of HBW Insight’s conversation with sustainability leader Steve Ramus, we dig into the practical realities shaping the future of sustainability in consumer health, from what consumers are actually willing to pay for, to why packaging, supply chains and long‑term planning remain some of the industry’s toughest challenges. Drawing on two decades of sustainability and ESG experience, Ramus explains how consumer price sensitivity varies across markets, why sustainability can ultimately make companies more efficient, and how inflation complicates the conversation. We also explore the complex world of pharmaceutical packaging — where safety, stability and regulation often collide with expectations around plastics, recyclability and waste — and why progress, though slow, cannot stall. Timestamps: 2:00 – Will consumers pay more for sustainable OTCs? 7:00 – You don’t want to be unsustainable 9:00 – ESG is good for business 10:00 – Retailer expectations 15:00 – The state of play in OTC packaging 20:00 – The challenge of replacing plastic 23:00 – The challenge of recycling 27:00 – Sustainability priorities right now 31:00 – Supply chain 32:00 – The life of a sustainability professional Guest Bio: Steve Ramus is a global sustainability and ESG executive with 20 years of experience aligning strategy with business growth, risk mitigation, and value creation. As former Vice President of Sustainability & ESG at Perrigo, he led: ESG reporting, climate strategy, responsible sourcing, human rights due diligence, packaging circularity, community engagement and other initiatives that improved ESG ratings, delivered cost savings, and generated millions in incremental revenue. Steve advanced his career within the business having led teams in both HR and Sales, prior to his roles in sustainability.

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast) Feb. 16, 2026

Mon, 16 Feb 2026 03:44:27 -0000

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年2月13日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。本期要闻: Scrip问答—研发创新专题；拜耳“颠覆性”中风研究成果；阿斯利康精准肿瘤学战略；吉利德首席医学官谈研发管线；印度制药领袖论创新驱动。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-EP6IJB43CRG7XBFEWVVN7V3FXE/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Scrip's Five Must-Know Things - Feb.16, 2026

Mon, 16 Feb 2026 02:40:11 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended February 13, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – Scrip Asks on R&D Innovation; Bayer’s “paradigm-changing” stroke results; AstraZeneca’s precision oncology approach; Gilead’s CMO reflects on pipeline; and India’s pharma chiefs on driving innovation. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-EP6IJB43CRG7XBFEWVVN7V3FXE/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Drug Fix: US FDA Versus Moderna And The Changing Role Of Refuse To File Actions

Fri, 13 Feb 2026 16:46:01 -0000

Pink Sheet Executive Editor Derrick Gingery, Managing Editor Bridget Silverman, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss the US Food and Drug Administration’s controversial decision to refuse to file Moderna’s mRNA-1010 seasonal influenza vaccine candidate, including the unusual public airing of grievances (2:10), the changing issues sparking RTF actions (5:51), the uncertainty created by the decision and how vaccine sponsors should react going forward (16:54). More On These Topics From The Pink Sheet Moderna Cites Changing Advice As US FDA Refuses To File Flu Vaccine BLA: https://insights.citeline.com/pink-sheet/vaccines/moderna-cites-changing-advice-as-us-fda-refuses-to-file-flu-vaccine-bla-SRLIEHHMOFEWFPTLYJCXFIF5FM/ HHS Defends US FDA Refusal To File Moderna’s Flu Vaccine: https://insights.citeline.com/pink-sheet/vaccines/hhs-defends-us-fda-refusal-to-file-modernas-flu-vaccine-NULTQ6P6R5C6DDXZFMZROE3HRU/

Preventing Lung Disease in Preterm Babies

Mon, 09 Feb 2026 21:29:19 -0000

Bronchopulmonary dysplasia affects up to 90% of extremely preterm infants, yet no approved therapies exist. In this episode of the In Vivo podcast, Airway Therapeutics CEO Marc Salzberg discusses how their Phase Ib study of zelpultide alfa, a recombinant surfactant protein D, showed substantial reductions in BPD incidence and mechanical ventilation time. Salzberg explains the unique challenges of running neonatal trials, navigating regulatory pathways for vulnerable populations, and why preventing BPD could unlock broader respiratory applications. From ethics and enrollment to EMA approval and global expansion, this episode explores what it takes to develop breakthrough medicines for the smallest, most fragile patients.

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast) Feb. 9 , 2026

Mon, 09 Feb 2026 03:01:36 -0000

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年2月6日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。本期要闻—默克寻求填补Keytruda空缺；诺华力争突破最长专利到期期；诺和诺德预警销售额大幅下滑；辉瑞看好肥胖症治疗前景；礼来期待奥福格利普隆取得成功。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-JES32O67YRBSLC6UV2JFY5KPBQ/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Scrip's Five Must-Know Things - Feb. 9, 2026

Mon, 09 Feb 2026 01:21:44 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended February 6, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – Merck looks to fill Keytruda’s shoes; Novartis aims to push through largest expiry period; Novo warns of steep sales decline; Pfizer bullish on obesity; and Lilly expects orforglipron success. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-JES32O67YRBSLC6UV2JFY5KPBQ/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Drug Fix: US FDA Hiring Improves, But Can The Agency Avoid Oversight Erosion?

Fri, 06 Feb 2026 16:37:10 -0000

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the impact of new data showing US Food and Drug Administration hiring increasing, but net employee losses continuing (1:13), including how the issue could be reflected in the user fee program going forward (7:40) and where the strains will emerge as the agency continues to navigate its workload (11:43). More On These Topics From The Pink Sheet US FDA’s Drugs, Biologics Centers See Increased Hiring, But Not Enough To Overcome Departures: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-drugs-biologics-centers-see-increased-hiring-but-not-enough-to-overcome-departures-XGMD6U2QHFGULBLCBTRCBWATNQ/ PDUFA VIII: Industry Proposes Funding Changes To Reflect ‘Realistic Ability To Hire Staff’: https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/pdufa-viii-industry-proposes-funding-changes-to-reflect-realistic-ability-to-hire-staff-AALJBBI5BJEKLEBGIRFL6ZKDQA/ US FDA’s Failure To Implement Key Workforce Reforms Puts Oversight At Risk, GAO Says: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-failure-to-implement-key-workforce-reforms-puts-oversight-at-risk-gao-says-B64V7RAIQNBNBI57ID5ZU3DYAE/ A Strong Year For US FDA Approvals, But Warning Lights Flashing: https://insights.citeline.com/pink-sheet/product-reviews/approvals/a-strong-year-for-us-fda-approvals-but-warning-lights-flashing-OEYQQ4RRDVHEVPAFYXPQ4LRHOA/

Navigating A Changing EU And US Sustainability Landscape, With Steve Ramus

Mon, 02 Feb 2026 09:52:14 -0000

With the European Union rolling back parts of its Green Deal — including scaling back major legislation such as the Corporate Sustainability Reporting Directive and the Corporate Sustainability Due Diligence Directive — and the US splintering into state‑by‑state sustainability mandates, global OTC companies are facing a fresh wave of uncertainty around their sustainability strategies. It’s no surprise, then, that many are acting and investing more cautiously. But for sustainability expert Steve Ramus, formerly VP for Sustainability & ESG at Perrigo, now is precisely when leadership matters most. Sustainability teams, he argues, should be helping their executives and boards see that doing the “right” thing is also the competitive thing. Companies that keep moving through the uncertainty, he says, will be faster, leaner and far better prepared than those waiting on the sidelines. Timestamps: 3:00 – Introductions 4:50 – The state of sustainability in consumer health 9:00 – The business case for sustainability 14:30 – Where are we heading? 17:20 – Making the case for sustainability within companies 20:30 – The chilling effect of uncertainty

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast) Feb.2, 2026

Mon, 02 Feb 2026 02:58:11 -0000

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年1月30日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。本期要闻—阿斯利康宣布重大中国投资计划；诺华高管警示早期临床试验竞争压力；中国生物科技企业借IPO筹资海外试验；默克公司谈成功交易；深度解析印欧自由贸易协定。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-T7BHL2UUN5DY3ENU5ZRTCY7YIE/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Scrip's Five Must-Know Things - Feb. 2, 2026

Mon, 02 Feb 2026 02:30:17 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended January 30, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – AstraZeneca’s big China investment pledge; Novartis exec’s warning on early trial competitiveness; Chinese biotechs tap IPOs to fund foreign trials; Merck & Co on winning deals; and breaking down the India-EU free trade agreement. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-T7BHL2UUN5DY3ENU5ZRTCY7YIE/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Drug Fix: Understanding US FDA’s CNPV Application Reviews

Fri, 30 Jan 2026 17:38:13 -0000

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss details recently unearthed about the role center directors play in the Commissioner’s National Priority Voucher review process and the influence they could have over the review division (:32). They also discuss the CNPV Review Council’s membership (16:58) and the program’s resource needs (27:28). More On These Topics From The Pink Sheet US FDA CNPV Reviews Clarified: Center Director Approval Recommendations Not Binding, HHS Says: https://insights.citeline.com/pink-sheet/pathways-and-standards/review-pathways/us-fda-cnpv-reviews-clarified-center-director-approval-recommendations-not-binding-hhs-says-GRCFLKAPVZCWPGPT3I36B2WXI4/ FDA Voucher Program Approvals Will Come From Product Centers, But Ambiguity Lingers: https://insights.citeline.com/pink-sheet/pathways-and-standards/review-pathways/fda-voucher-program-approvals-will-come-from-product-centers-but-ambiguity-lingers-KBX2KFYONBEEVF4AJN3PV2AH4A/ US FDA Adds Facility Data To Commissioner’s Priority Voucher Pre-Submission Requirements: https://insights.citeline.com/pink-sheet/pathways-and-standards/review-pathways/us-fda-adds-facility-data-to-commissioners-priority-voucher-pre-submission-requirements-2XYJICOLOFBUNJVOTSXFNXSBSE/

How Senti Bio's Programmable Cell Therapy Tackles AML's Toxicity Problem

Tue, 27 Jan 2026 15:23:49 -0000

Tim Lu, CEO of Senti Bio, joins In Vivo to discuss how programmable cell therapies are solving oncology's targeting problem. Lu explains the logic-gated approach behind SENTI-202, an allogeneic CAR-NK therapy for relapsed/refractory AML that achieved 50% response rates in Phase 1 while avoiding the dose-limiting toxicities that have plagued other AML cell therapies. We cover the Phase 1 ASH 2025 data showing 39% complete remission rates (all MRD-negative) with 7.6-month median duration, the rationale for using NK cells over T cells, and why synthetic biology's three-target logic gates can distinguish cancer from healthy bone marrow cells. Lu also discusses plans for pivotal trials following RMAT designation, expansion into solid tumors, and where biotech innovation is accelerating versus where clinical translation bottlenecks remain. For biopharma professionals tracking cell therapy innovation, synthetic biology applications, and AML treatment advances.

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast) Jan.26, 2026

Mon, 26 Jan 2026 03:02:36 -0000

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年1月23日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。本期要闻—强生肿瘤业务前景；葛兰素史克收购Rapt交易；2026年最受期待的新药上市；摩根大通乐观的财务展望；以及Scrip对竞争格局的深度解析。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-RQH7ZGCHCBHZXOVSG7V53XIV54/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Scrip's Five Must-Know Things - Jan. 26, 2026

Mon, 26 Jan 2026 02:36:48 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended January 23, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – J&J’s oncology prospects; GSK’s Rapt deal; 2026’s biggest expected launches; optimistic financial outlook at JPM; and Scrip Asks about the competitive dynamics landscape. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-RQH7ZGCHCBHZXOVSG7V53XIV54/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Scrip JPM Podcast: Dealmaking, Regulatory And Commercial Expectations For 2026

Fri, 23 Jan 2026 21:08:03 -0000

Scrip senior editor Jessica Merrill, Scrip US managing editor Mandy Jackson and In Vivo senior reporter David Wild discuss trends and topics from interviews and presentations at the J.P. Morgan Healthcare Conference and Biotech Showcase.

Drug Fix: US FDA Review Speed Steady In 2025, But Will Staffing Impact In 2026?

Fri, 23 Jan 2026 16:29:15 -0000

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter, Managing Editor Bridget Silverman and Editor-in-Chief Nielsen Hobbs consider the US Food and Drug Administration’s average speed of a novel drug application review in 2025 (:34), including the loss of so-called “fast approvals” (5:33) and how reviewers managed to ignore the distractions caused by the changes (7:35). They also consider whether the layoffs and other departures will impact the review system in 2026 (11:16). More On These Topics From The Pink Sheet Average Metrics In A Turbulent Year: US FDA’s 2025 Median Review Times Match PDUFA Goals: https://insights.citeline.com/pink-sheet/pink-sheet-perspectives/average-metrics-in-a-turbulent-year-us-fdas-2025-median-review-times-match-pdufa-goals-FOEPKT27UFAHPDS36HKJFOHOQE/ It’s About Time: US FDA’s Review Speed For Novel Approvals In 2025: https://insights.citeline.com/pink-sheet/pink-sheet-perspectives/its-about-time-us-fdas-review-speed-for-novel-approvals-in-2025-6LMDCANRRZGWTIDSRKFVXCJRPY/ US FDA’s 2025 Staffing Turmoil Will Create 2026 Application Review Challenges: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-2025-staffing-turmoil-will-create-2026-application-review-challenges-AJIE7WRQ2ZFS7IOR5PA3OWFE2M/

Herantis’s ‘Elegant’ Approach In Parkinson’s

Wed, 21 Jan 2026 13:43:54 -0000

Antti Vuolanto, CEO of Herantis Pharma, discusses the significant unmet need in Parkinson’s disease and outlines Phase II plans for the company’s lead asset HER-096.

【3分で解説 #世界のファーマ】第28回ノバルティスが警鐘自国第一主義の弊害へ (Japanese-language podcast)

Mon, 19 Jan 2026 05:18:18 -0000

世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。今回取り上げた記事はこちら「Novartis Sounds Alarm Bell On Global Trade Policy（邦訳：ノバルティスが警鐘を鳴らす　自国第一主義の貿易政策めぐり）」 Article link: https://insights.citeline.com/scrip/drug-pricing/novartis-sounds-alarm-bell-on-global-trade-policy-GRXGDPFNE5E2VNHXZMK67CYEFI/ 公開書簡のURLはこちら Open Letter: https://www.novartis.com/sites/novartis_com/files/letter-to-global-governments.pdf?utm_campaign=pharmalittle&utm_medium=email&_hsenc=p2ANqtz--ND6BAwNYOXJlpATFKTFHmMTF6pv7a_72Ft7BD6JemCR-91pUUsDLTiRGjuqtDcyqTBbMVLBh_0RmYh8063YZw3HoWfPAwsgK6z1yCvjYrBnwAY4g&_hsmi=398727134&utm_content=398727134&utm_source=hs_email ※全文の閲覧には購読（有料）が必要です。世界の製薬ビジネスメディアScrip（スクリップ）とは？ https://www.citeline.com/ja-jp/products-services/commercialization/scrip

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast) Jan.19, 2026

Mon, 19 Jan 2026 03:14:03 -0000

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年1月16日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。本期要闻—摩根大通弥漫乐观情绪；Scrip探析2026年资本配置与并购趋势；安永指出中国并购增长值得关注；礼来收购Ventyx引发对NLRP3抑制剂的热议；诺和诺德基金会助力欧洲初创企业。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-XE634WMH7FHA3AHR4MPJ65VOQM/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Scrip's Five Must-Know Things - Jan. 19, 2026

Mon, 19 Jan 2026 02:19:25 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended January 16, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – optimism reigns at J.P. Morgan; Scrip Asks what 2026 holds for capital allocation and dealmaking; EY says keep eye on China as deals grow; Lilly’s Ventyx buyout raises NLRP3 inhibitor interest; and Novo Nordisk Foundation backs Europe startups. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-XE634WMH7FHA3AHR4MPJ65VOQM/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Drug Fix: Pazdur’s CNPV Problems, Could US FDA Release Unapproved Product Action Packages?

Fri, 16 Jan 2026 16:28:37 -0000

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter, and Editor-in-Chief Nielsen Hobbs consider the many concerns Richard Pazdur and others raised about the US Food and Drug Administration’s Commissioner’s National Priority Voucher Program (CNPV) (:37), including potential legal issues (10:35), as well as the possibility of releasing the full action package for an unapproved application, given the resources that likely would be required (18:16). More On These Topics From The Pink Sheet Commissioner’s National Priority Voucher Program Reflects US FDA Review Politicization, Pazdur Says: https://insights.citeline.com/pink-sheet/pathways-and-standards/review-pathways/commissioners-national-priority-voucher-program-reflects-us-fda-review-politicization-pazdur-says-A43CKFRDVBHTLESE6IQE6JXLGM/ US FDA Gauging Impact, Resource Use In Commissioner’s Voucher Pilot As Concerns Grow: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-gauging-impact-resource-use-in-commissioners-voucher-pilot-as-concerns-grow-7WQB3TOQERGXJPAIV5465GOBLM/ With Unapproved Drug Complete Response Letters Now Public, Are Action Packages Next?: https://insights.citeline.com/pink-sheet/product-reviews/complete-response-letters/with-unapproved-drug-complete-response-letters-now-public-are-action-packages-next-S4Y5ANUYE5DOTC7YVTALA3GPIE/

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast) Jan.13, 2026

Tue, 13 Jan 2026 06:31:24 -0000

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2026年1月9日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。本期要闻—口服版Wegovy在美国上市； 2025年中盘股最大催化剂；去年小盘股转型与僵尸股清算；去年上市新药面临的商业逆风；以及中国企业全球三期临床动态。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-ZV4GVVROYBEN7I6DQBOMQ3A3XE/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Scrip이 묻다: 2026년 바이오의약품 업계 전망은? 자본배분과 딜메이킹 (Korean-language podcast)

Tue, 13 Jan 2026 06:24:10 -0000

Scrip의 2026년 글로벌 제약바이오 산업 전망 (1부: 자본배분과 딜메이킹)을 요약한내용입니다. https://insights.citeline.com/scrip/scrip-asks/scrip-asks-what-does-2026-hold-for-biopharma-part-1-capital-allocation-and-dealmaking-U3B4EUN3GZGNXM6QI3ZGXVMNZY/ Playlist: soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini

Scrip's Five Must-Know Things - Jan. 13, 2026

Tue, 13 Jan 2026 03:09:16 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended January 9, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – oral Wegovy launches in the US; the biggest mid-cap catalysts in 2025; small cap pivots and zombie killers last year; commercial headwinds for last year’s launches; and a look at Chinese firms’ global Phase III activity. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-ZV4GVVROYBEN7I6DQBOMQ3A3XE/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Drug Fix: Oncology Stalwart Richard Pazdur Leaves US FDA

Fri, 09 Jan 2026 16:10:16 -0000

PreVision Policy Founding Member Michael McCaughan joins Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs to discuss the career and legacy of Richard Pazdur, the long-time head of the US Food and Drug Administration’s oncology drug review division and Oncology Center of Excellence. They consider his brief stint as Center for Drug Evaluation and Research director and decision to retire (:55), his impact on oncology (4:36), as well as reflect on his famous “Pazdur Moments” (18:41), the future of legacy programs like Project Orbis (28:52), and whether the FDA can find another leader like him (33:54). More On These Topics From The Pink Sheet US FDA’s Richard Pazdur: Appreciating An Extraordinary Career: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-richard-pazdur-appreciating-an-extraordinary-career-YD2GBQ7WOZHM5BNAKWJF4OQVFM/ Modernizing Accelerated Approval: One Of Pazdur’s Biggest Legacies: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/modernizing-accelerated-approval-one-of-pazdurs-biggest-legacies-4QPXDRZ7SNBE7EUOG5VWWILGDY/

Building a Nasal First line of Defense Against H5N1

Mon, 05 Jan 2026 22:08:14 -0000

Intranasal vaccines are back in the spotlight as highly pathogenic avian influenza spreads among birds and spills over into mammals, including recent cases in dairy and poultry workers. In this episode of In Vivo, senior pharma and biotech reporter David Wild talks with Chad Costley, CEO of BlueWillow Biologics and Meagan Deming, an infectious disease researcher at the University of Maryland School of Medicine about a novel intranasal recombinant H5 flu vaccine that aims to stop infection at the gate by building mucosal immunity in the nose. They discuss recent Phase I data, pandemic‑flu preparedness, BARDA/NIH funding realities, and how BlueWillow's NanoVax platform could extend to other major respiratory threats, including TB.

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast)

Mon, 22 Dec 2025 03:33:02 -0000

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2025年12月19日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。本期要闻——再生元夹在成功与专利到期之间；第三季度十大畅销药物；礼来Retatrutide重塑减重标准；辉瑞坚守疫苗投资；赛诺菲在托布替尼困境中仍保持乐观。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-XA4W4OYCVRCSNHW5ZL7TUFJF2U/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Scrip's Five Must-Know Things - Dec. 22, 2025

Mon, 22 Dec 2025 02:21:11 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended December 19, 2025. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – Regeneron caught between success and expiry; Q3’s top 10 drugs; Lilly’s Retatrutide Raises Weight-Loss Bar; Pfizer stands by vaccines investment; and Sanofi Upbeat Despite Tolebrutinib Tribulations. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-XA4W4OYCVRCSNHW5ZL7TUFJF2U/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

“We Are On The Cusp Of A Real Revolution”: OHC Rare Disease Center Boosts Innovation

Fri, 19 Dec 2025 17:31:38 -0000

Matthew Wood, director and chief scientific officer at Oxford-Harrington Rare Disease Center, discusses the state of rare disease R&D, the evolving landscape of genomics and genetic therapies, and the challenges around the biopharma industry’s narrow focus on only 5-10% of rare diseases.

Scrip Awards Podcast, 2025 Winners

Fri, 19 Dec 2025 16:43:08 -0000

This podcast brings you highlights from Scrip Awards 2025, including wins for AstraZeneca, Syndax, Akeso and Summit Therapeutics and the Lifetime Achievement Award for Flagship Pioneering's Noubar Afeyan.

Datamonitor Healthcare Podcast: A Deep Dive into Dry AMD

Fri, 19 Dec 2025 08:05:24 -0000

Emma Wille and Summer Colling speak with ophthalmology expert, Joseph Jacob, to discuss the latest developments in dry age-related macular degeneration (dry AMD), including current treatments, emerging therapies, regulatory challenges, and the unmet needs shaping the future of patient care.

Scrip M&A Podcast: PwC's Dealmaking Preview for 2026

Tue, 16 Dec 2025 20:22:24 -0000

Scrip senior writer Joseph Haas and PwC analyst Roel Van den Akker look back on biopharma sector dealmaking in 2025, why deal values rose from 2024's lows, and look ahead to what the trends mean heading into 2026 in this latest edition of the Scrip M&A Podcast.

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast)

Mon, 15 Dec 2025 03:32:41 -0000

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2025年12月12日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。本期聚焦美国血液学会（ASH）会议五大关键成果：Jaypirca有望成为一线疗法；Kite公司Anito-cel在多发性骨髓瘤领域的进展；新一代CAR-T疗法；Kelownia公司CAR-T疗法的早期体内数据；以及诺华公司ianalumab在ITP治疗中的潜力。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-RFOOY2665REEZEN5SMJ2GW27EY/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Scrip's Five Must-Know Things - Dec. 15, 2025

Mon, 15 Dec 2025 02:06:09 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended December 12, 2025. This week, a focus on five key results from the American Society of Hematology (ASH) meeting – Jaypirca headed for the front line; Kite’s Anito-cel in multiple myeloma; next-generation CAR-T approaches; Kelownia’s early in vivo CAR-T data; and Novartis’s ianalumab’s potential in ITP. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-RFOOY2665REEZEN5SMJ2GW27EY/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast)

Mon, 08 Dec 2025 04:33:31 -0000

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2025年12月5日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。本次要闻: 特朗普在英国药品定价谈判中获胜；诺和诺德阐释司美格鲁肽治疗阿尔茨海默病的依据；强生与诺华达成年度最大并购交易；CAR-T疗法成效参差分析；阿克索制药的伊沃尼西马布后续目标。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-UZSVLBBSQRAKNJC7GDZWILMAT4/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Scrip's Five Must-Know Things - Dec. 8, 2025

Mon, 08 Dec 2025 03:06:55 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended December 5, 2025. In this episode: Trump’s UK drug pricing win; Novo explains semaglutide Alzheimer's rationale; J&J and Novartis on this year’s biggest M&A deals; a look at the mixed performance of CAR-Ts; and Akeso’s goals beyond ivonescimab. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-UZSVLBBSQRAKNJC7GDZWILMAT4/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Overcoming Drug Resistance In Oncology With Kairos Pharma's Neil Bhowmick

Fri, 05 Dec 2025 19:58:28 -0000

Drug resistance derails even the most advanced cancer treatments, but what if we could restore sensitivity to existing therapies instead of starting over? Neil Bhowmick, chief scientific officer at Kairos Pharma, joins In Vivo to discuss how his company is tackling resistance in oncology. We explore the company's lead asset, ENV-105, which is showing over 13 months of progression-free survival in Phase II prostate cancer trials by resensitizing tumors to hormone therapy, with significantly lower toxicity than standard alternatives like chemotherapy or radiopharmaceuticals. Bhowmick explains the complex biology behind different resistance mechanisms, shares early data on GITR-modulating therapies designed to expand T cell populations for immunotherapy, and discusses their approach to developing companion biomarkers for patient selection. We also dive into the clinical and commercial rationale for combination approaches and what milestones to watch in the coming year.

Drug Fix: Understanding the US FDA’s CDER Leadership Shuffle

Fri, 05 Dec 2025 16:33:32 -0000

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Editor-in-Chief Nielsen Hobbs break down the pending retirement of Center for Drug Evaluation and Research Director Richard Pazdur and appointment of Tracy Beth Høeg as the interim replacement (4:51), including the potential impact on sponsors (15:46). They also discuss whether Høeg will take time to learn CDER operations before making changes (19:38), as well as the possibility of yet another CDER director being hired in the coming weeks or months (23:18). More On These Topics From The Pink Sheet US FDA Faces Another Leadership Crisis As Drugs Center Director Richard Pazdur Retires: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/breaking-us-fda-cder-director-richard-pazdur-retiring-SUPZZ4JEQ5GVHEEH4RPDLCNIBY/ Tracy Beth Høeg Named New Acting US FDA CDER Director: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/tracy-beth-hoeg-named-new-acting-us-fda-cder-director-3AYJZJAMBVG6HNPX3FJ7IBCDHQ/ US FDA Sending Pazdur Back To Oncology Office: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-sending-pazdur-back-to-oncology-office-KVBDIDT2RVF4JAZ7FCZHN46XXU/

【3分で解説 #世界のファーマ】第27回中国バイオ企業の成長 5つのテーマ (Japanese-language podcast)

Mon, 01 Dec 2025 01:41:44 -0000

世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。今回取り上げた記事はこちら「The Rise of China Biopharma – Five Themes In 2025（邦訳：中国バイオファーマの勃興　2025年注目のテーマ5つとは）」 URL: https://insights.citeline.com/scrip/r-and-d/clinical-trials/the-rise-of-china-biopharma-five-themes-in-2025-GEB2XLG3CNDONIO5HE4S2FZOVI/ ※全文の閲覧には購読（有料）が必要です。世界の製薬ビジネスメディアScrip（スクリップ）とは？ https://www.citeline.com/ja-jp/products-services/commercialization/scrip

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast)

Mon, 01 Dec 2025 01:18:32 -0000

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2025年11月28日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。本次要闻: 2027年医保降价幅度或低于CMS预期；赛尔安泰在DLL3肺癌ADC竞赛中领先；强生抗tau阿尔茨海默病药物posdinemab二期试验失败；拜耳阿苏德克赛安三期中风试验意外获胜；辉瑞/安斯泰来Padcev膀胱癌研究首获重大突破。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-R4RCDF2RXVGVHPEX2WQ7A3JVKU/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Scrip's Five Must-Know Things - Dec. 1, 2025

Mon, 01 Dec 2025 00:32:32 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended November 28, 2025. In this episode: 2027 Medicare price cuts likely not as large as CMS estimates; Zai Lab leads DLL3 lung cancer ADC race; Phase II failure for J&J’s Alzheimer’s asset posdinemab; Bayer's positive Phase III data for asundexian in stroke; and Pfizer/Astellas’s Padcev's first big win in bladder cancer study. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-R4RCDF2RXVGVHPEX2WQ7A3JVKU/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

글로벌 바이오 리더들, M&A 열기 속 낙관론 확산 (Korean-language podcast)

Fri, 28 Nov 2025 03:56:09 -0000

최근 런던에서 열린 Jefferies 글로벌 헬스케어 컨퍼런스를 취재한 Scrip기사를 요약한 내용입니다 https://insights.citeline.com/scrip/business/start-ups-and-smes/jefferies-25-biotech-leaders-bullish-as-ma-heats-up-EAHTR2MNHJE65E74WLIMBXXK5I/ Playlist: soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast)

Tue, 25 Nov 2025 05:29:49 -0000

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2025年11月21日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。本次要闻: GLP-1药物之外的肥胖治疗新局；并购热潮中生物科技巨头的乐观预期；百时美施贵宝Milvexian遭遇挫折；临床专家解读MASH疗法演进；日本企业上半年业绩喜忧参半。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-MXUR6OEDNNAEPPTTZ4YZKH55SU/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Scrip's Five Must-Know Things - Nov. 25, 2025

Tue, 25 Nov 2025 03:35:23 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended November 21, 2025. In this episode: obesity beyond GLP-1s; biotech leaders bullish as M&A heats up; BMS’s milvexian setback; clinicians on evolution of MASH treatment; and Japan H1 results mixed. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-MXUR6OEDNNAEPPTTZ4YZKH55SU/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Charles River CSO Calls For Collaboration On Non-Animal Models

Mon, 24 Nov 2025 13:32:34 -0000

Charles River’s CSO Julie Frearson outlines the FDA’s planned transition away from animal testing, changing attitudes to artificial intelligence, and the move to New Alternative Methods.

Over The Counter Special: Enabling Digital Self-Care, With PAGB’s Michelle Riddalls

Wed, 19 Nov 2025 07:01:04 -0000

The UK’s consumer healthcare industry association, PAGB is publishing a series of blog posts for Self-Care Week – an annual awareness campaign in the UK organized by the Self Care Forum, held this year from 17-23 November. In this second part of a special episode of HBW Insight’s Over the Counter podcast, we catch up with the association’s CEO Michelle Riddalls, to talk about what the association is doing to promote digital health. As part of the UK government’s plans for reforming the country’s National Health Service, PAGB is asking for the widely used UK NHS app to not only advise people on how to self-care but also to take users to OTC brand websites that can help them to self-manage their conditions appropriately. We also discuss the advantage of having digital apps and self-care information generally linked to trusted umbrella brands. Timestamps 2:00 – PAGB’s digital health strategy 6:00 – The NHS app and self-care brands 12:00 – Self-care apps 15:30 – The importance of brands Guest Bio Michelle Riddalls OBE is chief executive officer of PAGB, the consumer healthcare association, which represents the manufacturers of branded OTC medicines, self-care medical devices and food supplements in the UK. Prior to joining PAGB, Riddalls was director of regulatory affairs for the Northern European Cluster at Pfizer Consumer Healthcare, where she was integral in the highly successful POM to GSL reclassification of Nexium Control and the Viagra Connect POM to P switch. Michelle has been recognized across a number of industry awards, including the Women in Trade Powerlist in 2024, and was awarded an OBE for outstanding services to consumer health in the King’s 2025 New Year Honours.

Digital Health Roundup: BCIs Surge Ahead, Oura Eyes BP Clearance, AI Faces New Scrutiny

Tue, 18 Nov 2025 21:27:06 -0000

In this week’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights her interviews with leaders at brain-computer interface developers Synchron and INBRAIN about funding, clinical trials and partnerships. Brian Bossetta discusses Oura’s goal to secure US FDA clearance for a blood pressure feature for its smart ring. Elizabeth Orr highlights an FDA expert panel considering regulation of generative AI tools for mental health and Shubham Singh shines a light on Choice’s efforts to develop a new form of contraceptive for women.

Over The Counter Special: Unlocking Switch-Driven Growth, With PAGB’s Michelle Riddalls

Tue, 18 Nov 2025 09:00:57 -0000

The UK’s consumer healthcare industry association, PAGB is publishing a series of blog posts for Self-Care Week – an annual awareness campaign in the UK organized by the Self Care Forum, held this year from 17-23 November. In this special episode of HBW Insight’s Over the Counter podcast, we catch up with the association’s CEO Michelle Riddalls, to talk about what the association is doing to promote Rx-to-OTC switch in the UK. According to Riddalls, two-thirds of PAGB members see reclassification as a key pillar of growth in the next 10-15 years. The UK government has also announced it wants to see switch applications for 16 medical conditions and categories, including sleep, pain, allergy and women's intimate health. Through initiatives like the Reclassification Alliance, PAGB is working hard to unlock this significant growth opportunity for the UK consumer health industry, Riddalls explains. Timestamps 3:00 – Introductions 4:00 – PAGB and Self-Care Week 5:30 – How PAGB is helping to enable Rx-to-OTC switch 8:00 – The benefits of switching for the consumer health industry 11:00 – Riddalls’ switch experience 15:00 – UK government’s switch agenda 18:00 – Switch barriers 22:00 – Thinking outside the box Guest Bio Michelle Riddalls OBE is chief executive officer of PAGB, the consumer healthcare association, which represents the manufacturers of branded OTC medicines, self-care medical devices and food supplements in the UK. Prior to joining PAGB, Riddalls was director of regulatory affairs for the Northern European Cluster at Pfizer Consumer Healthcare, where she was integral in the highly successful POM to GSL reclassification of Nexium Control and the Viagra Connect POM to P switch. Michelle has been recognized across a number of industry awards, including the Women in Trade Powerlist in 2024, and was awarded an OBE for outstanding services to consumer health in the King’s 2025 New Year Honours.

Data-Driven Insights Reveal The Growth Engines Powering 2026 Life Sciences

Mon, 17 Nov 2025 17:40:40 -0000

In this special In Vivo podcast episode, executive editor Lucie Ellis-Taitt is joined by an expert panel of Citeline journalists – Ashley Yeo, David Wild, Jessica Merrill and data journalist Edwin Elmhirst – to explore the trends set to reshape the biopharma and medtech sectors as we head into 2026.

EY's Arda Ural on IPOs, Financial Markets and Tarrifs

Thu, 13 Nov 2025 18:48:36 -0000

After two of the toughest years in biotech history, are we finally seeing a turnaround? EY's Arda Ural discusses the long-awaited recovery in biotech IPOs, the evolving capital markets landscape and how tariffs and Trump RX are reshaping biopharma supply chains. In this wide-ranging conversation, Ural unpacks the three key factors driving IPO recovery — Fed rate cuts, improving valuations, and reduced macro uncertainty — while sharing hard data on what's actually working in 2024. He explains why platforms without products are struggling to raise venture capital, how the bid-ask spread in M&A deals reflects ongoing valuation disagreements and why China's emergence as a competitor in novel drug development represents a fundamental shift for the industry. Whether you're navigating early-stage financing, preparing for an IPO, or planning strategic transactions, this episode delivers actionable insights on capital markets, policy impacts and the fundamentals that will determine who succeeds in the next phase of biotech innovation.

Datamonitor Healthcare Podcast: ESMO 2025

Wed, 12 Nov 2025 17:33:01 -0000

Summer Colling and Emma Wille speak with Nkiru Ibeanu, Anna Simmons, and David Dahan from the oncology team about some of the most exciting data presented at the 2025 European Society For Medical Oncology conference.

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast)

Mon, 10 Nov 2025 06:08:54 -0000

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2025年11月1日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。本次要闻: 辉瑞对Metsera的坚定收购计划；礼来公司肥胖症治疗领域的强劲势头；默克公司MFN协议谈判进展；诺华公司干燥综合征研究的积极成果；以及中国对美国创新领域施加的日益增大的压力。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-2K33BM6BLBDU7JH7QMETUXUKPE/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Scrip's Five Must-Know Things - Nov. 10, 2025

Mon, 10 Nov 2025 03:01:22 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended November 1, 2025. In this episode: Pfizer’s unwavering pursuit of Metsera; Lilly’s obesity momentum; Merck & Co.’s MFN negotiations; Novartis’s promising Sjögren’s results; and the rising Chinese pressure on US innovation. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-2K33BM6BLBDU7JH7QMETUXUKPE/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Drug Fix: Examining George Tidmarsh’s Departure As Head Of US FDA’s Drug Center

Fri, 07 Nov 2025 16:57:56 -0000

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs take a deep dive into the circumstances of George Tidmarsh’s departure as director of the US Food and Drug Administration’s Center for Drug Evaluation and Research (:30). They also consider the long-term impact on the agency (11:50) and try to place it in context compared to other crises in its history (31:24). More On These Topics From The Pink Sheet Breaking: George Tidmarsh Out As US FDA Drug Center Director: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/breaking-george-tidmarsh-out-as-us-fda-drug-center-director-MI2NEWEM6ZFP7GP66ZQJL76N2Q/ Former US FDA CDER Director Says He Played Key Role In Stealth’s Elamipretide Approval: https://insights.citeline.com/pink-sheet/product-reviews/drug-review-profiles/us-fda-cder-director-says-he-played-key-role-in-stealths-elamipretide-approval-VAEUL5PU75GBXCMC3QOYTA32WI/ Tidmarsh Creates More Instability And Uncertainty For US FDA, Industry: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/tidmarsh-creates-more-instability-and-uncertainty-for-us-fda-industry-DODHAMVW5REBPPHBUUJHV6PZTU/ US FDA’s Richard Pazdur Says ‘No’ To CDER Director’s Spot: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/breaking-us-fdas-richard-pazdur-offered-cder-director-spot-said-no-RZK4BW7EX5F5RLG6HG2JSDCKAE/ FDA Office of New Drugs Director Mary Thanh Hai Not Interested In CDER Director Job: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/fda-office-of-new-drugs-director-mary-thanh-hai-not-interested-in-cder-director-job-XKOFXETTWVAXFB22BQ3MJ7ONQ4/

Podcast: Beyond The Checkpoint — Next-Gen Strategies In Immuno-Oncology

Thu, 06 Nov 2025 04:20:53 -0000

Join Sarah Anderson, Therapeutic Strategy Director, Oncology at Novotech, and Izabela Chmielewska from Citeline as they explore how next-generation immuno-oncology strategies are reshaping cancer research. From emerging modalities to smarter trial design and evolving regulatory expectations, discover what’s driving the next wave of innovation in oncology.

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast)

Tue, 04 Nov 2025 03:54:54 -0000

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2025年10月31日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。本次要闻: 本期要闻——第三季度并购交易回暖；诺华收购Avidity后并购火力依旧；韩美制药肥胖症候选药物展现三期试验潜力；英伟达合作推动礼来人工智能计划；礼来收购Adverum强化基因疗法布局。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-MQMX2YHSAVHBTJFR4RAEAYNFNQ/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Scrip's Five Must-Know Things - Nov. 4, 2025

Tue, 04 Nov 2025 03:23:53 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended October 31, 2025. In this episode: third quarter dealmaking picks up; Novartis still has M&A firepower even after Avidity acquisition; Hanmi’s obesity contender shows Phase III promise; NVIDIA partnership progresses Lilly’s AI plans; and Lilly builds gene therapy push with Adverum buy. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-MQMX2YHSAVHBTJFR4RAEAYNFNQ/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Drug Fix: US FDA Streamlines Biosimilar Development Requirements, Clarifies Inspection Reform

Fri, 31 Oct 2025 15:21:05 -0000

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the impact of the US Food and Drug Administration announcement that a comparative efficacy study is no longer a prerequisite for biosimilar approval (:35), as well as the upcoming guidance stating the interchangeability switching study requirement will be dropped (11:25). They also discuss agency efforts to clarify the intent of the upcoming inspection force “Simple Reform” (15:13). More On These Topics From The Pink Sheet US FDA’s Makary Wants Lower Biosimilar Launch Prices As Clinical Study Mandate Changed: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/biosimilars/us-fdas-makary-wants-lower-biosimilar-launch-prices-as-clinical-study-mandate-changed-5ARJRC6QYBBMTLTQ5S46F5YGXQ/ Biosimilar Interchangeability Guidance Eliminating Switching Studies Coming Soon: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/biosimilars/biosimilar-interchangeability-guidance-eliminating-switching-studies-coming-soon-ILNP4IGYJZGZLAJVDZ77URZDNQ/ ‘Simple Reform’ Not A Step Back From Program Alignment, US FDA’s Elizabeth Miller Argues: https://insights.citeline.com/pink-sheet/compliance/manufacturing/simple-reform-not-a-step-back-from-program-alignment-us-fdas-elizabeth-miller-argues-TCTFWMGBARD6VLRDT7YWUZBJQE/

Decoding Cell Differentiation: How AI Foundation Models Are Reshaping Regenerative Medicine

Fri, 31 Oct 2025 13:17:09 -0000

What if we could train AI to understand how stem cells become any cell type in the human body? In this episode of the In Vivo Podcast, host David Wild sits down with Micha Breakstone (CEO & Co-founder) and Samantha Dale Strasser (VP of Strategy) from Somite.AI to explore how their company is using foundation models to revolutionize cell therapy development. Somite has pioneered a breakthrough approach that generates cell differentiation data at 1000x the efficiency of traditional methods using proprietary hydrogel capsule technology. By capturing millions of trajectories showing how cells respond to signals over time, they're building DeltaStem—a foundation model that could do for developmental biology what AlphaFold did for protein structure prediction. Topics covered: - How bringing cells to signals (rather than signals to cells) unlocks exponential scale - Why wet lab innovation is just as critical as AI models - Manufacturing optimization: improving purity, reducing variability, and cutting costs - From beta cells for diabetes to brown fat for metabolic disease—the therapeutic pipeline - Why even AI experts underestimate what's coming in the next decade - Lessons from building biotech companies from academic concepts to commercial ventures Whether you're in pharma, biotech, AI or just fascinated by the intersection of technology and human biology, this conversation offers a grounded look at how foundation models are moving from hype to real therapeutic impact.

Scrip M&A Podcast: What's Next For Dealmaking In The Obesity Space?

Fri, 31 Oct 2025 02:47:22 -0000

Joseph Haas, senior writer, Scrip, speaks to guest panelists Robert Darwin, partner, Sidley law firm, and Arda Ural, Americas Life Sciences Leader, EY.

국내 바이오텍 펀딩 활성화를 위해 새로운 촉매제 필요 (Korean-language podcast)

Fri, 31 Oct 2025 01:16:25 -0000

스톤브릿지벤쳐스의 김현기 상무는 Scrip과의 인터뷰에서 벤처캐피탈의 국내 바이오 투심 회복을 제약하는 요인과 투자 고려사항, 전략 등을 이야기했습니다. https://insights.citeline.com/scrip/leadership/interviews/a-vc-perspective-on-korean-bioventures-new-catalysts-needed-to-jumpstart-activity-Z7IXGZWZVVGKFDPNOWNJJPMWLQ/ Playlist: soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast)

Mon, 27 Oct 2025 02:54:01 -0000

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2025年10月24日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。本期聚焦柏林欧洲医学肿瘤学会会议的新成果：Enhertu在早期乳腺癌中的应用；Padcev/Keytruda在膀胱癌领域的突破；Pluvicto的III期试验成功；Trodelvy与Datroway在乳腺癌治疗领域的较量；默克公司为乳腺癌治疗带来新希望。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-EWX3A6U4TBE5NPDYXHIJSWDO3A/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Scrip's Five Must-Know Things - Oct. 27, 2025

Mon, 27 Oct 2025 02:13:38 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended October 24, 2025. In this episode we focus on the most significant results presented at the European Society for Medical Oncology meeting in Berlin: Enhertu in early-stage breast cancer; Padcev/Keytruda in bladder cancer; Phase III wins for Pluvicto; Trodelvy and Datroway in breast cancer tussle; and Merck & Co. raises hopes in breast cancer. . Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-EWX3A6U4TBE5NPDYXHIJSWDO3A/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Drug Fix: Another FDA Inspection Reorg, Industry Navigating New DTC Landscape

Fri, 24 Oct 2025 15:52:29 -0000

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs explain the reasons for the US Food and Drug Administration’s planned “Simple Reform” of its inspection group, including the move away from specialized teams (:44). They also consider industry’s current thinking on best practices for navigating the agency’s new position on direct-to-consumer ad regulation (18:45). More On These Topics From The Pink Sheet US FDA Plans Move Back To More Generalist Inspectorate: https://insights.citeline.com/pink-sheet/compliance/us-fda-plans-move-back-to-more-generalist-inspectorate-5V3573KXHFAJXH6LVC6NSXW37M/ Industry Rethinking Visual Elements And Quality-Of-Life Claims After US FDA Drug Ad Crackdown: https://insights.citeline.com/pink-sheet/compliance/marketing-and-advertising/industry-rethinking-visual-elements-and-quality-of-life-claims-after-us-fda-drug-ad-crackdown-WMXPANFVC5B55GZZQ6IWJG4FRE/ US FDA Ad/Promo Crackdown Letters Came From OPDP Staff, Not Artificial Intelligence: https://insights.citeline.com/pink-sheet/compliance/marketing-and-advertising/us-fda-adpromo-crackdown-letters-came-from-opdp-staff-not-artificial-intelligence-RKTSXQ5ZV5BPJD4DXGAOS5SS5Q/

Winning Biotech Investors Through Strategic Partnerships and Trial Innovation

Wed, 22 Oct 2025 10:07:26 -0000

Biotech funding is tougher than ever, but some companies still win big. Join Claire Riches, VP, Clinical Solutions, Citeline and Alistair McDonald, CEO of Worldwide Clinical Trials as they reveal insider strategies for securing investors, navigating partnerships, and turning innovative science into real-world success. View the video series and find out more information here: https://www.citeline.com/biotech

Innovating Autoimmune Treatment with In Vivo CAR-T

Tue, 21 Oct 2025 13:22:10 -0000

As the potential of in vivo CAR-T therapy moves closer to clinical reality, biotech innovators are reimagining what’s possible in autoimmune disease. With groundbreaking scientific advances and evolving regulatory perspectives, this next generation of cell therapy could redefine how immune-mediated conditions are treated. In this episode, Pete Robinson, Therapeutic Strategy Director, Novotech, joins Meredith Landry, Managing Editor, Custom Content, Citeline, to discuss how in vivo CAR-T is opening new possibilities for autoimmune therapies—and what it will take to translate early promise into patient impact. They explore: • The breakthrough potential of in vivo CAR-T—and what could make it a true game-changer for autoimmune disorders • Key developments and considerations to realize clinical success • Global landscape for early phase clinical trials

How Olon’s fully integrated, end-to-end ADC capabilities drive quality and scale

Mon, 20 Oct 2025 15:21:32 -0000

Hear experts Matthieu Culié and Alessandro Agosti as they discuss how Olon stands out in a competitive landscape through its fully integrated end-to-end ADC manufacturing expertise, global operations, impurity control and strategic facilities.

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast)

Mon, 20 Oct 2025 02:28:42 -0000

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2025年10月17日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。本次要闻: 大型药企仍看好细胞与基因疗法前景；ESMO会议关注焦点；科伦制药TROP2抗体药物偶联物创全球首例；强生预期与白宫政策保持一致；BioFuture会议揭示行业不确定性。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-ADAR4VZIGRFIFCOMXI7UTZS76U/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Scrip's Five Must-Know Things - Oct. 20, 2025

Mon, 20 Oct 2025 01:17:13 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended October 17, 2025. In this episode: big pharma still sees value in cell and gene therapy; what to look out for at ESMO; world first for Kelun’s TROP2 ADC; J&J expects alignment with White House policies; industry uncertainties aired at BioFuture meeting. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-ADAR4VZIGRFIFCOMXI7UTZS76U/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Drug Fix: US FDA Involved In Astra Zeneca’s Drug Pricing Deal, DOJ’s Off-Label Promotion Policy

Fri, 17 Oct 2025 15:43:36 -0000

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Editor-in-Chief Nielsen Hobbs discuss the reasons US Food and Drug Administration Commissioner Martin Makary could have helped negotiate the Most Favored Nation drug pricing deal with Astra Zeneca (:30) and the deal’s potential impact on the 340B program (16:35). They also consider the Justice Department’s alternative interpretation of off-label promotion regulations and the effect on the scientific exchange of information about drugs (19:16). More On These Topics From The Pink Sheet US FDA Commissioner’s Involvement In AstraZeneca Pricing Deal Raises Ethical, Legal Questions: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/us-fda-commissioners-involvement-in-astrazeneca-pricing-deal-raises-ethical-legal-questions-IJV4LMTDA5E65KCOFQUQM76GCA/ EMD Serono IVF Candidate Among First US FDA Priority Voucher Recipients As Part Of MFN Deal: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/emd-serono-ivf-candidate-among-first-us-fda-priority-voucher-recipients-as-part-of-mfn-deal-LKHA6VRTKRE6DJERGNCWCGMBF4/ Manufacturer Most Favored Nation Deals: How They Could Be Protected From 340B: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/manufacturer-most-favored-nation-deals-how-they-could-be-protected-from-340b-FALSG7GHM5GQBFN3I5SPERJIYU/ Off-Label Promotion: DOJ May Take New Look At Scientific Information Exchange: https://insights.citeline.com/pink-sheet/legalandip/litigation/off-label-promotion-doj-may-take-new-look-at-scientific-information-exchange-R62PQJFQTRBCVGCZE57GWM3Q3Q/

Adalvo: Exploring European B2B Pharma’s Next Steps

Fri, 17 Oct 2025 13:21:27 -0000

Adalvo: Exploring European B2B Pharma’s Next Steps by Citeline

Lupus Clinical Development Enters a New Era of Innovation

Thu, 16 Oct 2025 21:10:04 -0000

Join host David Wild as he speaks with Stacie Bell, chief clinical research officer at Lupus Therapeutics, about the dramatic transformation happening in lupus drug development. From a field once avoided by pharma companies to one generating unprecedented excitement, Bell discusses how her organization's 62-center network is revolutionizing clinical trials through patient engagement and scientific innovation. Learn about promising oral therapies, Genentech's cancer drug Gazyva under FDA review for lupus nephritis, cell therapy approaches offering potential long-term remission and how combination treatments may become the new standard. Bell shares insights on overcoming clinical trial barriers, advancing biomarker research and ensuring representative participation from lupus communities. A must-listen for anyone interested in autoimmune disease research, clinical development innovation, and patient-centered drug development.

Essential Pharma – Following A Patient First Philosophy

Wed, 15 Oct 2025 13:36:16 -0000

In Vivo spoke with Emma Johnson, CEO of Essential Pharma, to discuss the company's strategic priorities and plans for growth as it expands its portfolio in rare diseases.

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast)

Tue, 14 Oct 2025 03:18:01 -0000

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2025年10月10日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。本次要闻: 生物制药融资重燃乐观情绪；CAR-T疗法适应症扩大将考验医疗体系承载力；高德美在皮肤科领域表现超出预期；安进推出面向患者的Repatha直接销售计划；Datroway在乳腺癌领域取得生存期突破。 Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-JZ326HAB2ZHB7E3Z5PNIUBITQQ/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Scrip's Five Must-Know Things - Oct. 14, 2025

Tue, 14 Oct 2025 02:54:09 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended October 10, 2025. In this episode: biopharma financing regaining optimism; larger CAR-T indications to strain healthcare capacity; Galderma punching above weight in dermatology; Amgen’s direct-to-patient Repatha program; and Datroway’s survival success in breast cancer. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-JZ326HAB2ZHB7E3Z5PNIUBITQQ/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Cereno Scientific Turns To Old Drug For Rare Cardiopulmonary Diseases

Fri, 10 Oct 2025 17:45:56 -0000

Cereno Scientific CEO Sten Sörensen discusses how his company is repurposing a 60-year-old epilepsy drug as a potential game-changer for pulmonary arterial hypertension and idiopathic pulmonary fibrosis. Learn about their promising Phase IIa results that showed improved heart function and reduced mortality risk, the FDA fast track designation they recently received, and their strategy for advancing two rare disease programs toward pivotal trials. A fascinating look at drug repurposing, epigenetic modulation, and the challenges of developing therapies for high unmet need patient populations.

Defining the Next Era of Disruption

Tue, 07 Oct 2025 13:32:07 -0000

Listen now as Citeline speaks with top executives from Perceptive to understand eClinical’s major reset and what it means for the future of clinical trials. Learn more about IRT’s evolving role, lessons learned, and how tech will rule the data-driven trials of the future.

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast) Oct.7, 2025

Tue, 07 Oct 2025 02:00:50 -0000

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2025年10月3日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。本次要闻: 辉瑞暗箱操作美国定价协议；日本药品关税政策引发争议；美国直供患者计划持续扩张；诺华瑞美布替尼获首次批准；葛兰素史克首席执行官即将卸任。 https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-NYTAMV4KPFCB3PSCCQMKIF2CEA/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Celebrating Europe’s Consumer Health Best Practice, With AESGP’s Luis Rhodes Baiao

Mon, 06 Oct 2025 08:55:52 -0000

Celebrating Europe’s Consumer Health Best Practice, With AESGP’s Luis Rhodes Baiao The Association of the European Self-Care Industry, or AESGP, has launched a digital platform that brings together inspiring self-care initiatives from across Europe. Launched to coincide with International Self-Care Day 2025, AESGP’s Self-Care Insight and Inspire platform showcases national-level initiatives led or supported by the consumer health industry in collaboration with healthcare professionals, sectoral associations, and public authorities. In this episode of the Over the Counter podcast, AESGP governmental and public affairs manager, Luis Rhodes Baiao, tells HBW Insight about the background behind the platform and pulls out some of his favourite examples. Timestamps 2:00 – Introductions 5:15 – AESGP’s Self-Care Insight and Inspire platform 14:30 – Luis’s favourite examples 17:30 – Public reaction to the campaign 18:50 – Next steps 20:30 – How to get involved Guest Bio Luis Rhodes Baiao is governmental and public affairs Manager at AESGP. Before, he was policy advisor to a Portuguese Member of the European Parliament on the Committee for Environment, Public Health and Food Safety (ENVI), during the mandate 2014 to 2019. He is currently also vice-president of the General Assembly of the Association Public Affairs Portugal (PAPT).

Scrip's Five Must-Know Things - Oct. 6, 2025

Mon, 06 Oct 2025 01:23:44 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended October 3, 2025. In this episode: Pfizer’s backroom US pricing deal; confusion over Japan’s pharma tariffs; more direct-to-patient schemes in the US; first approval for Novartis’s remibrutinib; and GSK’s CEO to step down. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-NYTAMV4KPFCB3PSCCQMKIF2CEA/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Drug Fix: Government Shutdown’s Impact On US FDA, Pfizer Inks Drug Pricing Deal

Fri, 03 Oct 2025 15:41:49 -0000

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, and senior editors Sue Sutter and Cathy Kelly consider the impact of the government shutdown on the US Food and Drug Administration, as well as industry (:21), and discuss the future of drug pricing after Pfizer completes its deal with the White House to embrace its Most Favored Nation plan (10:29). More On These Topics From The Pink Sheet Shutdown Approaches: US FDA Would Retain Most Of Recently Trimmed Staff: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/shutdown-approaches-us-fda-would-retain-most-of-recently-trimmed-staff-DTVAHLBI5VGZBPHD76TLNDIBGU/ Shutdown Day One: US FDA Hiring, MFN Demos Delayed?: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/shutdown-day-one-us-fda-hiring-mfn-demos-delayed-7LGCITF2WVCJNEVUTWZV5MOZSE/ Closing The Gap? Pfizer Will Set Same US, Foreign Launch Prices In MFN Deal: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/closing-the-gap-pfizer-will-set-same-us-foreign-launch-prices-in-mfn-deal-ZRSNU56KTFGRBBX4Y5OJKLFV6Y/ Questions Persist About How Pfizer’s US Agreement Lowers Prices: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/questions-persist-about-how-pfizers-us-agreement-lowers-prices-T2TEWMKVMVHGJHPXDKIFDF2GWA/

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast) Sept.30, 2025

Tue, 30 Sep 2025 03:13:20 -0000

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2025年9月26日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。本期要闻：辉瑞通过收购Metsera重返肥胖治疗领域；罗氏勾勒肥胖治疗战略蓝图；UniQure公司亨廷顿病基因疗法取得积极进展；百时美施贵宝计划在英国采用美国定价策略推广Cobenfy；疫苗质疑情绪影响商业化前景。 https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-HCVAK32IGREDHMH5D4I3RFY6AA/ Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Scrip's Five Must-Know Things - Sept. 30, 2025

Tue, 30 Sep 2025 02:40:02 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended September 26, 2025. In this episode: Pfizer jumps back into obesity with Metsera bid; Roche maps out its obesity ambitions; UniQure’s encouraging gene therapy results for Huntington’s; BMS plans US pricing for Cobenfy in the UK; and vaccine skepticism affects vaccine commercial prospects. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-HCVAK32IGREDHMH5D4I3RFY6AA/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

The Generics Bulletin Podcast: Talking with AAM president and CEO John Murphy

Fri, 26 Sep 2025 16:53:45 -0000

Generics Bulletin editor Dave Wallace talks to John Murphy III, president and CEO of the US Association for Accessible Medicines, about the association's latest annual savings report and key topics affecting the US off-patent market.

3分で解説 #世界のファーマ】第26回欧州の先発医薬品米国関税15％適用へ (Japanese-language podcast) Sept.24, 2025

Wed, 24 Sep 2025 01:47:30 -0000

世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。今回取り上げた記事はこちら「EFPIA Rallies EU To Shield Innovative Drugs After US Tariff Cap Is Confirmed（邦訳：欧州製薬団体、医薬品への米国関税適用に反発　EUへ対策を要請）」 URL:　 https://insights.citeline.com/pink-sheet/compliance/manufacturing/efpia-rallies-eu-to-shield-innovative-drugs-after-us-tariff-cap-is-confirmed-HYZJDK4S7NGT3FUEBA5AFSYYT4/ Playlist: soundcloud.com/citelinesounds/sets/japanese-language-mini

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast) Sept.22, 2025

Mon, 22 Sep 2025 05:06:46 -0000

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2025年9月19日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。本期内容——GSK在特朗普访英期间宣布美国投资计划；礼来公司对英国实验室投资三思而后行；解析中国研发与并购热潮；再生元CEO谈被忽视的重磅产品；阿斯利康COPD试验受挫。 https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-D4VJFG2XNJGAJEFGSXNEQUA3BU/ China Webinar sign up: https://www.citeline.com/en/events/china-transforming-pharma Playlist: https://on.soundcloud.com/gnr7PaOwflNKiAO7QX

Scrip's Five Must-Know Things - September 22, 2025

Mon, 22 Sep 2025 02:51:09 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended September 19, 2025. In this episode: GSK announces US investments during Trump’s UK visit; Lilly thinks twice about UK lab investment; analyzing the rise in China R&D and deals; Regeneron CEO on his company’s ignored blockbusters; and AstraZeneca’s COPD trial failure. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-D4VJFG2XNJGAJEFGSXNEQUA3BU/ Sign up for China R&D webinar: https://www.citeline.com/en/events/china-transforming-pharma This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

ICROM on Innovation in HPAPI & Crystallization

Fri, 19 Sep 2025 11:00:47 -0000

Hear from ICROM CEO Pierfrancesco Morosini and HOLODIAG GM Pierric Marchand as they discuss how the company is advancing HPAPI development, solid-state science, and flexible CDMO services. Topics include OEB5/6 capabilities, a new kilo-scale unit, and the impact of electron diffraction on drug development.

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast) Sept.16, 2025

Tue, 16 Sep 2025 05:56:11 -0000

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2025年9月12日当周的生物制药行业的商业动态。本期要闻——诺和诺德裁员9000人；诺华心脏病业务板块交易焕新；强生Inlexto获批；Summit公司ivonescimab面临挑战；FDA严打直接面向消费者广告。 https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-XQF6667ICBDMTFBCUCNYBZUJZY/ 本期节目采用人工智能文本转语音及语音仿真技术制作。

Scrip's Five Must-Know Things - September 16, 2025

Tue, 16 Sep 2025 03:26:35 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended September 12, 2025. In this episode: Novo Nordisk cuts 9,000 jobs; deals freshen up Novartis’s cardio franchise; J&J’s Inlexto approval; Summit’s ivonescimab challenges; and FDA’s DTC ad crackdown. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-XQF6667ICBDMTFBCUCNYBZUJZY/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Drug Fix: US FDA DTC Ad Crackdown Emerges From MAHA Report

Fri, 12 Sep 2025 16:22:33 -0000

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter, and Editor-in-Chief Nielsen Hobbs look at the potential consequences of the US Food and Drug Administration’s upcoming crack down on direct-to-consumer advertising (:30), including the first publicly released letter, which went to AstraZeneca for a Flumist TV commercial (2:50), as well as vaccine policy and other major issues that were listed in the Make America Healthy Again Commission’s Strategy Report (21:45). More On These Topics From The Pink Sheet Direct-To-Consumer Ads: Manufacturers Face ‘Cease And Desist’ Orders Now, Uncertain Future: https://insights.citeline.com/pink-sheet/compliance/marketing-and-advertising/direct-to-consumer-ads-manufacturers-face-cease-and-desist-orders-now-uncertain-future-6XLXAWS7WJBYNPHSBRAQVTBARU/ Limited Detail In MAHA Strategy Report Could Catch Pharma Off Guard: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/limited-detail-in-maha-strategy-report-could-catch-pharma-off-guard-TVL7CCBQONA7PHCLUDJ7WTEJC4/

Drive Early CRO Engagement to Optimize Funding, Trial Design, and Recruitment in Biotech

Fri, 12 Sep 2025 09:45:31 -0000

What makes a biotech-CRO partnership truly work? Claire Riches, VP, Clinical Solutions, Citeline, and Matt Simmons, Senior Director, Oncology Strategy, IQVIA Biotech, share the secrets behind winning biotech-CRO partnerships, covering collaboration, transparent budgeting, regulatory navigation, and recruitment strategies, with essential insights to help biotechs succeed from their first RFP to global trials. View the video series and find out more information here: https://www.citeline.com/biotech

Why Local Matters: A Leadership Perspective on Community-Based Trials

Tue, 09 Sep 2025 08:50:05 -0000

Community based trials are reshaping clinical research, broadening patient access and accelerating timelines. Discover the drivers, challenges and future outlook.

From Abandonment To Opportunity In Pediatric Pharma

Mon, 08 Sep 2025 13:20:26 -0000

In Vivo spoke with Annette Bakker, CEO of the Children’s Tumor Foundation, a medical research foundation developing an innovative approach to reviving shelved pharmaceutical assets, resulting in the recent US FDA approval of mirdametinib, a treatment for rare tumors.

Scrip's Five Must-Know Things - September 5, 2025

Mon, 08 Sep 2025 01:25:03 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended September 5, 2025. In this episode: the US MASH market after Wegovy’s approval; AstraZeneca and Mineralys in close hypertension race; United Therapeutics’ Phase III win in IPF; Corsera aims to predict and prevent cardiovascular disease; and Ionis’s RNA-targeted win in severe hypertriglyceridemia. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-RKP4E4CFGFGGXBRVXTI73V27U4/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Is It Better To Be A Sustainability ‘Shaper’ Or ‘Staller’? With PA Consulting’s Rhea Patten

Sun, 07 Sep 2025 18:35:52 -0000

For today’s consumers, sustainability is an expectation rather than a luxury, according to PA Consulting’s latest Brand Impact Index. In other words, companies that haven’t invested in minimizing their brands’ impact on the environment are at risk of being left behind. “But it’s ok to get it wrong sometimes too,” notes PA’s personalization and consumer expert, Rhea Patten, in this episode of HBW Insight’s Over the Counter podcast. And maybe for smaller brands, being a staller rather than a shaper may also make strategic, short-term sense, as long as consumers can understand that sustainability is their long-term goal. Don’t mis the first part of this interview with Patten, in which we discussed, among other things, what “vibes” are and how understanding this aspect of “consumer centricity” better can help consumer health companies grow their brands. Timestamps 2:00 – Do consumers still want sustainable brands? 8:00 – Will consumers forgive sustainability missteps? 10:00 – Will consumers pay more for sustainable brands? 13:00 – Is better to be a sustainability shaper or staller? 15:30 – Final thoughts Guest Bio Rhea Patten is a consumer product expert at PA Consulting, with expertise in health, beauty, and wellness. She has over 20 years’ experience in leading innovation and transformation projects in the consumer products and retail sector. Passionate about bridging physical products with digital experiences, Patten helps leaders deliver solutions that drive business growth. She specializes in accelerating product innovation, with a focus on strategy, customer-centricity, and sustainability.

Drug Fix: US FDA Drops Offit, Others From Adcomms, Releases Unapproved Product Rejection Letters

Fri, 05 Sep 2025 16:44:12 -0000

Pink Sheet Executive Editor Derrick Gingery, Managing Editor Bridget Silverman, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the ongoing impact of the US Food and Drug Administration decision to drop vaccine expert Paul Offit and others from its advisory committee rosters (:32), as well as the substantial new detail in the latest batch of complete response letters for unapproved products that the agency released (12:47). More On These Topics From The Pink Sheet Offit’s VRBPAC Departure Raises Questions About Another HHS Panel Revamp: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/breaking-paul-offit-no-longer-member-of-us-fdas-vaccine-advisory-panel-WX3X3CIP6VCARJ7BPLXNQIQ2BQ/ US FDA Compounding Advisory Panel Hit Hardest By Recent Purges: https://insights.citeline.com/pink-sheet/product-reviews/us-advisory-committees/us-fda-compounding-advisory-panel-hit-hardest-by-recent-purges-OXBD4IXGFZCIDIMB6VXSOSVP6U/ 89 Complete Response Letters For Unapproved Drugs, One Huge Leap For US FDA Transparency: https://insights.citeline.com/pink-sheet/product-reviews/complete-response-letters/89-complete-response-letters-one-huge-leap-for-us-fda-transparency-for-unapproved-drugs-SLYA5LADMNDY3LKZ5TRUAWRRAU/

China Biopharma English-Language Podcast: China Innovative Drugs And Commercial Insurance

Tue, 02 Sep 2025 06:29:25 -0000

In this episode of the China Biopharma English-language Podcast, Shanghai-based senior reporter Xu Hu talks about the release for the first time by China’s National Healthcare Security Administration in August of a preliminary list of innovative drugs reimbursed by commercial insurance and the key reasons that have driven this reform. Related story links: https://insights.citeline.com/pink-sheet/geography/asia/china/china-signals-commercial-insurance-biotech-and-foreign-owned-hospitals-as-policy-priorities-6WABWKHO3VCRHNSCOXGABSHTZE/ https://insights.citeline.com/pink-sheet/market-access/government-payers/china-unveils-multiple-policies-to-support-innovative-drugs-throughout-life-cycle-JFEHXBAS2ND3PGJYKOF7NB6ZCM/ https://insights.citeline.com/pink-sheet/geography/asia/china/china-nhsa-releases-preliminary-innovative-drug-list-for-first-time-JOSACB66CZA6BOZNDEGFTLLWSU/

Scrip's Five Must-Know Things - Sept. 1, 2025

Mon, 01 Sep 2025 01:31:27 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended August 29, 2025. In this episode: Lilly’s orforglipron strong in diabetic obesity; Ascletis confident in oral GLP-1 challenger; myostatin drugs progress for obesity; an interview with OneSource’s CEO; and an analysis of Dupixent’s pipeline-in-a-product success. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-KKZ7ZW3B2VGUBFTSLNCLIHU7QU/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Drug Fix: US FDA Changes COVID-19 Vaccine Labeling, Reimbursement Confusion Rises

Fri, 29 Aug 2025 15:50:48 -0000

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Senior Editor Sue Sutter discuss the impact of US Food and Drug Administration’s COVID-19 vaccine indication changes and recission of the associated emergency use authorizations, as well as the postmarketing studies that now are required (:40), and their potential impact on access and reimbursement (12:20). More On These Topics From The Pink Sheet COVID-19 Vaccines: Pfizer Arguments To Keep EUA Failed To Persuade US FDA’s Prasad: https://insights.citeline.com/pink-sheet/vaccines/covid-19-vaccines-pfizer-arguments-to-keep-eua-failed-to-persuade-us-fdas-prasad-V3X2OEBZE5HRHKO7KMMCFXBM2Q/ US FDA Updates COVID-19 Vaccine Formulations, Revokes EUAs, ACIP Use Decision Next: https://insights.citeline.com/pink-sheet/vaccines/us-fda-updates-covid-19-vaccine-formulations-revokes-euas-acip-use-decision-next-VBXJDSOA6BCOXNCA2TAH27EBJY/ A US FDA Move to Revoke Pfizer’s Pediatric COVID-19 Vaccine EUA Could Raise Supply Questions: https://insights.citeline.com/pink-sheet/vaccines/a-us-fda-move-to-revoke-pfizers-pediatric-covid-19-vaccine-eua-could-raise-supply-questions-ZX26DBENHFCOHPBGMPFPQB6REQ/ Changes In Pediatric COVID-19 Vaccine Recommendations Causing Coverage Confusion: https://insights.citeline.com/pink-sheet/vaccines/changes-in-pediatric-covid-19-vaccine-recommendations-causing-coverage-confusion-WDEYUVJXGBCGBEVBQ2I6INH554/

Navigating What’s Next for Global Drug Development: What Sponsors Need to Know

Fri, 29 Aug 2025 13:14:53 -0000

As global regulatory expectations evolve, biotech sponsors face growing pressure to make smarter, earlier decisions about where and how to run their trials. In this episode, Novotech experts Renita Hite (Director of Regulatory Affairs, Drug Development Consulting) and Scott Schliebner (Global Head of Drug Development Consulting) join moderator Meredith Landry to discuss how early-stage sponsors can adapt to shifting FDA initiatives, accelerated global pathways, and increasing demands for regulatory flexibility. They explore: How new FDA initiatives—like AI-driven reviews, user fee changes, and the National Priority Voucher—are reshaping IND strategy Why sponsors should design trials with global data packages in mind from day one Accelerated and early access pathways that can speed startup and market entry How CROs are evolving to help sponsors prioritize markets and build regulatory flexibility If you’re planning trials for 2025 and beyond, this conversation will help you prepare for what’s next—and position your program for long-term success. About This Episode This episode is the final installment (4 of 4) in the series “Navigating Regulatory Changes & Market Dynamics: CRO Perspectives on the Future of Clinical Trials”, featuring insights from Novotech on evolving trends impacting global clinical development. Catch up on earlier episodes: [Part 1: Navigating Regulatory Changes & Market Dynamics] [Part 2: Navigating Regulatory & Market Shifts] [Part 3: Navigating Regulatory Changes & Market Dynamics]

VC가 한발 물러설 때 바이오 기업의 대체 자금원은? (Korean-language podcast)

Fri, 29 Aug 2025 05:40:24 -0000

전통적 벤처캐피털이 점점 더 신중하고 선별적인 투자 성향으로 변하면서 바이오 기업들이 새로운 자본 조달 경로를 모색하고 있다는 Citeline의 In Vivo 기사를 요약한 내용입니다. https://insights.citeline.com/in-vivo/growth/when-vc-steps-back-finding-alternative-biotech-funding-4UN5IYJEUZD2XPLYIZ7RR7YVQY/ Playlist: https://soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini

【3分で解説 #世界のファーマ】第25回中国、民間保険で新薬のアクセス拡大へ

Thu, 28 Aug 2025 07:05:12 -0000

世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。今回取り上げた記事はこちら「China NHSA Releases Preliminary Innovative Drug List For First Time（邦訳：中国国家医療保障局、初の画期的医薬品向け償還“候補”リストを発表）」 URL:　 https://insights.citeline.com/pink-sheet/geography/asia/china/china-nhsa-releases-preliminary-innovative-drug-list-for-first-time-JOSACB66CZA6BOZNDEGFTLLWSU/ ※全文の閲覧には購読（有料）が必要です。世界の製薬ビジネスメディアScrip（スクリップ）とは？ https://www.citeline.com/ja-jp/products-services/commercialization/scrip Playlist: https://soundcloud.com/citelinesounds/sets/japanese-language-mini

How To ‘Vibe’ With Consumers, With PA Consulting’s Rhea Patten

Tue, 26 Aug 2025 05:57:18 -0000

Despite the recent pressure on their finances, consumers are rejecting the idea of choosing brands based on cost alone, according to PA Consulting’s latest Brand Impact Index. People are prepared to pay more for brands they “vibe” with, PA suggests. But what are vibes? And how can consumer health companies tap into them? As PA personalisation and consumer expert Rhea Patten explains in this episode of HBW Insight’s Over the Counter podcast, vibing with consumers means making them feel special, seen and heard, and creating communities around their needs. Timestamps: 2:00 – Introductions 3:00 – The Brand Impact Index 4:30 – This year’s headline findings 6:30 – What OTC firms can learn from leading beauty and wellness brands 17:00 – What are “vibes”? 25:00 – How to build a brand community Guest Bio: Rhea Patten is a consumer product expert at PA Consulting, with expertise in health, beauty, and wellness. She has over 20 years’ experience in leading innovation and transformation projects in the consumer products and retail sector. Passionate about bridging physical products with digital experiences, Patten helps leaders deliver solutions that drive business growth. She specialises in accelerating product innovation, with a focus on strategy, customer-centricity, and sustainability.

Scrip's Five Must-Know Things - August 25, 2025

Mon, 25 Aug 2025 01:22:00 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended August 22, 2025. In this episode: Madrigal regains MASH lead with EU Rezdiffra approval; Viking’s obesity data scare investors; China assets lead GLP-1 deals; CSL and others restructure; and Indegene exec on DTP and MFN policies. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-T77LV22VANAL5GNPCC2YUVLZBE/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Merck KGaA's Vision For Making Digital Health Redundant

Fri, 22 Aug 2025 12:46:06 -0000

Merck KGaA's Emre Ozcan outlines the company's systematic approach to integrating digital solutions across the care continuum in specialty pharmaceuticals, moving from technology-first to patient-need-first strategies.

Tevard CEO Sees Hope for HIs Daughter In His Company's tRNA Platform

Mon, 18 Aug 2025 16:24:06 -0000

Tevard Biosciences CEO Daniel Fischer discusses how engineered suppressor tRNAs enable read-through of premature stop codons to restore full-length protein production in genetic diseases. Fischer, whose daughter has Dravet syndrome, covers the company's lead programs in dilated cardiomyopathy and DMD, advantages over traditional gene therapy approaches, and the path to human proof-of-concept.

Scrip's Five Must-Know Things - August 15, 2025

Mon, 18 Aug 2025 01:30:54 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended August 15, 2025. In this episode: a look at the likely top drugs in 2030; Lilly CEO advocates US/Europe pricing rebalance; Insmed sees $5bn-plus market for Brinsupri; royalty deals go mainstream; Phase III win sets stage for Epkinly label expansion. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-365OXHOS2RFXHPEDQIURY6LFDI/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Scrip's Five Must-Know Things - August 8, 2025

Tue, 12 Aug 2025 01:56:19 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended August 8, 2025. In this episode: Trump ups pressure on MFN pricing; Pfizer says pharma working with Trump on direct sales; Sanofi says direct sales worth considering: Aurigene Oncology CEO on biotech valuations and more; and Novartis progresses pipeline-in-a-product assets. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-RCXSH2B5EVCC3IIK35GXUSNZVA/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Turning Global Ambition Into Local Reality, With Haleon’s Jo Cooper

Mon, 11 Aug 2025 00:31:10 -0000

It’s been about three years since Haleon became a standalone self-care company. Since then, the firm has announced an ambitious plan to reach one billion more consumers by 2030. In this episode of HBW Insight’s Over the Counter podcast, we catch up with Haleon’s new UK & Ireland general manager Jo Cooper to find out what that means in practice when translated to the firm’s home market. Empowering pharmacists is key to Cooper’s local plans, as is exploring the opportunities suggested by the UK government’s recently published list of Rx-to-OTC switches it would like to see applications for. Timestamps 2:00 – Introductions 4:00 – Becoming consumer focused 10:00 – Attracting talent into consumer health 13:00 – Translating Haleon’s ambitious global growth strategy to a local context 25:00 – The importance of pharmacy 30:00 – Rx-to-OTC switch and Haleon’s R&D strategy 38:00 – Unpacking Haleon’s “strategic category realignment

Aurigene Oncology CEO On Biotech Valuations, CAR-Ts And Reimbursement Models

Tue, 05 Aug 2025 05:45:28 -0000

Dr Murali Ramachandra, CEO of Aurigene Oncology, talks to Anju Ghangurde about the tough biotech funding environment, promising pipeline assets including a CAR-T cell therapy in Phase II and ‘hybrid’ manufacturing options, besides outcome-based reimbursement models. The promise of bispecifics and multispecifics in oncology, including Chinese biotech Akeso’s PD-1/VEGF bispecific antibody, are some of the other topics he discussed.

Poolbeg CEO On The Biotech’s Big Bet On Small Molecules

Mon, 04 Aug 2025 15:39:31 -0000

In the latest episode of the In Vivo Podcast, Jeremy Skillington, CEO of Poolbeg Pharma, discussed the company’s ambitious pipeline and strategic direction.

Scrip's Five Must-Know Things - August 4, 2025

Mon, 04 Aug 2025 02:09:08 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended August 1, 2025. In this episode: EU tariff deal leaves questions for pharma; Prasad’s CBER exit could bode well for genetic medicines; Winrevair grows but Merck & Co. plans cost cuts; Novo Nordisk selects new CEO; and a look at obesity past the GLP-1s. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-AOJAANRHLNCPNNLNGVVKA3HEAE/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Exploring Ex-US Markets to Reduce Risk for Your Clinical Trials

Fri, 01 Aug 2025 10:36:58 -0000

Amid growing uncertainty in the U.S. regulatory landscape, sponsors are increasingly looking to ex-U.S. markets as a strategic way to reduce clinical trial risk and maintain momentum. In this episode, Novotech experts Renita Hite and Scott Schliebner discuss how biotech and small to mid-sized pharma companies are adapting their global trial strategies—leveraging regions like APAC and Eastern Europe for faster startups, strong data quality, and significant cost savings. They explore: -Why sponsors are increasingly looking outside the U.S. amid regulatory and political uncertainty -Key benefits of ex-U.S. regions like APAC and Eastern Europe, including speed, quality, and cost savings -Strategic considerations for integrating global sites into clinical development plans -Common pitfalls and risk mitigation strategies when operating in international markets -How ex-U.S. trials support greater flexibility and resilience heading into 2025–2026 This episode is part 3 of 4 in the series “Navigating Regulatory Changes & Market Dynamics: CRO Perspectives on the Future of Clinical Trials”, featuring insights from Novotech on evolving trends impacting global clinical development. Stay tuned for the next episode, where we’ll continue exploring the key forces shaping the future of clinical trials. Listen to part 1 here: Podcast Series: Navigating Regulatory Changes & Market Dynamics: CRO Perspectives on the Future of Clinical Trials Listen to part 2 here: Podcast Series: Navigating Regulatory & Market Shifts — CRO Perspectives on Clinical Trials

The Patient Journey: Key R&D Considerations In Rheumatoid Arthritis

Tue, 29 Jul 2025 12:52:12 -0000

Listen to learn more about the evolving landscape of rheumatoid arthritis treatment through the lens of the patient experience. One RA patient shares her insights as Advanced Clinical discusses the results from a recent RA patient experience survey.

Seizing The Healthy Aging Opportunity, With Prime Fifty’s Max Gowland

Tue, 29 Jul 2025 03:57:12 -0000

Healthy aging has been identified as an important trend that consumer healthcare companies need to respond to. According to founder and managing director of UK firm Prime Fifty, Max Gowland, innovating in this area requires understanding the science behind healthy aging and offering consumers specific and efficacious products, rather than catch-all solutions. In this episode of HBW Insight’s Over the Counter podcast, Gowland dives into some of the science behind targeted nutrition for over fifties and explains why appearing on TV shopping channels like QVC has offered a useful way to communicate these benefits to older consumers. Timestamps: 2:00 – Introductions 5:45 – Leveraging consumer health industry experience 8:15 – Prevention is key 10:30 – Competing for shelf space 13:30 – Be a specialist not a generalist 14:30 – Selling via shopping TV 17:30 – Why science and quality is important in healthy aging supplementation 24:00 – Addressing musculoskeletal health 32:00 – Getting your claims right 36:00 – What’s next for Prime Fifty Guest Bio: Max Gowland is a PhD-qualified biochemist with over 40 years’ experience in health and nutrition. He is a leading expert on shaping the nation on providing supplements for 50+ and his focus includes helping support longevity through supplementation to support bone health, skin, hair, nails and more. Having worked with many large companies, Gowland founded Prime Fifty focusing on healthy ageing and currently serves as Chief Scientific Officer at FutureYou Cambridge. Gowland regularly appears on QVC and at industry events to promote evidence-based nutritional support for midlife and beyond.

Scrip's Five Must-Know Things - July 28, 2025

Mon, 28 Jul 2025 03:33:32 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended July 25, 2025. In this episode: Sanofi’s Vicebio buy; Sarepta halts US Elevidys shipments; Novartis warning over Europe; US CRL for Genentech’s Columvi; and an interview with Novavax. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-U4IN5X7DRVFLVIBJ4Q72VTAJUY/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Drug Fix: US FDA’s New Top Drug Regulator, Sarepta’s Options After Elevidys Stand-Off

Fri, 25 Jul 2025 17:27:41 -0000

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Editor-in-Chief Nielsen Hobbs discuss the issues awaiting George Tidmarsh, the new director of the US Food and Drug Administration’s Center for Drug Evaluation and Research (:24), as well as the next steps for the agency and Sarepta amid the ongoing problems with its gene therapy Elevidys (delandistrogene moxeparvovec) (23:49). More On These Topics From The Pink Sheet Will Tidmarsh’s Industry Experience Translate As US FDA’s Chief Drug Regulator?: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/breaking-news-pharma-ceo-george-tidmarsh-named-director-of-us-fdas-drug-center-2HXJJCPAIVB2RFNGDDU5NZVNQQ/ Business Background Of New CDER Director George Tidmarsh: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/business-background-of-new-cder-director-george-tidmarsh-BROCYQDUYFE3LIQDJ2JNBDWD6Y/ US FDA Cancer Reviewers Heading For The Exits, Potentially Impacting Review Timelines: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-cancer-reviewers-heading-for-the-exits-potentially-impacting-review-timelines-YMOFTXDFDZBGVGBIKFXHJY5XTY/ US FDA’s Biologics Center Departures Grew Before More Than 100 RIFs Exited: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-biologics-center-departures-grew-before-more-than-100-rifs-exited-2LR3ZFYOBND3DLIWXSFFWWLFYE/ After Sarepta Reversed Course On Elevidys, Could An Adcomm Be Next?: https://insights.citeline.com/pink-sheet/product-reviews/post-marketing-regulation-and-studies/after-sarepta-reversed-course-on-elevidys-could-an-adcomm-be-next-ZA5ODQB3DJF4LBDFODMB52DM3M/ Sarepta Refuses To Stop Elevidys Shipments After Third Death Linked To Gene Therapy Vector: https://insights.citeline.com/pink-sheet/advanced-technologies/cell-and-gene-therapies/us-fda-asks-sarepta-to-stop-elevidys-shipments-after-third-death-linked-to-gene-therapy-vector-GLJ2YJDJGNBPLD3SSKKE6UVM34/

MoonLake Leaders On Its Fast-Track Vision And $500m Deal

Wed, 23 Jul 2025 12:17:48 -0000

MoonLake Immunotherapeutics is racing ahead in the biotech space with its innovative nanobody SLK and a transformative $500m non-dilutive financing deal. Its CEO and CFO discuss with In Vivo the company’s rapid clinical progress, financial strategy and ambitions to reshape inflammatory disease.

Scrip's Five Must-Know Things - July 22, 2025

Tue, 22 Jul 2025 02:29:41 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended July 18, 2025. In this episode: – J&J delivers in Q2 despite Stelara drop; Sarepta cuts jobs as Elevidys slumps; AI is inevitable but needs to be applied appropriately; China’s mid-cap companies thrive; and a look behind Glenmark’s landmark trispecific deal. Article links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-HYQOHZ42CNCQRPF6HCKGLTHUKM/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Scrip M&A Podcast: Is Biopharma M&A In A Holding Pattern Or A ‘New Normal’

Mon, 21 Jul 2025 21:01:43 -0000

Scrip discusses the latest M&A activity and trends with CEO Shawn Titcomb of Allele Capital and Cheryl Reicin, a partner focused on international life sciences activity at Mintz.

Drug Fix: CBER Director’s Political Spin On COVID-19 Vaccines And US FDA RIFs Finalized

Fri, 18 Jul 2025 17:38:04 -0000

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss why Center for Biologics Evaluation and Research Director Vinay Prasad cited an unproven theory alleging politics influenced the 2020 COVID-19 vaccine emergency use authorizations to justify his decision to overrule reviewers on more recent indication updates (:35). They also consider the impact of hundreds of staff departures after the US Food and Drug Administration’s reduction-in-force was allowed to proceed, including 600 in the Center for Drug Evaluation and Research (20:14). More On These Topics From The Pink Sheet Prasad Cites Unproven Theory Defending His COVID-19 Vaccine Decisions: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/prasad-cites-unproven-theory-defending-his-covid-19-vaccine-decisions-QFAGD35QOFA5VCZS4WXDPCNWV4/ US FDA’s Drugs Center Lost Hundreds Of Staff Through June With 600 RIFs Coming: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-drugs-center-lost-hundreds-of-staff-through-june-with-600-rifs-coming-GYSWOX6RIZEXTK5LZ4KWF3PPDY/

Strategic Insights into the RNA Market

Thu, 17 Jul 2025 15:23:37 -0000

Join Meredith Landry, Managing Editor of Citeline’s Custom Content, in conversation with Tom Hickey, Director of Therapeutic Strategy at Novotech, a global full-service clinical CRO dedicated to accelerating the development of advanced and novel therapeutics. In this episode, recorded at the annual BIO conference in Boston, Tom offers a sharp and timely look at the state of RNA therapeutics and shares how innovation in delivery technologies, regulatory strategy, and partnership models is shaping the next generation of RNA-based medicines. With Novotech’s deep experience in the space, Tom provides actionable insights for biotech leaders looking to position their RNA programs for long-term success.

Digital Health Roundup: Autonomous Robots, Medtronic’s Surgeon School, Sleep Tech & FDA Rules

Wed, 16 Jul 2025 21:28:03 -0000

In this week's Digital Health Roundup, MedTech Insight's Marion Webb discusses her interview with Johns Hopkins researcher Axel Krieger who published study findings on autonomous surgery. Brian Bossetta highlights new FDA cybersecurity guidance and Medtronic's partnership with IRCAD to train surgeons on robots. Shubham Singh highlights his interviews with OpenWater on stroke and EnsoData on sleep. Natasha Barrow discusses FDA approval challenges with Flow Neuroscience's CEO. Tags: robotics, robotic surgery, FDA, cybersecurity, cardiology, neurology, leadership interviews, neurostimulation, commercial, medtech.

“They Are Able To Keep Their Body”: Medipost On Its Stem Cell Therapy Vision

Wed, 16 Jul 2025 15:33:51 -0000

The latest episode of the In Vivo podcast features an interview Edward Ahn, CEO of Medipost, a Korean company that has developed stem cell therapies from cord blood, on how they are working across regulatory markets to provide a novel treatment for degenerative diseases.

Astellas Doubles Down on Gene Therapy Despite Industry Headwinds

Tue, 15 Jul 2025 15:00:35 -0000

Astellas is doubling down on gene therapy while others retreat. Richard Wilson, SVP Primary Focus Lead, Genetic Regulation at Astellas, joins In Vivo to discuss why the company believes AAV technology will transform medicine despite current industry headwinds. 🎯 Key Topics: - Why Astellas opened a massive new gene therapy manufacturing facility - Building an end-to-end AAV platform from research to commercial - Strategic partnerships driving CNS and rare disease programs - Maintaining team morale in a challenging investment climate - Regulatory outlook and the path to commercial success Richard also plays a role in Astellas' West Coast Innovation Center and serves on the Alliance for Regenerative Medicine board. He shares insights on manufacturing at scale, patient-centric culture, and the long-term potential of gene therapy. Perfect for biotech investors, pharma executives, and anyone tracking the evolution of genetic medicines. 🔗 More insights: insights.citeline.com/in-vivo

Scrip's Five Must-Know Things - July 14, 2025

Mon, 14 Jul 2025 02:06:10 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended July 11, 2025. In this episode: Merck & Co’s Verona acquisition; venture funding plummets in Q2; how Teva is expanding innovation; Apogee’s Phase II eczema win; and a look at India’s wave of licensing. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-TJX4YBGD5JDSHGRUTLYHWO2JMU/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Seizing The GLP-1 Wellness Opportunity, With Kerry Group’s Mathieu Millette

Mon, 14 Jul 2025 01:15:18 -0000

Originally developed to treat diabetes, GLP-1 agonists have been found to suppress appetite and reduce calorie intake, fueling their growing popularity as obesity drugs. According to JP Morgan, the total number of GLP-1 users in the US may reach 30m by 2030, or around 9% of the population. But what is the opportunity for the consumer health industry? According to Kerry Group’s scientific director Mathieu Millette, there are two main areas that companies could target. Firstly, there are the pre-and post-GLP phases, when consumers may want natural GLP-1 alternatives to help them lose weight or maintain the weight loss achieved on the drug. And secondly, during use, consumer health products can help address some of the unwanted side-effects of GLP-1s, for example gastrointestinal issues. Of course, as Millette tells HBW insight in this episode of the Over the Counter podcast, marketers also need to be mindful of the regulatory environment around health claims, especially in the EU. Timestamps 2:20 – Introductions 3:30 – What are GLP-1 agonists? 8:50 – What’s the opportunity for consumer health companies? 16:00 – Is this a European trend as well? 17:40 – Health claims: the regulatory environment 25:00 – Natural GLP-1 alternatives Guest Bio Mathieu Millette is scientific director for Bio-K Plus International and RDA director for digestive health within Kerry Group’s proactive health division. Millette leads a team of talented scientists dedicated to elucidating the mechanisms of action of probiotics and to understanding the interactions between beneficial microorganisms, the gut microbiome, and the gastrointestinal tract. Millette is also associate professor at INRS-IAF, a member of the Association of Microbiologists of Quebec and is highly involved with the International Probiotic Association.

바이오 USA: 금융 시장 스트레스, 딜메이킹 기회 창출 (Korean-language podcast)

Fri, 11 Jul 2025 02:45:54 -0000

올해 제약바이오 M&A 가 다소 주춤할 것으로 전망되고 있지만, 재정난을 겪고 있는 의약품 개발업체들이 자금조달의 대안을 찾으면서 잠재적 매물이 넘쳐나고 있다는 Scrip의 BIO USA 기사를 요약한 내용입니다. https://insights.citeline.com/scrip/conferences/bio/bio-deal-trends-financial-market-stress-creates-transactional-opportunities-IL5W6U4BSZD6RPQ53EHG7HNTJ4/ Playlist: soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini

Phil L'Huillier, Scancell CEO, on the Latest Developments in Cancer Vaccines

Wed, 09 Jul 2025 12:47:13 -0000

The latest episode of the In Vivo podcast features an interview with Phil L'Huillier, who discusses the inclusion of Scancell's melanoma cancer vaccine on the NHS Cancer Vaccine Launch Pad, and how 2025 could be a pivotal year for the cancer vaccine field as a whole.

Acuitas CSO on CRISPR Delivery Breakthrough and Innovations in Lipid Nanoparticles

Mon, 07 Jul 2025 13:51:53 -0000

Ying Tam, Chief Scientific Officer at Acuitas Therapeutics, discusses the company's role in delivering the first personalized CRISPR gene editing treatment to an infant with CPS-1, achieving treatment in just six months from diagnosis. Tam shares insights on evolving lipid nanoparticle technology beyond COVID vaccines, including LNPs that allow for next-generation immune-targeting delivery that is 10x more potent, and progress in delivering genetic medicines to stem cells and solid tumors. He also addresses the challenges of repeat dosing, a new biodegradable LNP formulation, and expanding genetic medicine beyond the liver to treat blood disorders and cancer.

Oxolife’s Agnés Arbat, Winner Of The European Prize For Women Innovators

Mon, 07 Jul 2025 12:37:21 -0000

The latest episode of the In Vivo podcast features an conversation with Agnès Arbat, CEO and co-founder of Barcelona-based biotech company OxoLife, which is pioneering a novel approach to addressing female infertility.

How To Balance Access And Equity In Self-Care, With Bayer’s Emese Csoke

Mon, 07 Jul 2025 06:10:49 -0000

According to a recently published study by Bayer Consumer Health, being poor makes it more likely that you will suffer from self-treatable health conditions. But it also means you will find it harder to take advantage of self-care solutions. In this episode of the Over the Counter podcast, HBW Insight speaks to Bayer Consumer Health’s global medical access lead Emese Csoke about the issues that the study raises for the self-care industry, not least how widening access to self-care solutions can be balanced with equity with regards to affordability. For Csoke, ways forward include partnerships between public and private sector stakeholders and investments in digital self-care. Timestamps 2:00 – Introductions 2:50 – Bayer Consumer Health’s RISE initiative 4:00 – Self-care is hardest for those who need it most 5:45 – Implications for the consumer health industry 8:20 – Self-care’s “double burden” 10:15 – Profit vs people? 16:30 – Public-private partnerships 19:00 – Digital self-care 22:40 – Impact of RISE so far Guest Bio Emese Csoke is currently serving as global strategy director for regulatory, medical, safety, quality, and compliance at Bayer Consumer Health. In this role, she plays a pivotal part in advancing health equity by designing and implementing strategic initiatives that expand access to self-care. Emese led the creation of the strategic pillar RISE – the Research Initiative for Self-care Equity – and authored a peer-reviewed publication on the impact of socioeconomic determinants on health outcomes for self-care conditions. As a lead on Bayer’s “dynamic shared ownership” model, Csoke is also driving force behind organizational transformation and innovation. Csoke holds a PharmD and a degree in Clinical Development Science from Semmelweis University and is certified as a medical science translator.

Scrip's Five Must-Know Things - July 7, 2025

Mon, 07 Jul 2025 02:18:43 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended July 4, 2025. In this episode: AbbVie’s big autoimmune CAR-T play; In Vivo CAR-T interest grows; China deal perspectives from BIO; global pharma interest in Korea undeterred; and a look at the biggest drug sales disappointments. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-Y77FXMFAIFEVFK75G5QUSNSBOY/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

【3分で解説世界のファーマ】第24回トランプ関税製薬大国インドへの影響 (Japanese-language podcast)

Thu, 03 Jul 2025 00:09:48 -0000

世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。今回取り上げた記事はこちら Snapshot Of India’s Pharma Manufacturing Network Amid ‘Trumponomics’（邦訳：インド、医薬品製造ネットワークの現在地　「トランプ経済政策」の最中で） https://insights.citeline.com/scrip/focus-on-asia/india/snapshot-of-indias-pharma-manufacturing-network-amid-trumponomics-4NDNAVYZW5CPZIKDIZHDRXCJ6A/ ※全文の閲覧には購読（有料）が必要です。世界の製薬ビジネスメディアScrip（スクリップ）とは？ https://www.citeline.com/ja-jp/products-services/commercialization/scrip

ADDF's Karen Harris: Investing in Alzheimer's Like a VC

Wed, 02 Jul 2025 12:14:47 -0000

How is venture philanthropy revolutionizing Alzheimer's drug discovery? We sit down with Karen Harris, CFO at the Alzheimer's Drug Discovery Foundation, to explore their game-changing approach to funding early-stage research. With $370M+ awarded to 765+ programs globally, the ADDF operates like a VC firm—using convertible debt and preferred equity to accelerate breakthrough treatments. Topics: Venture philanthropy vs traditional grants Shift from amyloid to combination therapies Blood-based biomarkers & precision medicine NIH funding cuts impact on research ecosystem Karen brings 20+ years investment banking experience to discuss how strategic capital is changing Alzheimer's research.

China Biopharma English-Language Podcast: Obesity Drugs Not All About Weight Loss

Wed, 02 Jul 2025 06:29:12 -0000

In the first episode of this new China Biopharma English-language mini podcast, Shanghai-based senior reporter Xu Hu looks at the main directions in which obesity drug developers are moving, Chinese pharma firms’ position in the global race for muscle-preserving weight loss drugs and China's challenge in matching accessible drugs with well-guided weight loss. Related story links: https://insights.citeline.com/scrip/r-and-d/chinese-developers-showcase-potentially-differentiated-weight-loss-assets-at-ada-TGCGQMCVBFHS7LNTWM6YDPEC3I/; https://insights.citeline.com/in-vivo/global-vision/chinese-firms-build-obesity-clinical-pipeline-but-face-wider-hurdles-KX5GZJDC2NGKRDO6VUU7HROF4Y/

Datamonitor Healthcare Podcast: ASCO 2025

Mon, 30 Jun 2025 15:19:12 -0000

Summer Colling and Emma Wille speak with oncology experts Nkiru Ibeanu, Neha Anand, Anna Simmons and David Dahan about the 2025 American Society of Clinical Oncology (ASCO) conference. Deeper coverage is available through Datamonitor Healthcare

Master Regulatory Hurdles and Accelerate Your Drug Development

Mon, 30 Jun 2025 08:33:09 -0000

With growing FDA bottlenecks and regulatory changes, this episode explores how biotechs are looking beyond borders by rethinking trials, embracing real-world data, and finding new global pathways to bring therapies to life. Small Biotechs, Big Decisions is a limited podcast series exploring the challenges and opportunities facing emerging biotech companies, hosted by Daniel Chancellor, VP of Thought Leadership at Norstella, and Claire Riches, VP of Clinical Solutions at Citeline, a leading provider of life sciences data and insights. View the video series and find out more information here: https://www.citeline.com/biotech

Scrip's Five Must-Know Things - June 30, 2025

Mon, 30 Jun 2025 00:45:42 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended June 27, 2025. In this episode: top drugs in the first quarter; deal trends at bio; Novo and Lilly’s obesity segmentation plans; Chinese firms at ADA; and five drugs that surpassed sales expectations. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-H57S2YTFQRBOLACVOV5SLXWK3Y/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Post-BIO Podcast: Thoughts From The Frontlines

Thu, 26 Jun 2025 03:15:31 -0000

Join Scrip editors Mandy Jackson and Mary Jo Laffler and Pink Sheet editor Sarah Karlin-Smith as they discuss the general mood at the recent BIO International Convention in Boston and around the current US economic and biopharma policy environment in general, along with other key topics at BIO including vaccines, deal and financing and the rise of China's innovation. https://insights.citeline.com/scrip/conferences/bio/post-bio-podcast-thoughts-from-the-frontlines-ID7TBPASUFG4HKFSH56TK44DUM/ https://insights.citeline.com/pink-sheet/conferences/bio/post-bio-podcast-thoughts-from-the-frontlines-VGDKPJ2QQRBV5B6TY36ROPKE4Q/ Time stamps (0:45) Economic and policy environment in the US (2:50) BIO leadership surprisingly open about the industry’s challenges, and willingness to call out Trump government (4:20) Most-favored nation policy proposal: storm in a teacup or existential threat (7:57) DTC sales: new opportunities to sidestep middlemen? GLP-1s leading the way (10:52) Impact of FDA staff cuts and changes on regulatory practices and policy, and on biopharma companies (16:47) Reaction of vaccine companies, health providers, insurers and other stakeholders to ACIP panel dismissal and policy uncertainty (22:27) Climate for biopharma dealmaking and financing; demand for assets (27:28) Advice for startups in challenging times (29:49) China’s biopharma industry in the ascendant (33:27) Rare diseases policy, regulation and industry focus (38:15) Priorities for BIO

Navigating Regulatory Uncertainty: Diversity Action Plans

Tue, 24 Jun 2025 17:07:40 -0000

The FDA’s Diversity Action Plan guidance underwent several changes in recent months—with the draft guidance taken down, restored, and then pulled again—creating uncertainty for sponsors planning Phase III and pivotal trials across all therapeutic areas. With the final guidance expected by June 26, CRO regulatory leaders reflected on how companies can manage this evolving environment. They explored: The impact of the FDA’s changing Diversity Action Plan guidance on sponsors’ trial planning How companies adapted strategies to maintain inclusivity goals amid shifting regulatory priorities Broader implications for trial design, pipeline strategies, and sponsor approaches in the global drug development landscape This episode is part 2 of 4 in the series “Navigating Regulatory Changes & Market Dynamics: CRO Perspectives on the Future of Clinical Trials”, featuring insights from Novotech on evolving trends impacting global clinical development. Stay tuned for the next episode, where we’ll continue exploring the key forces shaping the future of clinical trials. Listen to part 1 here: https://insights.citeline.com/scrip/partnered-content/podcast-series-navigating-regulatory-changes-market-dynamics-cro-perspectives-on-the-future-of-clinical-trials-26Q4Q35N6BHTZGLHIKHK6V2NXY/

How to Crush Competitive Threats and Stand Out in Biotech

Mon, 23 Jun 2025 13:05:49 -0000

The race for new therapies is more intense than ever. This episode uncovers how biotech and pharma use competitive intelligence, AI, and data to outsmart rivals and change the game. Small Biotechs, Big Decisions is a limited podcast series exploring the challenges and opportunities facing emerging biotech companies, hosted by Daniel Chancellor, VP of Thought Leadership at Norstella, and Claire Riches, VP of Clinical Solutions at Citeline, a leading provider of life sciences data and insights. View the video series and find out more information here: https://www.citeline.com/biotech

Scrip's Five Must-Know Things - June 23, 2025

Mon, 23 Jun 2025 01:42:23 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended June 20, 2025. In this episode: US policies in spotlight at BIO; Lilly’s Verve acquisition; UroGen’s bladder cancer approval; Ireland’s biopharma talent; and Korea proposes new AI R&D project. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-VYWYRS37HJH6HNRZJHNGCWVSNM/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

유럽 바이오기업, 자금조달의 현주소는? (Korean-language podcast)

Tue, 17 Jun 2025 04:27:47 -0000

관세와 무역 장벽의 출현, 정책 변화 등으로 올해 유럽 바이오기업들의 자금조달이 쉽지 않은 상황이라는 In Vivo 기사를 요약한 내용입니다. https://insights.citeline.com/in-vivo/market-intelligence/the-360-degrees-of-european-biotech-financing-in-2025-KZUNCOS3GZAYLBPGFTLJUBY7SY/ Join Seoul-based Scrip and Pink Sheet editor Jung Won Shin in this Korean-language mini podcast on recent biopharma industry topics. Playlist: soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini

Brain+ CEO Discusses “Groundbreaking” Potential Of CST Assistant For Dementia Patients

Mon, 16 Jun 2025 13:12:27 -0000

Devika Wood, CEO of Brain+, explains the importance of developing health tech solutions for dementia and the growing need to both raise awareness and improve overall access to nondrug interventions like CST.

Unpacking EU Omnibus And Its Impact On Sustainability: With CEN Group’s Jasper Crone

Mon, 16 Jun 2025 04:20:43 -0000

The European Commission has put forward a series of proposals designed to simplify European Union sustainability rules and boost the region’s competitiveness. As a result, application dates for EU due diligence and sustainability reporting requirements have been delayed by two years. Other proposals such as reducing the frequency of reporting and narrowing the scope of supply chains are still subject to trilogue negotiation. In the first of two Over the Counter episodes, CEN Group director Jasper Crone returns to the podcast to explain what might change, where he thinks this is all coming from and why companies should consider getting ready for new sustainability reporting rules even if they are no longer directly affected. Timestamps: 2:00 – Introductions 4:30 – EU sustainability reporting regulation recap 7:20 – Omnibus simplification package 12:00 – Simplification, or confusion? 19:00 – Where’s this all coming from? 23:30 – Why sustainability reporting is still good for business 25:40 – What’s all this got to do with competitiveness? Guest Bio: Jasper Crone is a Director at CEN-ESG, a corporate sustainability consultancy which helps businesses maximise their corporate sustainability potential, improving performance and ESG disclosure. Crone leads on several client teams, covering the implementation of internal controls and sustainability data, setting sustainability and net zero targets and developing programmes for implementation and operationalisation of objectives. He is experienced in sustainability reporting and the CEN-ESG assists clients with all aspects of sustainability reporting, whether regulatory, investor or customer driven. He brings a range of skills from 20 years of experience in the financial markets, in both the investment banking and investment management industries. He has a BSc in Biology from University of Bristol and is a CFA charter holder. You can contact Jasper via email: jasper@cen-esg.com

Scrip's Five Must-Know Things - 16 June 2025

Mon, 16 Jun 2025 01:42:18 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 13 June 2025. In this episode: breaking down big pharma’s executive pay; US vaccine panel upheaval; Merck’s RSV approval; MFN and Japan; and the future of Pfizer and Arvinas’s partnership. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-BC44NPMNMNGMXP5X4STR4ZAFU4/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Drug Fix: The US and Ex-US Impact Of Most-Favored Nation Drug Pricing

Fri, 13 Jun 2025 15:17:52 -0000

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Francesca Bruce, Senior Editor Cathy Kelly and Editor-in-Chief Nielsen Hobbs consider European officials’ opinions of President Trump’s Most Favored Nation drug pricing proposal (:29), the uncertainty the plan has created and could create for the pharmaceutical industry (22:48), as well as its potential impact on the both sides of the Atlantic Ocean (27:42). More On These Topics From The Pink Sheet ‘Brainless’ US MFN Policy Could Drive Pharma Investment To Europe: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/brainless-us-mfn-policy-could-drive-pharma-investment-to-europe-Z3FC7WBPKNF2LLG4YVZK3RBDUA/ US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany: https://insights.citeline.com/pink-sheet/geography/europe/us-most-favored-nation-pricing-could-be-game-changer-for-drug-access-in-germany-XFXD72XUSBE7VNLRMRSRQQGU5Q/ US Most Favored Nations Policy: Higher Drug Spending In Germany Is ‘Difficult To Imagine’: https://insights.citeline.com/pink-sheet/geography/europe/us-most-favored-nations-policy-higher-drug-spending-in-germany-is-difficult-to-imagine-QYQGDAMNH5A3HK4YWHUYFJCWME/ Could EU Collective Procurement Counter US Most Favored Nation Policy?: https://insights.citeline.com/pink-sheet/could-eu-collective-procurement-counter-us-most-favored-nation-policy-WPQOHPWQ3NF55NYDKT5KMU7AEY/ US ‘Most Favored Nations’ Drug Pricing Policy Will Jeopardize Innovation In Europe: https://insights.citeline.com/pink-sheet/us-most-favored-nations-drug-pricing-policy-will-jeopardize-innovation-in-europe-TR52C5V6GVDSJBOTCEJ7T74FB4/ New Pricing Agreements And Greater Transparency: What A US MFN Policy Could Mean For France: https://insights.citeline.com/pink-sheet/risk-sharing-agreements-greater-transparency-in-pricing-what-us-most-favored-nations-policy-could-OYEHJIF6LJCQZDL6VJHATV77JA/ Crisis Or Opportunity? US MFN Policy Could Test Japan’s Appetite For Reforms: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/crisis-or-opportunity-us-mfn-policy-could-test-japans-appetite-for-reforms-3OTVRHXSOFFIJARSNHPWZ7SBJ4/

Citeline Japan Awards 2025 - Entry Deadline Approaching! (Bilingual English/Japanese)

Thu, 12 Jun 2025 02:53:06 -0000

The 14 July entry deadline for the Citeline Japan Awards 2025 in Tokyo on 21 October is fast approaching! Join Ian Haydock and Lisa Takagi in this bilingual mini podcast as they outline the event and the various Award categories. (Japanese starts at 2:20.) More information on categories, entry criteria, table bookings and sponsorship opportunities here: English: https://www.citeline.com/en/awards/citelinejapanawards) Japanese: https://www.citeline.com/ja-jp/awards/citelinejapanawards)

Strategies to Secure Critical Biotech Funding Amid Market Challenges

Wed, 11 Jun 2025 16:24:49 -0000

Biotechs are racing to change the rules in this tough market. This episode reveals how AI, real-world data, and strategic partnerships are reshaping drug development. Is reinvention biotech’s last hope? Small Biotechs, Big Decisions is a limited podcast series exploring the challenges and opportunities facing emerging biotech companies, hosted by Daniel Chancellor, VP of Thought Leadership at Norstella, and Claire Riches, VP of Clinical Solutions at Citeline, a leading provider of life sciences data and insights. View the video series and find out more information here: https://www.citeline.com/biotech

How to Survive Innovation Pressure in Today’s Biotech Landscape

Wed, 11 Jun 2025 16:14:29 -0000

Small biotech companies are facing tough times, shrinking funding and uncertain futures. But beneath the surface, quiet forces of innovation and resilience are rising. This episode explores how biotechs ignite innovation despite economic headwinds, regulatory uncertainty, and fierce competition. Small Biotechs, Big Decisions is a limited podcast series exploring the challenges and opportunities facing emerging biotech companies, hosted by Daniel Chancellor, VP of Thought Leadership at Norstella, and Claire Riches, VP of Clinical Solutions at Citeline, a leading provider of life sciences data and insights. View the video series and find out more information here: https://www.citeline.com/biotech

Scrip's Five Must-Know Things - 9 June 2025

Mon, 09 Jun 2025 01:36:09 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 6 June 2025. In this episode: Sanofi’s Blueprint buy; AstraZeneca’s breast cancer resistance results at ASCO; BMS and BioNTech’s big bispecific deal; Kymera’s Dupixent in a pill; and Degron’s CEO on pipeline and strategy. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-T5ID4HF465BXFGAH7C6OOSEGTA/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Drug Fix: Prasad Staying Out Of Application Reviews, US FDA Proposed Budget Cuts

Fri, 06 Jun 2025 16:55:19 -0000

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss why seemingly routine comments from Vinay Prasad, director of the US Food and Drug Administration’s Center for Biologics Evaluation and Research, that he would stay away from daily review decisions were notable (:26), as well as the impact of proposed FDA budget cuts by the White House and the House of Representatives (17:16). More On These Topics From The Pink Sheet Prasad Says Involvement In US FDA Product Approvals Will Mirror Prior CBER Directors: https://insights.citeline.com/pink-sheet/rare-diseases/prasad-says-involvement-in-us-fda-product-approvals-will-mirror-prior-cber-directors-KF4LJWX5U5DLBMSM6D4YFL7ZOA/ To Compete With China, US FDA Must Deregulate Early Gene Therapy Studies, CAR-T Inventor Says: https://insights.citeline.com/pink-sheet/advanced-technologies/cell-and-gene-therapies/to-compete-with-china-us-fda-must-deregulate-early-gene-therapy-studies-car-t-inventor-says-VDVXZGZIJZFHHNGGQXYILBI7RM/ FDA’s FY 2026 Budget Request Lacks New Policy Proposals: https://insights.citeline.com/pink-sheet/legislation/fdas-fy-2026-budget-request-lacks-new-policy-proposals-WV3LE2AYBRAC7LIYJEU4WZDNGU/ User Fee-Funded Staff Would Drop In FY 2026 US FDA Budget: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/user-fee-funded-staff-would-drop-in-fy-2026-us-fda-budget-TQZMEB57V5GELNPMYGTY5BEGOY/ House Gives US FDA More Non-User Fee Funds Than Requested: https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/house-gives-us-fda-more-non-user-fee-funds-than-requested-PCQZCBHOB5ARPICMJJQ6VYIJ5M/

A Deep Dive into Sjögren's Disease

Fri, 06 Jun 2025 05:18:56 -0000

Summer Colling speaks with Emma Wille about the symptoms, diagnosis, and treatment landscape of Sjögren’s disease, highlighting the latest research and developments.

Digital Health Roundup: Synchron Syncs With Apple, Ketryx’s AI Agents, AdvaMed’s AI RoadMap

Wed, 04 Jun 2025 21:26:52 -0000

In this week's Digital Health Roundup, MedTech Insight's Shubham Singh explores how Ketryx's launch of validated AI agents could reshape compliance automation in medtech. Marion Webb highlights news from BCI makers Synchron, Axoft and Subsense. Elizabeth Orr discusses AI advances at the FDA.

Raj Panjabi on Flagship's Preemptive Health and Medicine Initiative

Tue, 03 Jun 2025 19:17:35 -0000

Flagship Pioneering senior partner Raj Panjabi discusses shifting healthcare from reactive treatment to AI-powered prediction and prevention of disease before symptoms emerge. Note: Raj Panjabi was mistakenly introduced as CEO-partner in the interview. His correct title is senior partner.

SGLT2 Inhibitors Cardiovascular and Safety Outcomes in Chronic Diseases

Tue, 03 Jun 2025 15:13:41 -0000

SGLT2 Inhibitors Cardiovascular and Safety Outcomes in Chronic Diseases by Citeline

Plant-Based Diet Improves Outcomes in Metastatic Breast Cancer

Tue, 03 Jun 2025 15:04:01 -0000

Plant-Based Diet Improves Outcomes in Metastatic Breast Cancer by Citeline

The Generics Bulletin Podcast: The Global Generics & Biosimilars Awards 2025

Tue, 03 Jun 2025 13:40:24 -0000

Generics Bulletin editors Dave Wallace and Dean Rudge discuss the Global Generics & Biosimilars Awards 2025, providing all the key details of the event coming up in Frankfurt this October, along with tips on how to make the most of your entries and opportunities to get more involved with the event.

Podcast: Navigating the Future of Hepatology Clinical Trials

Mon, 02 Jun 2025 10:50:39 -0000

Join Andrew Warmington, Manufacturing Editor at Citeline, in conversation with Tom Hickey, Director of Therapeutic Strategy at Novotech, a global full-service clinical CRO dedicated to accelerating the development of advanced and novel therapeutics. In this episode, recorded live at the European Association for the Study of the Liver Congress (EASL) in Amsterdam, Tom shares invaluable insights into the evolving landscape of hepatology clinical trials and the unique challenges and opportunities shaping the field today. Listen now to stay ahead in the dynamic world of clinical trials.

Innovation & Integrity: The Dual Path to Success for Device Makers

Mon, 02 Jun 2025 10:32:13 -0000

An expert from ISACA shares her insights into medtech’s Voluntary Improvement Program (VIP), a collaboration among participants, ISACA, MDIC, and US FDA formed to enhance patient safety and product quality in medical device manufacturing. Listen to learn more about attaining measurable improvements with the VIP.

Driving Innovation And Growth In France’s Self-Care Market, With Neres Luc Besançon

Mon, 02 Jun 2025 04:29:27 -0000

Largely driven by community pharmacy footfall, France’s self-care market is dynamic and characterized by high levels of innovation, according to French self-care industry association, NèreS. As NèreS’ executive director Luc Besançon explains in this episode of HBW Insight’s Over the Counter podcast, much of this is down to the tireless work of the association. Renaming self-care products as first-line or “premier recours” (first-line) products, identifying medicines that are available OTC in other countries that could be switched in France and quantifying the impact that the revised Urban Wastewater Treatment Directive would have on access to medicines are all strands of NèreS’ pathbreaking recent work. Timestamps 2:20 – Introductions 3:00 – France’s self-care market 7:50 – Innovation in supplements and devices 11:00 – “Premiere recourse” products 13:00 – Driving reclassification 18:00 – Harmonising Rx-to-OTC switch across Europe 20:00 – Switch environment in France 26:00 – Impact of Urban Wastewater Treatment Directive in France 33:00 – Who should pay? 37:00 – NèreS priorities for 2025

Scrip's Five Must-Know Things - 2 June 2025

Mon, 02 Jun 2025 02:05:05 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 30 May 2025. In this episode: a preview of major ASCO readouts; Roivant stays patient in deals; Lilly diversifies pain pipeline with SiteOne acquisition; Nucala gets US COPD nod; and women in Indian pharma. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-L4LQVHCXLRFEDBOU657R5SEMJY/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Drug Fix: US FDA’s Private Pharma CEO Tour, HHS Changes COVID-19 Vaccine Recommendation

Fri, 30 May 2025 16:53:56 -0000

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the potential comments that US Food and Drug Administration Commissioner Martin Makary and other senior agency leaders could receive during their pharma CEO listening tour (:30), as well as the impact of Health and Human Services Secretary Robert F. Kennedy Jr.’s decision to change US Centers for Disease Control and Prevention policy and no longer recommend healthy children and pregnant women receive COVID-19 vaccines (15:47). More On These Topics From The Pink Sheet US FDA Makary’s Pharma CEO Tour Goes Against Transparency Rhetoric: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-makarys-pharma-ceo-tour-goes-against-transparency-rhetoric-3E5RP5IATVD73DRPQHZPSTHKRA/ HHS Rescinds COVID-19 Vaccine Advice, Usurping US CDC Role: https://insights.citeline.com/pink-sheet/vaccines/hhs-rescinds-covid-19-vaccine-advice-usurping-us-cdc-role-YNFI7TU5CFGERIGFG7ISOJ4X5Q/

FDA in Transition: How Regulatory Shifts Are Redefining Drug Development

Tue, 27 May 2025 09:39:44 -0000

The uncertainty surrounding changes at the FDA and other market dynamics is reshaping the global drug development landscape. In this webinar, CRO regulatory leaders will summarize the collective experience of the biotech companies we’ve spoken to recently. We will explore: • The impact of the FDA leadership changes, staffing cuts, and return to office mandates in reshaping regulatory priorities. • Trends we’re observing from biotech sponsors on the decision of whether or not to keep trials in the US. • The broader implications for industry investment, pipeline prioritization strategies, and international responses. This episode is part 1 of 4 in the series “Navigating Regulatory Changes & Market Dynamics: CRO Perspectives on the Future of Clinical Trials”, featuring insights from Novotech on evolving trends impacting global clinical development. Stay tuned for the next episode, where we’ll continue exploring the key forces shaping the future of clinical trials.

Scrip's Five Must-Know Things - 26 May 2025

Mon, 26 May 2025 08:21:15 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 23 May 2025. In this episode: Novo Nordisk’s CEO forced out; quantifying biopharma’s contribution to the US economy; a history of MASH deals; lift for AstraZeneca’s asthma ambitions; and major Japanese firms see US revenue growth. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-XJZXECGBDRDJLCM6FBOJSZNPK4/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Drug Fix: US FDA’s Big Vaccine Policy Week

Fri, 23 May 2025 17:51:24 -0000

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the limited label that Novavax received for its new COVID-19 vaccine Nuvaxovid, the impact of the new COVID-19 vaccine development policy announced by the US Food and Drug Administration and additional upcoming indicators of the evolving policy. More On These Topics From The Pink Sheet Novavax’s COVID-19 Vaccine Label Narrowed After Political Officials Intervened: https://insights.citeline.com/pink-sheet/vaccines/novavaxs-covid-19-vaccine-label-narrowed-after-political-officials-intervened-56OPC7DJ6NCXFLQYGE27SVTEH4/ Legal, Process Problems May Plague New US FDA COVID-19 Vaccine Policy: https://insights.citeline.com/pink-sheet/vaccines/legal-process-problems-may-plague-new-us-fda-covid-19-vaccine-policy-HAUDHEREXZCA5DAZ47HZ6L544U/ Observational, Retrospective Trials Could Retest Vaccines, HHS’ Kennedy Says: https://insights.citeline.com/pink-sheet/vaccines/observational-retrospective-trials-could-retest-vaccines-hhs-kennedy-says-BOFKDMMHGVDNXKXMFEILOXAH4E/ US FDA COVID-19 Booster Strategy May Not Be As Controversial As It Seems: https://insights.citeline.com/pink-sheet/vaccines/us-fda-covid-19-booster-strategy-may-not-be-as-controversial-as-it-seems-ZEAHMHE5LJB6HLBT2WRZW4L3AY/ US FDA Punts On New COVID-19 Framework’s Impact On Fall Shots: https://insights.citeline.com/pink-sheet/product-reviews/us-advisory-committees/us-fda-punts-on-new-covid-19-frameworks-impact-on-fall-shots-QSB6OPEB4ZCEFLS36JG3Y7XSPE/

“Powerful Yet Unexplored”: Commit Biologics Tackles The Complement System

Tue, 20 May 2025 16:01:32 -0000

Mikkel Wandahl Pederson, CEO and chief scientific officer at Commit Biologics, discussed the company’s mission to harness the powerful complement system for the treatment of serious diseases.

제약바이오딜 투자수익률 하락…시장 불안정으로 상황 악화될 수도 (Korean-language podcast)

Tue, 20 May 2025 07:41:03 -0000

바이오기업 가치상승으로 일부 딜 (deal)의 경우 빅파마의 투자수익률 (ROI)이 거의 없는 상황이지만, 특정 전략으로 성공 가능성을 높일 수 있다는 Scrip 기사를 요약한 내용입니다. https://insights.citeline.com/scrip/business/deals/biopharma-deals-roi-has-fallen-and-market-instability-could-make-it-worse-MV7Z55MUW5EB7CWVF6JYKHZWUA/ Playlist: soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini

Taking Real-World Evidence Seriously, With IQVIA Consumer Health’s Volker Spitzer

Tue, 20 May 2025 05:03:39 -0000

While few doubt the opportunity represented by real-world evidence, some concerns remain about its validity compared to traditional forms of clinical evidence, particularly among regulators. To address these concerns, IQVIA Consumer Health’s vice president of global research and development and real-world evidence services, Volker Spitzer, suggests that incorporating some elements of traditional trials, such as randomization, is a good way to persuade regulators that RWE can be used for consumer health innovation, for example in generating new claims or supporting Rx-to-OTC switch. Looking forward, Spitzer is excited about the ways in which digital health tools and artificial intelligence can be used to expand the scope of RWE as well as drive personalization for consumers. Timestamps: 3:00 - Addressing concerns about RWE’s scientific rigour and validity 12:00 – Regulators’ views of RWE, particularly for consumer health 16:00 – Use of RWE for Rx-to-OTC switch 22:00 – The future of RWE Guest Bio: Volker Spitzer has more than 30 years of R&D experience spanning the consumer health sector, ingredients industry, and academia. Beginning his career as a professor in pharmaceutical sciences, he ascended to global positions encompassing R&D, innovation, licensing/M&A, and medical marketing at firms like Roche, DSM Nutritional Products, and Bayer. Since October 2017, Spitzer has been affiliated with IQVIA Consumer Health, serving as the vice president for global R&D and RWE Services. His purview primarily includes clinical research, RWE, virtual trials, and the burgeoning field of digital health. He has penned over 80 scientific publications, whitepapers and textbooks centered on science and innovation.

Scrip's Five Must-Know Things - 19 May 2025

Mon, 19 May 2025 02:52:00 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 16 May 2025. In this episode: Trump’s executive order more rhetoric than action; industry grapples with Trump pricing plan; Hengrui set for this year’s biggest IPO; Sanofi’s exec’s advice to biotechs; and biotech deal return on investment falls. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-D4WWGRDN7VB3BB2KULQYTQFKJM/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

China Biopharma Podcast - 14 May 2025 (Chinese language)

Wed, 14 May 2025 05:41:53 -0000

在本期中国生物技术播客中，Dexter Yan回顾了他在4月的美国癌症研究协会年会（AACR）举办前和再鼎医药总裁及全球肿瘤研发负责人Rafael Amado的采访。Amado在采访中详细阐述再鼎在AACR展示的两个临床前项目，分别是PD-1/IL-12 双抗和靶向LRRC15的抗体偶联药物（ADC）。Dexter还采访到Arbele的创始人和CEO John Luk，请他介绍Arbele在钙粘蛋白17（CDH17）靶点研发上的最新进展和心得体会。最后Dexter回顾了4月维升药业和映恩生物在香港交易所首次上市的情况。此外，Xu Hu分享了她最近撰写的有关中国企业研发肠促胰岛素类体重管理药物的综述。除此之外，Xu点评了中国药监局最近公布的有关药品试验数据保护的征求意见稿。

Scrip's Five Must-Know Things - 12 May 2025

Mon, 12 May 2025 04:06:03 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 9 May 2025. In this episode: industry makes its case to Trump; Sarepta slammed by double blow; Chinese firms build obesity pipeline; Swiss biopharma staying strong; and Merck & Co looks to immunology and ophthalmology. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-HVFSXCWENFCU7FLRVPHK3P4WFU/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Drug Fix: A New Director For US FDA’s Biologics Center, Guidance Production Slowdowns

Fri, 09 May 2025 16:36:27 -0000

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider early excitement and concern about Vinay Prasad’s potential impact on product development as director of the US Food and Drug Administration’s Center for Biologics Evaluation and Research (:20). They also consider the consequences of the FDA missing product-specific guidance publication deadlines (14:59) and its potential impact on the upcoming user fee reauthorization negotiations (20:00). More On These Topics From The Pink Sheet Tougher Approval Standards May Follow Vinay Prasad’s Appointment To Lead US FDA’s CBER: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/tougher-approval-standards-may-follow-vinay-prasads-appointment-to-lead-us-fdas-cber-WEULXI5EJRE43BWU752PGDGE44/ US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/generics/us-fda-guidance-roadblock-writing-continues-but-publication-has-slowed-or-stopped-TZF4DMPEMVHT3JJPRUX7LJJIHU/

Scrip's Five Must-Know Things - 7 May 2025

Wed, 07 May 2025 02:34:53 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 2 May 2025. In this episode: AstraZeneca CEO cautions Europe; Pfizer CEO optimistic on US tariffs, pricing; Merck & Co reassures on pipeline; Merck KGaA buys SpringWorks; and Akeso explains ivonescimab overall survival data. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-LV7ZA2GKQVHEZDZYYNZFKYQZ74/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Everything You Wanted To Know About Real World Evidence, With IQVIA’s Volker Spitzer

Tue, 06 May 2025 03:03:12 -0000

The potential for real world evidence (RWE) is huge, according to enthusiasts, but to the uninitiated it can seem like a complicated and forbidding subject. In this Over the Counter double episode, IQVIA Consumer Health’s vice president of global research and development and real-world evidence services, Volker Spitzer, makes understanding real world evidence easy. We start with the basics, with what it is and what companies need to know about it, and what the key difference is with randomised control trials. Many companies are already using real world evidence, Volker notes, and he extracts some key lessons for companies interested in trying it out based on his extensive experience working with industry on such projects. Timestamps 2:00 – Introductions 4:00 – What is real world evidence? 5:00 – Can RWE and clinical trials complement each other? 10:00 – Why RWE is particularly attractive today 14:00 – Don’t reinvent the wheel 18:00 – Why is this important for consumer health companies? 25:00 – Why RWE is often a good value option, especially for SMEs 33:00 – Applications of RWE in consumer health Guest Bio Volker Spitzer has more than 30 years of R&D experience spanning the consumer health sector, ingredients industry, and academia. Beginning his career as a professor in pharmaceutical sciences, he ascended to global positions encompassing R&D, innovation, licensing/M&A, and medical marketing at firms like Roche, DSM Nutritional Products, and Bayer. Since October 2017, Volker has been affiliated with IQVIA Consumer Health, serving as the vice president for global R&D and RWE Services. His purview primarily includes clinical research, RWE, virtual trials, and the burgeoning field of digital health. He has penned over 80 scientific publications, whitepapers and textbooks centered on science and innovation.

OPPI’s Matai On India’s IPR Regime: Progress, Pain Points, Possibilities

Mon, 05 May 2025 07:11:39 -0000

Anil Matai, director general, Organization of Pharmaceutical Producers of India, discusses the evolving intellectual property landscape in India post the 2024 amendments and long-standing sticking points including Section 3(d) of India’s patent regulations and regulatory data protection. Big pharma’s experience when it comes to the Bolar provision and the impact of geopolitical shifts on innovation were some of the other topics he touched on.

Drug Fix: Vaccine Review Political Interference, Missed Deadlines A Harbinger Of US FDA Problems?

Fri, 02 May 2025 17:19:27 -0000

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor in Chief Nielsen Hobbs consider the impact of FDA Commissioner Martin Makary directing one of his assistants to take over the review of Novavax’s COVID-19 vaccine (:40), as well as how states or courts could respond (19:19). They also discuss several announcements of missed user fee deadlines and whether FDA layoffs could have contributed (28:33). More On These Topics From The Pink Sheet Updated: Makary Backs New Novavax COVID-19 Trial, Political Officials Take Over Product Review: https://insights.citeline.com/pink-sheet/vaccines/political-official-pushing-novavax-to-conduct-covid-19-vaccine-postmarket-rct-BZTIWKSTK5G77BUQGGD3G2IOFY/ How States And Courts Could Insulate America From An Anti-Vaccine Executive Branch: https://insights.citeline.com/pink-sheet/vaccines/how-states-and-courts-could-insulate-america-from-an-anti-vaccine-executive-branch-DARDVWDMLVFCHM6DE75AJQHSBQ/ US FDA Commissioner’s Office Plans Involvement In Many Approvals In Potential Major Change: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-commissioners-office-plans-involvement-in-many-approvals-in-potential-major-change-JFPWOQ2VF5D2JAFKXKGK54REZU/ US FDA Miss On Stealth’s Elamipretide Boosts Signal Of Broader Delays Due To Staff Cuts: https://insights.citeline.com/pink-sheet/product-reviews/us-fda-miss-on-stealths-elamipretide-boosts-signal-of-broader-delays-due-to-staff-cuts-5ITZREGXX5H75ID6IL4Q2MHKBE/

Scrip M&A Podcast: Will the FDA Staff Cuts Affect Biopharma M&A Activity?

Thu, 01 May 2025 18:44:12 -0000

Scrip senior writer Joseph Haas discusses the potential impact of the recent FDA staff cuts with attorneys Andrew Goodman of Paul Hastings LLP and Alan Minsk of Arnall Golden Gregory, as well as Naya Therapeutics CEO Daniel Teper

Conference Catch-Up: BIO-Europe 2025

Thu, 01 May 2025 03:18:37 -0000

In this episode, we recap the key takeaways from BIO-Europe 2025, held in Milan, Italy, in March 2025, with Trajko Spasenovski, Vice President of Strategic Account Management at Evaluate, and Carolyn Hall, Senior Director of Content and Thought Leadership Marketing at Evaluate. After the conference, Citeline’s Managing Editor, Meredith Landry, spoke with them about their experience there and what they learned about trends in early-stage deal-making, emerging areas like cardiovascular and rare disease therapies, and the expanding role of AI in R&D. Trajko and Carolyn also shared how conferences like BIO-Europe help Norstella and its clients forge meaningful partnerships, uncover market needs, and accelerate the path to life-saving therapies through data-driven insights and strategic collaboration.

Highlights from AAN 2025

Wed, 30 Apr 2025 02:54:56 -0000

Emma Wille and Summer Colling discuss the 2025 American Academy of Neurology (AAN) conference with CNS and I&I analysts Wen-Yu Huang, Joseph Jacob and Istafa Armughan.

Aragen CEO On Funding Cuts At NIH, Biotechs And Likely US Pharma Tariffs

Tue, 29 Apr 2025 05:28:01 -0000

Aragen Life Sciences’s CEO Manni Kantipudi - also former CIO of Intel Asia - speaks with Citeline’s senior editor Vibha Ravi about the changing global supply chain dynamics as the industry watches a ticking time bomb of US tariffs on pharmaceuticals. Impacts on Indian CRDMOs of the US-China trade war, budget cuts at US NIH and lower funding for biotechs are discussed.

Scrip's Five Must-Know Things - 28 April 2025

Mon, 28 Apr 2025 02:56:03 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 25 April 2025. In this episode: 2024’s top-selling drugs; two CEOs call for higher Europe drug prices; diabetes trial win for Lilly’s orforglipron; BMS trial failure in schizophrenia; and an analysis of alliance deal-making last year. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-6L5MDUXZ5BGHJHLZFILGLH6ZT4/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Drug Fix: More US FDA Departures, Makary On Combined AE Database, ‘Conditional’ Approval

Fri, 25 Apr 2025 17:42:15 -0000

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Senior Editor Sue Sutter discuss the impact of the departures of several senior leaders in the US Food and Drug Administration’s facility inspection group, Office of Generic Drugs and Office of Prescription Drug Promotion (:26). They also consider Commissioner Martin Makary’s intent to combine the agency’s many adverse event databases (14:52), his idea for a new approval pathway based on a “plausible mechanism” (26:25) and the seemingly increasing influence of politics at the agency despite his declarations that the FDA is apolitical (36:16). More On These Topics From The Pink Sheet US FDA Retirements Continue Unabated With Drug Inspectorate Leaders, Former Chief Counsel: https://insights.citeline.com/pink-sheet/compliance/manufacturing/us-fda-retirements-continue-unabated-with-drug-inspectorate-leaders-former-chief-counsel-JRKHCHZHMBC4RLRJRBDTSIP7E4/ FDA Leadership Shuffle Continues: Lowell Zeta Returns As OPDP, OGD Leaders Depart: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/fda-leadership-shuffle-continues-lowell-zeta-returns-as-opdp-ogd-leaders-depart-FONMRWR37VGAFL2JJ5S27QIU2E/ US FDA’s Makary Floats Vague ‘Plausible Mechanism’ Approval Pathway For Rare Diseases: https://insights.citeline.com/pink-sheet/pathways-and-standards/approval-standards/us-fdas-makary-floats-vague-plausible-mechanism-approval-pathway-for-rare-diseases-RJJJCPDUDFHINMPDE5VK4OFDVQ/ US FDA Commissioner Makary Wants To Combine Adverse Event Reporting Systems: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-commissioner-makary-wants-to-combine-adverse-event-reporting-systems-UJ4QUEM72ZC25J7JHAC3LAKKKA/ Political Influence And The US FDA: A New Era?: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/political-influence-and-the-us-fda-a-new-era-SL6ZBNKHNVFEXCLQLCYTDJIETQ/

Precision Medicine in Liver Treatment: The Ochre Bio Approach

Wed, 23 Apr 2025 15:31:06 -0000

Ochre Bio co-founder and CSO Quin Wills spoke with In Vivo about the UK-based company's novel approach to finding and validating RNA therapies for chronic liver diseases.

Scrip's Five Must-Know Things - 21 April 2025

Mon, 21 Apr 2025 02:32:51 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 18 April 2025. In this episode: Trump’s drug pricing executive order; J&J says taxes, not tariffs, influence US manufacturing; Pfizer discontinuation sparks M&A speculation; US tariffs and manufacturing concentration; and tariffs’ pressures on pharma’s complex supply chain. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-ROAXNELATJBXDMNSHISARWARPY/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Brands, Brexit And New Self-Care Business Models, With PAGB’s Michelle Riddalls

Fri, 18 Apr 2025 04:36:23 -0000

Summary: At the heart of any successful self-care business is a portfolio of recognizable and trusted consumer health brands. These brands could play a key role in unlocking the potential of digital self-care in the UK, suggests Michelle Riddalls, in this second part of her Over the Counter interview. As PAGB CEO, Michelle has seen first had how the UK consumer health industry has been transformed, for example also by Brexit. Has the UK’s exit from the EU realised the promises of innovation unleashed from bureaucracy? Not so far, Michelle reflects, but it might be too soon to tell. What she can predict is that with its new five-year strategy, PAGB will remain dedicated to supporting UK firms in navigating a continuously evolving industry landscape. Timestamps 2:00 – Digital consumer health in the UK 7:00 – The power of brands 12:00 – Brexit, promise realised? 20:00 – What’s next for the UK OTC industry? Guest Bio Michelle Riddalls OBE is Chief Executive Officer of PAGB, the consumer healthcare association, which represents the manufacturers of branded over-the-counter (OTC) medicines, self-care medical devices and food supplements in the UK. Prior to joining PAGB, Michelle was Director of Regulatory Affairs for the Northern European Cluster at Pfizer Consumer Healthcare, where she was integral in the highly successful POM to GSL reclassification of Nexium Control and the Viagra Connect POM to P switch. Michelle has been recognised across a number of industry awards, including the Women in Trade Powerlist in 2024, and was awarded an OBE for outstanding services to consumer health in the King’s 2025 New Year Honours.

Scrip's Five Must-Know Things - 14 April 2025

Mon, 14 Apr 2025 02:43:58 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 11 April 2025. In this episode: Trump’s tariff rollercoaster; regulatory, economic uncertainties hang over Q1 earnings; IPOs rise in Q1 but may slow; Chinese deal-making matures; and AstraZeneca talks about Chinese innovation. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-X3YNW3ZLVZABLNFILQHNH6FPAE/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

미국 관세 롤러코스터에 제약업계는 여전히 불안 (Korean-language podcast)

Fri, 11 Apr 2025 07:51:18 -0000

미국이 수입 의약품에 관세를 부과할 가능성은 여전하지만, 트럼프의 최근 발표로 인해 이를 시행하는 데 시간이 더 걸릴 수 있다는 Pink Sheet (Citeline Regulatory) 기사를 요약한 내용입니다. https://insights.citeline.com/pink-sheet/compliance/distribution-supply-chain/pharma-still-nervous-while-riding-trumps-tariff-rollercoaster-DFQMWLGXSZBS3K34UY2OE6TUVA/ Playlist: soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini

Scrip's Five Must-Know Things - 7 April 2025

Mon, 07 Apr 2025 00:00:00 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 4 April 2025. In this episode: pharma dodges tariffs for now; Marks’s departure from FDA rattles industry; Phase 2b win for AstraZeneca’s oral PCSK9; Hengrui renews global Phase 3 push; and Novo’s new cardio results for semaglutide. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-MPJF4YP4NFAQ5JEDFBEIW62LBE/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Evolving The UK Consumer Health Industry, With PAGB’s Michelle Riddalls

Mon, 07 Apr 2025 00:00:00 -0000

Exerting maximum influence on stakeholders, helping companies navigate regulatory complexity and promoting industry best practice are three big jobs that the UK consumer healthcare industry association, PAGB, has set itself for the next five years. In the last five years, PAGB has made significant headway with UK government, reports PAGB CEO Michelle Riddalls, establishing the economic and social value of self-care and ensuring that self-care is part of the UK’s national healthcare strategy. Rx-to-OTC switch has been a major area of success, Michelle notes in this episode of the Over the Counter podcast. The Department of Health and Social Care recently published a list of switches it would like to see applications for, and PAGB is now facilitating members to take advantage of this opportunity. But there’s always more work to be done. Switch involves significant risk, which PAGB is trying to reduce through further work with policy makers, and with a new government, the association must ensure that self-care remains high up on the agenda for politicians. Given the breadth of PAGB’s work discussed by Michelle, we have split this episode into two, so watch out for the second part in two weeks’ time on your favourite podcast provider and on Citeline’s HBW Insight. Timestamps 2:10 – Introductions 2:40 – PAGB’s new five-year strategy 5:40 – Evolution not revolution 8:00 – Self-care and UK government policy 10:30 – Quantifying the value of self-care 12:30 – Lobbying around AMR and OTCs 16:00 – Rx-to-OTC switch in the UK 24:00 – The power of brands Guest Bio Michelle Riddalls OBE is Chief Executive Officer of PAGB, the consumer healthcare association, which represents the manufacturers of branded over-the-counter (OTC) medicines, self-care medical devices and food supplements in the UK. Prior to joining PAGB, Michelle was Director of Regulatory Affairs for the Northern European Cluster at Pfizer Consumer Healthcare, where she was integral in the highly successful POM to GSL reclassification of Nexium Control and the Viagra Connect POM to P switch. Michelle has been recognised across a number of industry awards, including the Women in Trade Powerlist in 2024, and was awarded an OBE for outstanding services to consumer health in the King’s 2025 New Year Honours.

Drug Fix: Understanding The US FDA Reduction-In-Force And Its Long-Term Impact

Fri, 04 Apr 2025 00:00:00 -0000

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter, and Editor-in-Chief Nielsen Hobbs discuss the impact of the 1 April reduction-in-force on the US Food and Drug Administration, which targeted about 3,500 employees (:30). They also consider how and whether service levels will change (13:28), and new Commissioner Martin Makary’s first address to the drastically smaller staff the day after the RIF was announced (29:22). More On These Topics From The Pink Sheet Updated: US Likely To Lose Its First Approver Advantage After FDA Layoffs: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/fda-layoffs-us-likely-to-lose-its-first-approver-advantage-5C37YQ73DNBEFF7SHRYV4MJUIA/ Are Bigger Ad Policy Changes Coming After US FDA’s Drug Promotion Office Hit Hard By Layoffs?: https://insights.citeline.com/pink-sheet/compliance/marketing-and-advertising/are-bigger-ad-policy-changes-coming-after-us-fdas-drug-promotion-office-hit-hard-by-layoffs-FQLHKJ4GWRCXLEIZCEMX37SUYU/ Dramatic HHS Layoffs A Response To ‘Existential Crisis,’ Kennedy Advisor Argues: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/dramatic-hhs-layoffs-a-response-to-existential-crisis-kennedy-advisor-argues-XZKO5PJF6RHGHLABD2TZY7K2N4/ CDRH Staff Cuts Focus On Administrative Workers, Spare Reviewers: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/cdrh-staff-cuts-focus-on-administrative-workers-spare-reviewers-DL3L63CAGFGYTDAICFSXG5JP34/ Makary Pledges To Uphold Gold Standard Science, But First Address Confuses Some US FDA Staff: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/makary-pledges-to-uphold-gold-standard-science-but-first-address-confuses-some-us-fda-staff-WE7A5TQARBHX3MS6LGDIQT5CRY/ US FDA Restructuring May Be Next After Drugs Center Loses More Than 1,000 People: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-restructuring-may-be-next-after-drugs-center-loses-more-than-1000-people-HOZ7IYGEC5BYBMNNUPAT2TBNI4/

CEO Nicolas Poirier on OSE Immunotherapeutics Latest IL-7 Data

Thu, 03 Apr 2025 00:00:00 -0000

OSE Immunotherapeutics' CEO Nicolas Poirier talks about the company's IL-7 receptor agonist, lusvertikimab, recent data presented at The European Crohn's and Colitis Organization congress, commercialization and development strategy and the future of IBD therapy.

Digital Health Roundup: Intuitive CEO Exec Chat, Patient Monitoring, Exer Labs Woes, Roche New NGS Prototype

Wed, 02 Apr 2025 00:00:00 -0000

In this week’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights her interview with Gary Guthart, CEO of Intuitive Surgical about the new da Vinci 5 surgical robot and the future of robotics in surgery. Brian Bossetta talks about the recently FDA-cleared patient monitoring system that sends vital signs directly to clinician staff. Elizabeth Orr discusses an FDA warning letter to Exer Labs and Shubham Singh discusses Roche’s new NGS Prototype, expected to challenge Illumina.

Scrip's Five Must-Know Things - 31 March 2025

Mon, 31 Mar 2025 00:00:00 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 28 March 2025. In this episode: Merck & Co. licenses Hengrui’s lipid lowerer; Novo gets United’s triple G obesity drug; J&J plans major US manufacturing investments; approval for GSK’s novel antibiotic; and a call for more aggressive Korean M&A activity. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-7API33OTGJELXGC7RGOH2KK2G4/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Innovative Oncology, A Conversation with iOnctura

Fri, 28 Mar 2025 00:00:00 -0000

In Vivo spoke with UK biotech CEO Catherine Pickering about developing innovative therapies for challenging cancer types, the progress of iOntura's lead asset, roginolisib, for uveal melanoma, and the strategies that have helped secure over €100m in private financing.

Drug Fix: Understanding The Impact Of The Latest HHS Layoffs On The US FDA

Fri, 28 Mar 2025 00:00:00 -0000

Introduction: Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, and Senior Editor Sue Sutter discuss the impact of the 3,500 layoffs on the US Food and Drug Administration, including the areas where the agency could lose some autonomy (:28). They also consider worries that the agency’s preparations for user fee reauthorization negotiations may be slowing because of the upcoming staffing cuts (24:09). More On These Topics From The Pink Sheet Power Play: US FDA Likely Losing More Than Just Staff With Restructured Health Department: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/power-play-us-fda-likely-losing-more-than-just-staff-with-restructured-health-department-BT5YZ4U7WNANBEZN7OBF42LCEE/ US FDA Staffing Uncertainty Could Impact Upcoming User Fee Negotiations: https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/us-fda-staffing-uncertainty-could-impact-upcoming-user-fee-negotiations-EAUTZOANHVB3PK6NKCLJCYTOLA/ Can New US FDA Commissioner Makary Calm Agency During Turbulent Times?: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/can-new-us-fda-commissioner-makary-calm-agency-during-turbulent-times-STBAXTWCIFEGJPDYZ6LZKMRPE4/

Podcast: Heranova CMO Advocates For Endometriosis Awareness: “Pain Is Not Normal”

Wed, 26 Mar 2025 00:00:00 -0000

Farideh Bischoff, chief medical officer of Heranova Lifesciences, discusses the urgent need for better diagnostic options and the latest innovations transforming care for endometriosis patients.

What To Expect From The 61st AESGP Annual Meeting, With AESGP’s Jurate Švarcaite

Mon, 24 Mar 2025 00:00:00 -0000

Europe’s self-care industry leaders, policymakers and stakeholders are heading to Warsaw, Poland between the 4th and 6th June this year for the Association of the European Self-Care Industry’s 61st Annual Meeting. With Poland heading up the EU Council and the country being one of the largest and most self-care friendly markets in Europe, the location made sense, explains AESGP director general Jurate Švarcaite, in this episode of Over the Counter. As always, there’s a jam-packed line up for the event, which every year sets the agenda for industry in the months to come. Highlights for Jurate include sessions on the role of prevention in self-care and the competitiveness of European industry on the world stage. I’m personally also looking forward to discussions about how industry will square the circle of sustainability, with medicines posing unique challenges for both regulators and manufacturers. Sign up for AESGP’s 61st Annual Meeting: https://aesgp.eu/events/61st-aesgp-annual-meeting

Scrip's Five Must-Know Things - 24 March 2025

Mon, 24 Mar 2025 00:00:00 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 21 March 2025. In this episode: Pfizer tops pharma leaderboard; AstraZeneca buys into in vivo cell therapy; Almirall looks to dominate derma spectrum; Incyte’s HS contender looks approvable; and MSD’s Williams says pharma should shorten tech adoption cycles. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-EGD3MLOIVJDKRCE32KV376CJ5Q/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Drug Fix: US FDA Productivity Complaints Emerge, Internal Return To Office Headaches

Fri, 21 Mar 2025 00:00:00 -0000

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Editor-in-Chief Nielsen Hobbs discuss industry stakeholders’ complaints about US Food and Drug Administration productivity declines in the weeks since President Trump took office and began making changes and the potential recourse for industry (:24). They also review the expected and emerging problems with the agency requiring nearly all of its Washington, D.C.-area staff to return to in-office work at its White Oak headquarters and consider its impact on workflow going forward (15:35). More On These Topics From The Pink Sheet US FDA’s Speed Of Work Under Trump Quietly Raising Industry Concerns: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-speed-of-work-under-trump-quietly-raising-industry-concerns-ZWM522FIDJAO7DVAJYZRLLDFAI/ US FDA Survives First Day Of Return To In-Office Work, But True Test Upcoming: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-survives-first-day-of-return-to-in-office-work-but-true-test-upcoming-AZOWC5ITNNGGVG3TIGGWR5VMBA/ Cramped Quarters, Limited Parking And Water Concerns Await US FDA’s Return To Office: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/cramped-quarters-limited-parking-and-water-concerns-await-us-fdas-return-to-office-YWHJRM6RTZF4NJP2MZX4Y6LLQA/

Scrip's Five Must-Know Things - 17 March 2025

Mon, 17 Mar 2025 00:00:00 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 14 March 2025. In this episode: Roche’s big new obesity deal; J&J opts out of next-gen Darzalex; Arvinas and Pfizer’s protein degrader misses Phase III endpoint; Kelun wins first TROP2 ADC approval in lung cancer; and big name brands poised to lose US exclusivity. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-QOIAKBVZ2FDQ7NL2SFMWK66HP4/ This episode was produced using AI text-to-voice and voice emulation software. Let me know your views: ian.haydock@citeline.com. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Drug Fix: Buyouts, Departures and Other US FDA Chaos

Fri, 14 Mar 2025 00:00:00 -0000

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Editor-in-Chief Nielsen Hobbs discuss the US Food and Drug Administration’s early retirement and buyout programs to further cut its workforce (:25), leadership departures in the Center for Biologics Evaluation and Research (9:13), the quick arrival and resignation of a new FDA chief counsel (12:35), and Commissioner nominee Martin Makary closing in on confirmation, as well as the impact of the staffing changes on the agency he likely will be running (22:45). More On These Topics From The Pink Sheet US FDA Reviewers, Inspectors Not Eligible For HHS Buyouts: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-reviewers-inspectors-not-eligible-for-hhs-buyouts-PHAPCCR7NZBCRKRL6NPQANGGW4/ User Fee Deadline Concerns Emerge As US FDA Buyout Offer Sweetened With Paid Leave: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/user-fee-deadline-concerns-emerge-as-us-fda-buyout-offer-sweetened-with-paid-leave-WRCP4JYKTJHZPP3QTLGJQPTS54/ CBER Losing Cell, Gene Therapy Leadership As Workforce Culling Continues: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/cber-losing-cell-gene-therapy-leadership-as-workforce-culling-continues-CAWLALTKUVFADETC7HZEXMJQKA/ US FDA May Lose Some Autonomy Under Health Department’s General Counsel Reorg: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-may-lose-some-autonomy-under-health-departments-general-counsel-reorg-VUS3GIMCLBE2TC2BUL7UHMIEP4/ Makary US FDA Nomination Advances, Last Minute Hiccup May Offer Clues On Mifepristone: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/makary-us-fda-nomination-advances-last-minute-hiccup-may-offer-clues-on-mifepristone-XQXLBN7HRNGUPCNV3XEUHR3ASA/ Don’t Ask, Don’t Tell: Senate Democrats Ready To Embrace Makary Heading US FDA: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/dont-ask-dont-tell-senate-democrats-ready-to-embrace-makary-heading-us-fda-AOZR6OAM5RHF5ECCOYGQPV77HQ/

Vaccines, Viruses & Variants: The State of COVID-19 & Flu in 2025

Tue, 11 Mar 2025 00:00:00 -0000

Summer Colling and Emma Wille speak with Datamonitor Healthcare's infectious disease analysts Charlotte Holmes and Natasha Boliter to discuss the latest trends in COVID-19 and influenza, including their global impact, vaccine developments, and the challenges in prevention. The experts break down the science behind these viruses, the future of combination vaccines, and what’s next for respiratory disease prevention.

Scrip M&A Podcast: Looking at M&A activity as Q1 2025 nears a close.

Tue, 11 Mar 2025 00:00:00 -0000

Scrip senior writer Joseph Haas discusses the latest biopharmaceutical merger-and-acquisition activity and trends with attorneys Jessica Bisignano and Gabrielle Witt of Hogan Lovells.

The Generics Bulletin Podcast: Stelara Biosimilar Launches In The US

Tue, 11 Mar 2025 00:00:00 -0000

Generics Bulletin editors Dave Wallace and Dean Rudge discuss the latest updates on Stelara (ustekinumab) biosimilars in the US, including recent launches, pricing strategies, and parallels with the biosimilar Humira (adalimumab) experience.

Scrip's Five Must-Know Things - 10 March 2025

Mon, 10 Mar 2025 00:00:00 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 7 March 2025. In this episode: low-cost Wegovy an alternative for US self-payers; Bayer rolls up sleeves for turnaround; taking the pulse of NewCo creation; the outlook for Alzheimer’s; and India’s rare disease landscape. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-HRMLFN6ZKBHU5KRWSZLLCL3VYY/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things Release date: 3 March 2025

Women’s Health Innovation And Beyond, With Maxwellia’s Anna Maxwell

Mon, 10 Mar 2025 00:00:00 -0000

Summary: The UK’s Maxwellia has been on quite a journey, from “switch-in-a-box” start-up to a consumer healthcare company in its own right, launching some of the most innovative products on the way. Specialising so far in women’s health, with OTC brands ranging from the first-in-class daily contraceptive pill to much needed menstrual health solutions, Maxwellia CEO Anna Maxwell now has her eye on a recently published list of Rx-to-OTC switched the UK government would like to see applications for. To realise these switches, Maxwell calls for the government to make it easier for smaller companies like Maxwellia to access all important funding. Timeline 2:00 – Introductions 3:00 – Maxwellia’s growth journey 11:00 – Innovating in women’s health 20:00 – Room for growth in the women’s health category 21:00 – UK government’s Rx-to-OTC switch wishlist 25:00 – The advantages of being a small company 27:00 – Beyond women’s health 30:00 – The disadvantages of being a large company 31:20 – Maxwellia’s immediate future Guest Bio Anna Maxwell is a pioneering pharmacist and healthcare entrepreneur reshaping public health by making essential medicines more accessible. As founder and CEO of Maxwellia, she’s driving growth with strong retail partnerships, a robust innovation pipeline, and plans for international expansion. With a clear vision and relentless drive for innovation, Maxwell is leading a movement to give people more control over their health – “because the future of self-care is here, and Maxwellia is making it happen.”

Drug Fix: What We Learned From US FDA Commissioner Nominee Makary’s Confirmation Hearing?

Fri, 07 Mar 2025 00:00:00 -0000

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter, and Editor-in-Chief Nielsen Hobbs discuss the issues that dominated the Senate confirmation hearing for US Food and Drug Administration Commissioner nominee Martin Makary, including vaccines (1:03) and mifepristone (14:45), as well as several questions that were not asked (23:31). They also consider the potential impact of his answers on the agency. More On These Topics From The Pink Sheet Makary Plans To Review Mifepristone Data, Raising Concerns Of Abortion Pill Access Rollbacks: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/makary-plans-to-review-mifepristone-data-raising-concerns-of-abortion-pill-access-rollbacks-24NTRIXLKJD23OKNBB5Z7UAFL4/ Senators Scrutinize US FDA Commissioner Nominee Makary Over VRBPAC Cancellation: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/senators-scrutinize-us-fda-commissioner-nominee-makary-over-vrbpac-cancellation-HVW5VNH55ZFUPBL64BK2VNOYJA/ Science Vs. Politics: Hearing Could Reveal Makary’s Approach To Unusual Administration Involvement: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/science-vs-politics-hearing-could-reveal-makarys-approach-to-unusual-administration-involvement-LGWBJEWWNRCIXPVEJ4AEAJRLN4/

Grove AI and Grace, An Agentic AI For Clinical Trial Engagement

Fri, 07 Mar 2025 00:00:00 -0000

In Vivo spoke with Tran Le and Sohit Gatiganti, co-founders of Grove AI and developers of Grace, a voice-based agentic AI that streamlines clinical trial processes.

【3分で解説世界のファーマ】第23回トランプ関税製薬への影響は (Japanese-language podcast)

Fri, 07 Mar 2025 00:00:00 -0000

世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。今回取り上げた記事はこちら「As Trumps Ups The Ante On Tariffs, Reactions Are Mixed（邦訳：止まらぬトランプ関税措置　業界の反応は複雑化）」 URL:　 https://insights.citeline.com/scrip/business/manufacturing/as-trumps-ups-the-ante-on-tariffs-reactions-are-mixed-7WMIGZ3O5JHF7AJSICVLRUE3GY/ ※全文の閲覧には購読（有料）が必要です。世界の製薬ビジネスメディアScrip（スクリップ）とは？ https://www.citeline.com/ja-jp/products-services/commercialization/scrip

트럼프의 관세 인상에 대한 엇갈린 반응 (Korean-language podcast)

Thu, 06 Mar 2025 00:00:00 -0000

트럼프의 관세 조치에 따른 미국시장 영향과 글로벌 빅파마들의 반응에 대한 Scrip 기사를 요약한 내용입니다. https://insights.citeline.com/scrip/business/manufacturing/as-trumps-ups-the-ante-on-tariffs-reactions-are-mixed-7WMIGZ3O5JHF7AJSICVLRUE3GY/ Playlist: soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini

The Challenge Of Innovating In A Changing OTC Industry With AdverCheck’s James Walmsley

Mon, 03 Mar 2025 00:00:00 -0000

The consumer healthcare industry is changing. Companies are separating from their pharmaceutical parents and brands are shifting from therapeutic solutions to preventative health and wellness options. These shifts bring a number of challenges for OTC firms, notes AdverCheck managing director James Walmsley in the second part of his chat with HBW. For example, it is much more difficult to get science-backed claims for food supplements approved, he points out. With firms now also becoming standalone consumer health entities, there is no longer a direct pipeline of off-patent prescription medicines available for Rx-to-OTC switch, he observes. We may, therefore, see a new generation of switch-focused self-care companies and partnerships emerging. Keywords: Innovation, AdverCheck, OTC medicines, Consumer Health, Rx-to-OTC switch Timeline

Scrip's Five Must-Know Things - 3 March 2025

Mon, 03 Mar 2025 00:00:00 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 28 February 2025. In this episode: which big companies face the least LOE hit?; IPOs rise in 2024; Pfizer cuts last AAV gene therapy program; balance and focus suggested for globalizing Chinese firms; and Scrip Asks on therapeutic area advances. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-4RXPQH4B5NBJ3AM7SFMPROUJ2U/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Drug Fix: Laid Off US FDA Staff Called Back, Vaccine Adcomm Cancelled, Lilly’s Manufacturing Push

Fri, 28 Feb 2025 00:00:00 -0000

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Editor-in-Chief Nielsen Hobbs, as well as Medtech Insight Managing Editor Elizabeth Orr, discuss the US Food and Drug Administration’s decision to call back many workers that were laid off and the next steps for the Trump Administration’s effort to reduce the size of the federal government (:29), the FDA decision to cancel an upcoming Vaccines and Related Biological Products Advisory Committee meeting on strain selection for the 2025-2026 flu vaccine (12:42), and the motives for Eli Lilly’s plan to increase domestic manufacturing (23:18). More On These Topics From The Pink Sheet Drug Reviewers And Legal Staff Among Those Called Back to US FDA, But Why?: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/drug-reviewers-and-legal-staff-among-those-called-back-to-us-fda-but-why-YWONQYDHARESFLLY26YEP6RIHI/ DOGE-ing US FDA: Three Scenarios For What Comes Next: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/doge-ing-us-fda-three-scenarios-for-what-comes-next-XUDLPX3WNNH55JCHOMTOS2NXBA/ Breaking: US FDA Cancels Upcoming Adcomm Discussing 2025-2026 Flu Vaccine: https://insights.citeline.com/pink-sheet/vaccines/breaking-us-fda-cancels-upcoming-adcomm-discussing-2025-2026-flu-vaccine-AGBZQHYGZFHZLOK2PU5CCKBNK4/ Lilly $27Bn US Manufacturing Investment Linked To Trump’s Tariff, Tax Agenda: https://insights.citeline.com/pink-sheet/compliance/manufacturing/lilly-27bn-us-manufacturing-investment-linked-to-trumps-tariff-tax-agenda-FN55MQ3V75EU5J42TIYTFLTH4Q/

Scrip's Five Must-Know Things - 25 February 2025

Tue, 25 Feb 2025 00:00:00 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 21 February 2025. In this episode: 2025’S biggest launches; 2024 deal metrics declined; GSK’s meningococcal vaccine; Arcus’s kidney cancer results; and Novartis on its India hub. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-2Y543BULOJEOTHMZLB5ATXRVPU/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Why OTC Firms Should Care About Rx Advertising, With AdverCheck’s James Walmsley

Mon, 24 Feb 2025 00:00:00 -0000

UK law prohibits the advertising of prescription-only medicines. Nevertheless, some online pharmacies are marketing Rx drugs from “skinny jabs” to high strength eczema treatments, essentially selling prescription medicines directly to consumers, explains AdverCheck managing director James Walmsley. While regulators are cracking down on illegal practices, the growing market for prescription medicines is increasingly impinging on traditional consumer healthcare categories, Walmsley warns. In this episode of Over the Counter, we get to the bottom of this fascinating issue and outline what firms need to know.

Drug Fix: Understanding the US FDA Layoffs And Their Impact On Industry

Fri, 21 Feb 2025 00:00:00 -0000

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter, and Editor-in-Chief Nielsen Hobbs, as well as Medtech Insight Managing Editor Elizabeth Orr and HBW Insight Managing Editor Malcolm Spicer, discuss the most up-to-date information on the layoffs at the US Food and Drug Administration that were instituted by the Trump Administration (:42). They also consider the layoffs’ impact on the drug, device and consumer health divisions, including application review and facility inspections, as well as industry’s response to them (17:58). More On These Topics From The Pink Sheet US FDA Staff Cuts: Biopharma Industry Braces For Impact, But First Wants Clarity On Losses: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-staff-cuts-biopharma-industry-braces-for-impact-but-first-wants-clarity-on-losses-C45JIJX7IRD5FON2BNNKHTTBZU/ CMS Layoffs Broader Than Reports Indicate, Former Administrator Brooks-LaSure Says: https://insights.citeline.com/pink-sheet/advanced-technologies/cell-and-gene-therapies/cms-layoffs-broader-than-reports-indicate-former-administrator-brooks-lasure-says-A6XEKATFPRFXZCHSD7VDKO53HA/ Weekend US FDA Layoffs Cost Device Center Many AI And Digital Health Staffers: https://insights.citeline.com/pink-sheet/advanced-technologies/ai/weekend-us-fda-purge-costs-device-center-many-ai-and-digital-health-staffers-VSCWD67JAJARTP7S3EZYB6KSIQ/ US FDA Food Safety Leader Resigns In Protest Of White House-Ordered Layoffs: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-food-safety-leader-resigns-in-protest-of-white-house-ordered-layoffs-ZJSIV3VWTNBB7MPGPOV7TUWWJU/ FDA Cosmetics Office Braces For Agency-Wide Staff Cuts; MoCRA Implementation Likely Delayed: https://insights.citeline.com/hbw-insight/beauty/policy-and-regulation/fda-cosmetics-office-braces-for-agency-wide-staff-cuts-mocra-implementation-likely-delayed-5CNPONAL2JBGRIOVLTPSISLCFY/ PhRMA Still All In For Trump Despite Chaos Hitting US Health Sector: https://insights.citeline.com/pink-sheet/market-access/phrma-still-all-in-for-trump-despite-chaos-hitting-us-health-sector-MSNPGI66H5AABGVJVGG2MLNZIA/

Scrip's Five Must-Know Things - 18 February 2025

Tue, 18 Feb 2025 00:00:00 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 14 February 2025. In this episode: delayed take-off for M&A?; Bain to acquire Mitsubishi Tanabe; clinical trials to look out for; how to work with Trump; and mid-cap biopharma winners and losers. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-PYWFIZWE2FH2LIZUT4BDHGBZHQ/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Drug Fix: RFK’s First Actions, Pitch To Extend Current US FDA User Fee Agreement, More Trump Impacts

Fri, 14 Feb 2025 00:00:00 -0000

Pink Sheet Executive Editor Derrick Gingery, Editor-in-Chief Nielsen Hobbs, and special guest Michael McCaughan of Prevision Policy look at new Health and Human Services Secretary Robert F. Kennedy Jr.’s first assignment, a presidential commission on reducing chronic disease (:29), as well as former US Food and Drug Administration Commissioner Scott Gottlieb’s suggestion that industry extend the existing user fee program rather than negotiate a new agreement in the current political environment (13:30). They also discuss the impact of President Trump’s executive order mandating a reduction in force across the federal government on the US Food and Drug Administration and communications questions affecting the agency’s advisory committee schedule (25:16). More On These Topics From The Pink Sheet Commission Led By HHS Secretary Kennedy Will Probe ‘Threats’ To Children, Including Medicines: https://insights.citeline.com/pink-sheet/agency-leadership/commission-led-by-hhs-secretary-kennedy-will-probe-threats-to-children-including-medicines-Q5YF65T23JEOXDWQ7I72X556KQ/ Bracing For RFK At HHS: Vaccine Safety Commission Likely First Step: https://insights.citeline.com/pink-sheet/agency-leadership/bracing-for-rfk-at-hhs-vaccine-safety-commission-likely-first-step-O5XKOSVYYVE7RMQUAIHZ4I2OLY/ User Fees: Industry Should Push For Extension Of Current Agreement In Reconciliation Bill, Gottlieb Says: https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/user-fees-industry-should-push-for-extension-of-current-agreement-in-reconciliation-bill-gottlieb-says-YOWZW2CMSZA4BDP23MR2FLQJB4/ Could PDUFA VIII Align With Trump’s Efficiency Emphasis?: https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/could-pdufa-viii-align-with-trumps-efficiency-emphasis-5WGLRU6N2FG4XABILEMHBYDXYI/ US FDA Advisory Committee Freeze Raises Concerns Of Delayed, More Controversial Approvals: https://insights.citeline.com/pink-sheet/product-reviews/us-advisory-committees/us-fda-advisory-committee-freeze-raises-concerns-of-delayed-more-controversial-approvals-CWT2HOAQ3JBHNCMKSSOOXVAYYU/ ‘This Is Not Good For Business’: Trump’s Workforce Shakeups Could Harm Industry: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/this-is-not-good-for-business-trumps-workforce-shakeups-could-harm-industry-JJTMQ5RXOFDC7DQDVIZ3S2NJG4/

Podcast: JPM Tracked and Unpacked

Thu, 13 Feb 2025 00:00:00 -0000

Citeline’s expert panel of reporters and analysts unpack the biggest deals, trends, and innovations from the JP Morgan Healthcare Conference. Discover what these developments mean for you and the future of the industry in 2025 and beyond.

Scrip이 묻다... 2025년 제약바이오 산업의 미래는? 세계 정치 변화의 영향 (Korean-language podcast)

Wed, 12 Feb 2025 00:00:00 -0000

트럼프 미 대통령의 재당선과 지정학적 불안요소가 제약바이오 시장과 기업에 어떤 영향을 미칠까? Scrip의 전문가 설문조사 기사를 요약한 내용입니다. https://insights.citeline.com/scrip/scrip-asks/scrip-asks-what-does-2025-hold-for-biopharma-part-3-impacts-of-political-change-in-us-and-beyond-CKTDR3BC2JBU5O6MUHDAKXGXHU/ Playlist: soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini

Scrip's Five Must-Know Things - 10 February 2025

Mon, 10 Feb 2025 00:00:00 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 7 February 2025. In this episode: Novo outlines CagriSema strategy; Pfizer is back in the deal game; Vertex’s pain drug faces opportunities and headwinds; uncertain times for Korean pharma; and a view on women’s health at JPM. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-Y37SM5W2TZDXNE26O3W6E33TZE/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Getting Creative In Consumer Health, With All Creative’s Beverley Law

Mon, 10 Feb 2025 00:00:00 -0000

Creativity can sometimes be about discovering what in retrospect seems obvious, like shoes that are shaped to fit our feet, marketing expert Beverley Law tells HBW Insight in the first episode of this season’s Over the Counter podcast. But this often requires stepping out of established approaches and patterns of thinking, she points out, which tend to characterise innovation in the consumer health industry. Law offers some tips to help firms think outside the box, including being brave, benchmarking against the fast-moving consumer goods industry, and including regulatory experts much earlier on in the process.

Drug Fix: Kennedy’s Assurances To Gain HHS Nod, US FDA Coms Freeze Continues Thawing

Fri, 07 Feb 2025 00:00:00 -0000

Introduction: Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss the many commitments Robert F. Kennedy Jr. gave Sen. Bill Cassidy, R-LA, to secure his vote to move his Health and Human Services Secretary nomination to the Senate floor (:25). They also consider the slow restoration of some US Food and Drug Administration public communications and the impact of HHS postponing activities not deemed “mission-critical” (10:36). More On These Topics From The Pink Sheet HHS Nominee Kennedy’s Behind-The-Scenes Vaccine Reassurances Win Senate Swing Vote: https://insights.citeline.com/pink-sheet/vaccines/hhs-nominee-kennedys-behind-the-scenes-vaccine-reassurances-win-senate-swing-vote-F45HDCJQJJDIDKJOFXYODP6DJQ/ Kennedy Would Issue Trial Diversity Guidance, But Not Necessarily Roll Back All Anti-DEI Actions: https://insights.citeline.com/pink-sheet/r-and-d/clinical-trials/diversity-and-inclusion/kennedy-would-issue-trial-diversity-guidance-but-not-necessarily-roll-back-all-anti-dei-actions-4SDSMJ5V7NFPHKVUX5XYBMRMEE/ FDA Communications In Flux As HHS Assesses Mission-Critical Activities: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/fda-communications-in-flux-as-hhs-assesses-mission-critical-activities-H5UQ7BRSSZBVJDJBAXSVTDLIR4/ As US FDA Communications Freeze Thaws, Approvals Accumulate: https://insights.citeline.com/pink-sheet/product-reviews/approvals/as-us-fda-communications-freeze-thaws-approvals-accumulate-JA4WVLHMGJEZDHYB7LRNZAOYT4/

Harness Therapeutics CEO Talks Somatic Expansion for Neurodegeneration

Mon, 03 Feb 2025 00:00:00 -0000

Harness Therapeutics' CEO talked to In Vivo about the company's scientific strategy, and its plans for expansion and partnering in the neurodegeneration space.

Scrip's Five Must-Know Things

Mon, 03 Feb 2025 00:00:00 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 31 January 2025. In this episode: biopharma VC fundraising recovers; Daiichi Sankyo’s big year ahead; Akero’s promising MASH results; ADCs attract new investments in China; and Scrip Asks on AI and data science. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-D3ODXZGPURHZFJKT7MTVZ3AUWI/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things Release date: 27 January 2025

Drug Fix: President Trump’s Policies Begin Changing The US FDA, Kennedy’s Hill Hearings

Fri, 31 Jan 2025 00:00:00 -0000

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter, and Editor-in-Chief Nielsen Hobbs discuss the effect of Acting US Food and Drug Administration Commissioner Sara Brenner’s use of MAHA in her introductory memo (:35), the issues that emerged during MAHA founder and Health and Human Services Secretary nominee Robert F. Kennedy Jr.’s Senate confirmation hearings (7:22), return to office plans for senior FDA staff (14:27), and postponed meetings and other impacts of the Trump Administration’s freeze on agency communications (19:30). More On These Topics From The Pink Sheet US FDA Acting Commissioner Tells Staff She’s Ready To MAHA: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-acting-commissioner-tells-staff-shes-ready-to-maha-D3VJ2JORKVEC5MKJNBRNY2XAOE/ Beyond Vaccines: Kennedy’s Anti-Pharma Side On Display At Senate Hearings: https://insights.citeline.com/pink-sheet/agency-leadership/beyond-vaccines-kennedys-anti-pharma-side-on-display-at-senate-hearings-EATXNW5MNBATFDTUWSIDDO6RDA/ Will Republican Senator’s Concerns About Kennedy’s Vaccine Views Endanger Nomination?: https://insights.citeline.com/pink-sheet/vaccines/will-republican-senators-concerns-about-kennedys-vaccine-views-endanger-nomination-ZQMM3G6NIFAQ7NPS2WF6F22PFE/ Medicare Price Negotiation Will Continue Under Trump With Possible ‘Improvements’: https://insights.citeline.com/pink-sheet/geography/north-america/united-states/medicare-price-negotiation-will-continue-under-trump-with-possible-improvements-BD6JAB25KZDLXO7MCVDCTLEESE/ US FDA Senior Staff Return To Office In February, Next Steps for Schedule F Reclassification: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-senior-staff-return-to-office-in-february-next-steps-for-schedule-f-reclassification-ETI5TGY5XRACLA76GCYY2PEZ74/ US FDA Opioids Adcomm Postponed; Are Communications Freeze, Travel Ban To Blame?: https://insights.citeline.com/pink-sheet/product-reviews/us-advisory-committees/us-fda-opioids-adcomm-postponed-are-communications-freeze-travel-ban-to-blame-H4WQ4DLAJBD5HOZAWBCSRDBTIA/ Approvals The US FDA Is Not Talking About: A Communication Freeze Calendar: https://insights.citeline.com/pink-sheet/product-reviews/approvals-the-us-fda-is-not-talking-about-a-communication-freeze-calendar-DHS4X56LNNFELPXQ6JAZSGJMGA/

Datamonitor Healthcare Podcast: Epidemiology in the Age of Real World Data and AI

Fri, 31 Jan 2025 00:00:00 -0000

Summer Colling and Emma Wille speak with epidemiologists Ridwaan Ibrahim and Lucia Rodriguez-Garcia about the recent ISPOR conference. Ridwaan and Lucia discuss where they see new technologies like AI fitting into the epidemiology space as well as the advantages and disadvantages of using AI to analyze large volumes of real world data.

Scrip's Five Must-Know Things - 27 January 2025

Mon, 27 Jan 2025 00:00:00 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 24 January 2025. In this episode: semaglutide in 2027 Medicare price negotiations; J&J expects revenue growth despite challenges; Roche’s China Accelerator makes progress; Scrip Asks about the impact of political change; and Datroway’s US approval in breast cancer. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-3VZEWOJZWZHEPJGE6T2L4HOKPA/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Drug Fix: Concerns and Questions As Trump Administration Takes Control Of US FDA

Fri, 24 Jan 2025 00:00:00 -0000

Pink Sheet reporter and editors try to answer some emerging questions about the US Food and Drug Administration now that President Donald Trump has taken office. They discuss the FDA’s acting leadership (:43), an ongoing communications freeze (7:45), along with the hiring freeze and travel ban (20:49). They also discuss the impact of several executive orders on the US Centers for Medicare and Medicaid Services (26:23) and try to put the entire week’s events into perspective (33:40). Editor’s Note: This episode was recorded prior to Sara Brenner being officially named acting FDA commissioner, but the discussion about other aspects of the presidential transition still is relevant. More On These Topics From The Pink Sheet Who’s Running The US FDA? Interim Team May Not Have Assumed Control: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/whos-running-the-us-fda-interim-team-may-not-have-assumed-control-S5HIPYKBZNFY3J2VHNJRY4JDYQ/ Deciphering Trump’s Executive Order On Medicare, Medicaid Payment Models: https://insights.citeline.com/pink-sheet/market-access/government-payers/medicare/deciphering-trumps-executive-order-on-medicare-medicaid-payment-models-MEWAWGHDNVES3IHTJJUJNAZJVI/ US FDA’s Trump Transition Relatively Smooth, Except For Diversity, Equity Work: https://insights.citeline.com/pink-sheet/r-and-d/clinical-trials/diversity-and-inclusion/us-fdas-trump-transition-relatively-smooth-except-for-diversity-equity-work-V367EFJBVRGLBIVJ7VGWIYUSJ4/

Scrip's Five Must-Know Things - 20 January 2025

Mon, 20 Jan 2025 00:00:00 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 17 January 2025. In this episode: a look at JPM; J&J’s Intra-Cellular buy; how JPM Day 1 deals fit into BD strategy; Scrip asks about the global state of biopharma; and what will fuel M&A activity in India this year. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-JVFXFPYT4VFX5GEKYAVA55FOMU/ Playlist: https://soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Fauna Bio: Gleaning Therapeutic Insights From Animals

Mon, 20 Jan 2025 00:00:00 -0000

In Vivo speaks with Ashley Zender, CEO of Fauna Bio, a company using AI to identify drug targets based on natural disease resistance in animals. The company's $494m partnership with Eli Lilly is a testament to the value of their approach.

A “Game Changer” For The High-Risk MDS Patient Population

Fri, 17 Jan 2025 00:00:00 -0000

Juho Jalkanen, CEO of Faron Pharma, discusses the importance of addressing unmet medical needs in cancer through breaking treatment resistance and developing long-term solutions. In Vivo questions the current progress of their lead asset BEXMAB and its potential moving forward.

Drug Fix: US FDA And Trump’s Reforms, CDER Director Parting Comments, 2024 Approval Trends

Fri, 17 Jan 2025 00:00:00 -0000

Pink Sheet editors consider ex-FDA officials’ advice for the Trump Administration on implementing FDA reforms (:24), comments CDER Director Patrizia Cavazzoni made before her departure from the agency about wanting to release review documents for applications that received complete response letters (12:35), and diverging trends between CDER and CBER novel application approvals (21:53). More On These Topics From The Pink Sheet Trump’s US FDA Reforms Need Center Director, Staff Support To Succeed, Former Leaders Say: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/trumps-us-fda-reforms-need-center-director-staff-support-to-succeed-former-leaders-say-VCCGXSBJGZGXPHEYJFAHIHEI7A/ Exit Interview: US FDA’s Patrizia Cavazzoni Says CDER Staff In ‘Best Place Possible’: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/exit-interview-us-fdas-patrizia-cavazzoni-says-cder-staff-in-best-place-possible-IN6GTBFEJZDSNOI4T23CRYK7OY/ Innovation Drives Divergence: US FDA Drugs and Biologics Centers Follow Own Trajectories: https://insights.citeline.com/pink-sheet/pink-sheet-perspectives/innovation-drives-divergence-us-fda-drugs-and-biologics-centers-follow-own-trajectories-MDZ5DSCKKNEYPF6PVTXAMFHGF4/ US FDA’s Median Review Time Remains Less Than One Year Despite Swell Of Missed Goal Dates: https://insights.citeline.com/pink-sheet/pink-sheet-perspectives/us-fdas-median-review-time-remains-less-than-one-year-despite-swell-of-missed-goal-dates-VIEE6AVOQRGMZNKB53B52GPQG4/ Clocking The Speed Of US FDA 2024 Novel Approvals: https://insights.citeline.com/pink-sheet/pink-sheet-perspectives/clocking-the-speed-of-us-fda-2024-novel-approvals-3HT7CAIO4VBJDIJZVGBHLAUCSY/

Scrip's Five Must-Know Things - 14 January 2025

Tue, 14 Jan 2025 00:00:00 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 10 January 2025. In this episode: key themes for JPM; 2024 launches a breakout for liver disease; obesity drug readouts this year; IgA nephropathy snapshot; and only half of 2024 launches were from big pharma. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-SV3WFD7NQJEW3FDTUDZICD2IKE/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Drug Fix: CDER Director Retires, US FDA Guidance ‘Blizzard,’ Rare Pediatric Disease Program Hangs On

Fri, 10 Jan 2025 00:00:00 -0000

Pink Sheet editors discuss Center for Drug Evaluation and Research Director Patrizia Cavazzoni’s surprising retirement announcement (:32), the importance of the large bolus of guidance documents that the FDA released 6 January (12:42), and the FDA’s decision to continue reviewing and granting rare pediatric disease designations even though the program lapsed (18:48). More On These Topics From The Pink Sheet Digging Through The US FDA Guidance Blizzard: https://insights.citeline.com/pink-sheet/legislation/elections/digging-through-the-us-fda-guidance-blizzard-TR6LKKXLZ5C5ZG5HUYDJ6XJO3M/ Artificial Intelligence: US FDA Outlines 7 Steps To Establishing Model Credibility: https://insights.citeline.com/pink-sheet/advanced-technologies/ai/artificial-intelligence-us-fda-outlines-7-steps-to-establishing-model-credibility-ZZTAXYUP3BDKPKLF6CVECQYO7M/ Accelerated Approval: US FDA Explains When A Confirmatory Trial Is ‘Underway’: https://insights.citeline.com/pink-sheet/product-reviews/post-marketing-regulation-and-studies/accelerated-approval-us-fda-explains-when-a-confirmatory-trial-is-underway-YP2DRCCKFBHJHOJ7K7LKH2AX4U/ Off-Label Communications: US FDA Clarifies Safe Harbor For Firm-Generated Presentations: https://insights.citeline.com/pink-sheet/compliance/marketing-and-advertising/off-label-communications-us-fda-clarifies-safe-harbor-for-firm-generated-presentations-DEDRJWWNWBAUJPTEVI2GLHGI4M/ US FDA Still Reviewing Rare Pediatric Disease Designation Requests Despite Program Lapse: https://insights.citeline.com/pink-sheet/rare-diseases/us-fda-still-reviewing-rare-pediatric-disease-designation-requests-despite-program-lapse-EJSANI3SL5GATG66ZMVYVCME4E/

2025년 JP모건 헬스케어 컨퍼런스의 주요 주제는? (Korean-language podcast)

Thu, 09 Jan 2025 00:00:00 -0000

트럼프 대통령의 취임 직전 열리는 2025년 JP모건 헬스케어 컨퍼런스에서 라이센스딜 및 M&A 뿐 아니라 미국 정치와 정책도 주목 받을 것이라는 Scrip 기사의 요약입니다. https://insights.citeline.com/scrip/conferences/jp-morgan/jpm-2025-deals-politics-and-parties-to-welcome-a-new-year-for-pharma-5XBXOFPQMNB3ZBWVSWIIY5Y7IM/ Playlist: soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini

Pre-JPM Biotech Dealmaking Roundtable

Tue, 07 Jan 2025 00:00:00 -0000

As we enter 2025, In Vivo convened a group of biotech executives for a wide-ranging conversation about dealmaking this year and the challenges and opportunities for companies in the cardiometabolic, longevity, radiopharmaceuticals and cancer spaces. Essential listening before JPM.

The Future of Immunotherapy

Mon, 06 Jan 2025 00:00:00 -0000

In this episode of the In Vivo podcast, Harvard immunologist and co-founder of early-stage biotech Corner Therapeutics, Jonathan Kagan, talks about harnessing the power of the innate immune system by weaponizing dendritic cells and creating immunotherapies that are safer and more durable.

Digital Health Roundup: 2025 Will See More AI/GenAI Adoption In Medtech, FDA’s Digital Health Push

Mon, 06 Jan 2025 00:00:00 -0000

In this week’s Digital Health Roundup, Medtech Insight’s Marion Webb brings highlights from Deloitte’s 2025 Life Sciences Outlook Report with medtech leaders’ forecasting significant investments in AI/GenAI. Brian Bossetta talks about the US FDA’s newly formed Digital Health Advisory Committee. Elizabeth Orr highlights the pros and cons of penetration testing for cybersecurity and talks about the US FDA’s final guidance on pre-determined change control plans. Natasha Barrow highlights UK MHRA's AI Airlock Pilot program and MANIFEST. Related Links: https://insights.citeline.com/medtech-insight/pickleball-smart-homes-brain-games-caregiving-agetech-take-centerstage-at-aarps-ces-2025-presence-CIGK5RS7EVG2XH3XBQSUYDQXI4/

An Insight into NASH

Tue, 31 Dec 2024 00:00:00 -0000

Emma and Summer meet with Datamonitor Healthcare analyst Ken Hoang, to discuss the non-alcoholic steatohepatitis (NASH) treatment market

올해의 Top 5 글로벌 제약 뉴스 (Korean language podcast) - 27 December 2024

Fri, 27 Dec 2024 00:00:00 -0000

Scrip이 선정한 2024년의 Top 5 글로벌 제약바이오 뉴스입니다. https://insights.citeline.com/scrip/business/deals/the-top-five-pharma-stories-of-2024-GSROXP3WAZBWXGV4YP6VJML3YY/ Playlist: soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini

Scrip's Five Must-Know Things - 23 December 2024

Mon, 23 Dec 2024 00:00:00 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 20 December 2024. In this episode: Pfizer’s 2025 policy outlook; made in China blockbuster elusive; Vertex’s pain plans; Q3’s top 10 drugs; and sickle cell disease at ASH. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-JGJEXCVFMVCMFKUYS6K32YZJ34/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

The Future Of eClinical Technology

Thu, 19 Dec 2024 00:00:00 -0000

The Future Of eClinical Technology by Citeline

Five Must-Know Things - 16 December 2024

Mon, 16 Dec 2024 00:00:00 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 13 December 2024. In this episode: a snapshot of the atopic dermatitis market; Bill Burns profile; GSK’s Blenrep makes a comeback; CML results at ASH; and what’s driving optimism on India. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

The Generics Bulletin Podcast: Highlights Of 2024

Mon, 16 Dec 2024 00:00:00 -0000

Generics Bulletin's editorial team discusses key topics from the year, including the latest rankings of the GB Top 50, Amgen's surprise launch of a US Eylea biosimilar, the EU's Urban Waste Water Treatment Directive and supply-chain issues for the off-patent sector.

The Role of Site Networks & Why They Matter

Tue, 10 Dec 2024 16:18:19 -0000

Learn how utilizing a site network can improve clinical trial efficiency and scalability, data quality, patient access and recruitment, resource optimization, and regulatory compliance. Discover more about speeding clinical trials with the use of site networks.

Datamonitor Healthcare Podcast: Psychedelic Symposium at the University of Wisconsin-Madison

Tue, 10 Dec 2024 00:00:00 -0000

Summer Colling speaks with Emma Wille about the Psychedelic Symposium at the University of Wisconsin-Madison and what the future of psychedelic therapeutics could look like.

Scrip's Five Must-Know Things - 10 December 2024

Tue, 10 Dec 2024 00:00:00 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 6 December 2024. In this episode: Zepbound bests Wegovy; Novartis and PTC’s Huntingdon’s deal; Vabysmo hopes to ride new listing, data in Asia; Leo Pharma gains momentum; and Immunic’s hopes for MS drug. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-FU2EL35AAJBGLIK4EL7KVQRAGU/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Arialys Therapeutics: Treating Autoimmune Neuropsychiatric Diseases

Mon, 09 Dec 2024 00:00:00 -0000

In this episode of the In Vivo podcast, Peter Flynn, CEO of Arialys Therapeutics, discusses the exciting field of autoimmune neuropsychiatry and the company’s monoclonal antibody, which it is investigating for the treatment of a rare condition called anti-NMDA receptor encephalitis and potentially other indications.

Drug Fix: COVID-19 Vaccine EUAs In Danger, DOGE And US FDA, New 340B Rebate Pricing Models

Fri, 06 Dec 2024 00:00:00 -0000

Pink Sheet reporter and editors discuss potential threats to the COVID-19 vaccine pediatric indications under the Trump Administration (:24), the DOGE commission’s search for spending cuts and its impact on the FDA (12:52), as well as a new 340B rebate pricing model that some pharma companies are implementing to contain the program’s costs (22:52). More On These Topics From The Pink Sheet Pediatric COVID Shots, Still Under EUA, Would Be Vulnerable In Anti-Vax HHS: https://insights.citeline.com/pink-sheet/vaccines/pediatric-covid-shots-still-under-eua-would-be-vulnerable-in-anti-vax-hhs-UWJRLYQUCJEWTLC42IFR7X2XFY/ Can US FDA Dodge DOGE? Return To Office Mandate May Be Biggest Hit: https://insights.citeline.com/pink-sheet/legislation/elections/can-us-fda-dodge-doge-return-to-office-mandate-may-be-biggest-hit-5G5SYM3ACNAKLHSSHQL32KJN5Y/ 340B Plan B: Pharma Pivots To Rebate Pricing Model After Pharmacy Restrictions Fall Short: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/340b-plan-b-pharma-pivots-to-rebate-pricing-model-after-pharmacy-restrictions-fall-short-M5DTVTFXVZA37IQ6CXMTDW4QMI/

November 2024 Datamonitor Healthcare Podcast: Bispecific Antibodies in Oncology

Thu, 05 Dec 2024 00:00:00 -0000

Emma and Summer meet with oncology analysts Neha Anand and David Dahan, to discuss an emerging class of drugs: bispecific antibodies.

Treating Rare Diseases With tRNA

Wed, 04 Dec 2024 00:00:00 -0000

In this episode of the In Vivo podcast, Michelle Werner, CEO of Alltrna, discusses using tRNA as a therapeutic modality for rare diseases, including those stemming from nonsense mutations.

Conference Catch-Up: BIO-Europe 2024

Tue, 03 Dec 2024 00:00:00 -0000

Biopharma is evolving through collaboration, early-phase deal-making and innovation in precision medicine and AI. At BIO-Europe, Norstella's subject matter experts explored key trends shaping the industry, from market access strategies to sustaining growth through partnerships. In this episode, Izabela Chmielewska, Kevin Grogan, and Natasha Choukkar discuss takeaways – from advancing personalized treatments to tackling the patent cliff – highlighting how Norstella empowers organizations to navigate complexity and drive innovation.

Scrip's Five Must-Know Things - 2 December 2024

Mon, 02 Dec 2024 00:00:00 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 29 November 2024. In this episode: Marks on Trump’s threat to FDA; Amgen’s Phase II MariTide data lack clarity; Roche’s Poseida buyout; Roche’s CMO on his biotech lessons; and what Trump 2.0 might mean for India. https://insights.citeline.com/scrip/podcasts/quick-listen-scrips-five-must-know-things-GIXQTTFOANHRLAWTJEMLY6Z2LI/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Scrip Awards Podcast, Ep2: 2024 Awards Preview & Verona Pharma Interview

Thu, 28 Nov 2024 00:00:00 -0000

A preview of the 2024 Scrip Awards and an interview with last year’s Executive of the Year, David Zaccardelli, CEO of Verona Pharma.

Drug Fix: Trump’s Potential Impact On FDA User Fees, Dr. Oz’s Potential Impact On CMS

Fri, 22 Nov 2024 00:00:00 -0000

Pink Sheet reporter and editors discuss concerns that the incoming administration could try to influence the upcoming FDA user fee reauthorization (:30), as well as the changes Dr. Mehmet Oz, President-elect Donald Trump’s controversial selection of to run the US Centers for Medicare and Medicaid Services, could impose if confirmed (22:35). #pharma #business More On These Topics From The Pink Sheet Trump’s US FDA User Fee Cycle: ‘An Underappreciated Threat’: https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/trumps-us-fda-user-fee-cycle-an-underappreciated-threat-GVVSHUIRXBDOHDLWQXHSLC2U4A/ Medicare Price Negotiation Under CMS Chief Oz May See Early 2025 Test: https://insights.citeline.com/pink-sheet/agency-leadership/medicare-price-negotiation-under-cms-chief-oz-may-see-early-2025-test-UOROAUBSE5CWJC65XK6Q5I37SE/ CMS Administrator Nominee Oz Is ‘Communicator’ In Sync With RFK’s Healthy Living Focus: https://insights.citeline.com/pink-sheet/agency-leadership/cms-administrator-nominee-oz-is-communicator-in-sync-with-rfks-healthy-living-focus-CHOJUI4DWVCWRFQMBZXCQYAGB4/

Scrip's Five Must-Know Things - 25 November 2024

Fri, 22 Nov 2024 00:00:00 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 22 November 2024. In this episode: Novo’s semaglutide looks good in NASH; J&J’s psoriasis drug hits multiple Phase III goals; NASH competition gets serious; China dominates APAC and increasingly global trials; and why has M&A decreased in 2024. https://insights.citeline.com/scrip/podcasts/quick-listen-scrips-five-must-know-things-YDQU2ROM3JAXDD72TMXMOYZGGE/ Link to APAC Clinical Trials White Paper: https://www.citeline.com/en/resources/exploring-the-asia-pacific-clinical-trials-landscape Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Scrip's Five Must-Know Things - 18 November 2024

Mon, 18 Nov 2024 00:00:00 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 15 November 2024. In this episode: muscling into the obesity market; AbbVie’s schizophrenia failure; Bayer will not take risky bets; generally strong Q2 for Japanese majors; and AstraZeneca juggles China and growth questions. https://insights.citeline.com/scrip/podcasts/quick-listen-scrips-five-must-know-things-6XHHXGKMXRBV7MMKZE2NJRDG6A/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Drug Fix: Trump Picks Robert F. Kennedy Jr. To Lead HHS, How Could He Disrupt FDA?

Fri, 15 Nov 2024 00:00:00 -0000

Pink Sheet reporter and editors, and guest Michael McCaughan of Prevision Policy, continue the discussion of Donald Trump’s potential impact on the FDA, including how Robert F. Kennedy Jr. could change the agency as head of HHS (:37), whether lasting changes are coming to the FDA (13:00), and Commissioner Robert Califf’s request that industry help preserve the agency status quo (18:18). More On These Topics From The Pink Sheet Speed Of Novel Approvals In Jeopardy As RFK Jr. Lands US HHS Secretary Nod: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/speed-of-novel-approvals-in-jeopardy-as-rfk-jr-lands-us-hhs-secretary-nod-PBKQI3K2XBHK5F53ZBHRD6VX2Q/ Three Ways Trump Could Disrupt The US FDA: https://insights.citeline.com/pink-sheet/legislation/elections/three-ways-trump-could-disrupt-the-us-fda-5KPABNKMKVBWNMFBQGU6H6ZWKU/ Industry Support Key To US FDA’s Prospects Under Trump, Califf Says: https://insights.citeline.com/pink-sheet/legislation/elections/industry-support-key-to-us-fdas-prospects-under-trump-califf-says-73IBZRFLQVEERACL64N74IK5GM/ Republican Sweep Creates Smoother Path For Biopharma Policy Priorities: https://insights.citeline.com/pink-sheet/legislation/elections/republican-sweep-creates-smoother-path-for-biopharma-policy-priorities-R2UH6ULEN5DKHOOV3KGYSMSETE/ Anticipation And Trepidation About Trump’s Election Rise: https://insights.citeline.com/pink-sheet/legislation/elections/anticipation-and-trepidation-about-trumps-election-rise-YTCHNKQW4VA3PPY3GBF3BQLAOQ/

Scrip M&A Podcast: Why Did Biopharma M&A Metrics Decline During Q2 And Q3

Thu, 14 Nov 2024 00:00:00 -0000

Scrip senior writer Joseph Haas discusses recent merger-and-acquisition activity in the biopharma sector with Gerardo Ubaghs, CFO of Frontier Medicines, and Jason Silvers, CFO of Generate Biomedicines. The panel looks at why M&A activity metrics declined during both the second and third quarters despite a strong start to the year and apparent positive conditions for dealmaking, as well as what impact the US election results could have on M&A going forward.

Scrip's Five Must-Know Things - 11 November 2024

Mon, 11 Nov 2024 00:00:00 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 8 November 2024. In this episode: what Trump might mean for pharma; Novo’s semaglutide hits mark in NASH; AstraZeneca leads the way in clinical trials; Viking’s weight loss data excite; and how to speed up MLR reviews. https://insights.citeline.com/scrip/quick-listen-scrips-five-must-know-things-D4FI3E5BCNF2HNIP6TPK5KQ2A4/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Using AI To Predict Our Immune Responses

Mon, 11 Nov 2024 00:00:00 -0000

In the latest episode of the In Vivo podcast, Noam Solomon, co-founder and CEO of Israeli-American biotech Immunai explains how his company is mapping the immune system and using AI to predict individual immune responses to drugs. Noam also discusses the company's own acquisitions, partnerships, the differences between innovation and invention, artificial biomedical intelligence (ABI) and barriers to personalized medicine.

Conference Catch-Up: Navigating the Evolving CDMO Landscape

Sun, 10 Nov 2024 00:00:00 -0000

Contract development and manufacturing organizations (CDMOs) are reshaping pharmaceutical production, playing a pivotal role in supply chain stability and driving innovation. In today’s fast-evolving environment, CDMOs help life sciences companies enhance speed, flexibility, and efficiency, which ultimately advances access to life-saving therapies. Norstella provides tailored insights, tools, and intelligence solutions to support this progress, empowering companies to make informed decisions and optimize their manufacturing partnerships. This year at CPHI Milan, our team observed key industry trends, including innovations to strengthen supply chains and enhance sustainable practices. At Citeline’s (a Norstella company) 11th Annual Global Generics & Biosimilars Awards, we also celebrated excellence in the generics sector. Following the conference, Andrea Charles, VP of custom content at Norstella, and Andrew Warmington, Citeline’s manufacturing editor, joined Izabela Chmielewska, managing editor of custom content, to discuss major takeaways – from the BIOSECURE Act’s influence on global operations to advancements in biomanufacturing. Together, they explored how Norstella and Citeline drive solutions to streamline the journey from pipeline to patient.

Drug Fix: How Will Trump’s Second Term Impact The US FDA?

Fri, 08 Nov 2024 00:00:00 -0000

Pink Sheet reporter and editors discuss potential changes that the incoming Trump Administration could make on the FDA, as well as worries about political interference in decision-making, and policy and staffing changes. More On These Topics From The Pink Sheet US FDA’s Drug Approval Norms Could Be Upended In Second Trump Term: https://insights.citeline.com/pink-sheet/legislation/elections/us-fdas-drug-approval-norms-could-be-upended-in-second-trump-term-ICH6FUN4OBHRJPN4QFJ4OPLHNU/ Warp Speed For All And A Boost For Small Biotechs In Trump’s Second Term, Ex-Official Says: https://insights.citeline.com/pink-sheet/legislation/elections/warp-speed-for-all-and-a-boost-for-small-biotechs-in-trumps-second-term-ex-official-says-DA3BUPKEWVGVNDEPG6JMVLV7UI/ With Trump’s Return, Pharma Trades Disagreeable Knowns For Uncertainty: https://insights.citeline.com/pink-sheet/legislation/elections/with-trumps-return-pharma-trades-disagreeable-knowns-for-uncertainty-N7ZMT6QOEZEUDEXOROKXAZBP6E/ FTC Under Trump Likely to Maintain PBM Focus But M&A Oversight May Moderate: https://insights.citeline.com/pink-sheet/legislation/elections/ftc-under-trump-likely-to-maintain-pbm-focus-but-ma-oversight-may-moderate-H3XQ4S3YJBDSBK2NIDZFM4ZQ34/

Digital Health Roundup: GE HealthCare On AI At HLTH; EU AI Act, Click Therapeutics

Thu, 07 Nov 2024 00:00:00 -0000

In this week’s Digital Health Roundup, Medtech Insight’s Marion Webb talks about her interview with GE HealthCare’s chief AI officer Parminder Bhatia at HTLH on his vision for AI in health care. Natasha Barrow discusses her interview with Owkin on the EU AI Act and highlights Click Therapeutics’ latest clinical results.

Scrip's Five Must-Know Things - 5 November 2024

Tue, 05 Nov 2024 00:00:00 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 1 November 2024. In this episode: Lilly plans DTC tirzepatide ads; Pfizer’s Bourla defends strategy; expert views from BioFuture; China retains attractions for some; and AbbVie’s Aliada acquisition. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

【3分で解説世界のファーマ】第22回 AD治療、費用対効果に悩む英国 (Japanese-language podcast)

Tue, 29 Oct 2024 00:00:00 -0000

世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。今回取り上げた記事はこちら「Déjà Vu In England: Lilly’s Alzheimer’s Drug Kisunla Gets MHRA Yes, But NICE Says No（邦訳：アルツハイマー治療薬ケサンラ承認で議論再び、薬価負担に悩む英国）」 URL:　 https://insights.citeline.com/pink-sheet/geography/europe/united-kingdom/deja-vu-in-england-lillys-alzheimers-drug-kisunla-gets-mhra-yes-but-nice-says-no-OX4YRPW4AFAYXAQVANZSSHURP4/ ※全文の閲覧には購読（有料）が必要です。世界の製薬ビジネスメディアScrip（スクリップ）とは？ https://www.citeline.com/ja-jp/products-services/commercialization/scrip

Scrip's Five Must-Know Things - 28 October 2024

Mon, 28 Oct 2024 00:00:00 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 25 October 2024. In this episode: Merck & Co’s Modifi acquisition; scenarios for new obesity drugs; Astellas gets US approval for claudin drug Vyloy; iTeos builds TIGIT lead; and execs discuss AI in clinical trials. https://insights.citeline.com/scrip/quick-listen-scrips-five-must-know-things-YMAHSAK2FBBKPIPNLZGPGHWPSQ/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Conference Catch-Up: The Rise of Digital Therapeutics (Part 2)

Sat, 26 Oct 2024 00:00:00 -0000

Health technologies are revolutionizing the ways in which life sciences organizations develop and deliver life-saving treatments to patients. In particular, digital therapeutics have become a prominent area of focus due to their potential to improve outcomes while reducing patient burden. Norstella continues to be proponent for these innovative technologies, partnering with organizations to launch their digital therapeutics products to market both seamlessly and with the patient in mind. That being said, we always stay up to date with the evolving landscape by attending meetings that bring together decision-makers with diverse expertise and fresh perspectives. LSX World Congress USA, which took place between September 11-12, 2024 in Boston, MA, addressed the complex investment, partnership, and innovation aspects of digital therapeutics. After attending the conference, Janelle Hart, managing editor, custom content at Citeline, sat down with principal and head of Digital Health & Access Innovation Strategy Tony Shi and consultant Eric Boyda from The Dedham Group, a Norstella company, to explore key takeaways from the meeting, what the future holds for digital therapeutics, and how Norstella and the Dedham Group are making strides in this sector to smooth the path from pipeline to patient. To listen to part 1 of this podcast, go to this link: https://soundcloud.com/citelinesounds/lsx-world-congress-usa-key-takeaways?si=6fa75aae9d7f45febcfe0bb6762a62aa&utm_source=clipboard&utm_medium=text&utm_campaign=social_sharing For more information on Norstella’s capabilities as a healthcare technology partner, visit: https://www.norstella.com/ To learn more about the Dedham Group, contact Tony or Eric at: tony.shi@norstella.com or eric.boyda@norstella.com

October 2024 Datamonitor Healthcare Podcast: Insights from ESMO

Mon, 21 Oct 2024 13:40:29 -0000

Emma and Summer meet with oncology analysts Neha Anand, Anna Simmons, and Nkiru Ibeanu, to share insights from the European Society of Medical Oncology (ESMO) conference.

Scrip's Five Must-Know Things - 21 October 2024

Mon, 21 Oct 2024 02:40:27 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 18 October 2024. In this episode: J&J looks to Tremfya as Stelara declines; Pfizer’s Hympavzi may find hemophilia B niche; big pharma’s cell and gene therapy realities; M&A took a holiday in Q3; and last rites for Sanofi’s RIPK1 drug. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-CMKHTUFVBBDQ3DSTX3KJALGCQI/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Drug Fix: SubQ Drugs And Price Negotiations, GLP-1s In Court, US FDA Approach To Black Box AI

Fri, 18 Oct 2024 19:18:30 -0000

Pink Sheet reporter and editors discuss an emerging pharma strategy to avoid Medicare price negotiations (:25), legal wrangling related to compounding GLP-1 drugs for obesity and diabetes (14:20), and the varying opinions of FDA officials on the acceptability of artificial intelligence models that are not fully explainable (29:08) #pharma #business More On These Topics From The Pink Sheet Keytruda, Opdivo SubQ Conversions Cloud Near-Term Medicare Negotiation Savings Forecasts: https://insights.citeline.com/pink-sheet/keytruda-opdivo-subq-conversions-cloud-near-term-medicare-negotiation-savings-forecasts-BJNQCECWVNESHGCKNPJSKVIH4I/ GLP-1s: Compounders Get Temporary Reprieve But US FDA May Be Building Stronger Case: https://insights.citeline.com/pink-sheet/legalandip/litigation/glp-1s-compounders-get-temporary-reprieve-but-us-fda-may-be-building-stronger-case-2SJVLIMS5FDERNWA7UQV3IM7JM/ US FDA Opinions Vary On AI’s Black Box Issues. Will Uncertainty Follow?: https://insights.citeline.com/pink-sheet/advanced-technologies/ai/us-fda-opinions-vary-on-ais-black-box-issues-will-uncertainty-follow-PPMN3R3FJ5BTZOXWDFHPHZVLNQ/

빅파마가 직면한 세포유전자 치료제 시장의 현실 (Korean-language podcast)

Thu, 17 Oct 2024 00:08:59 -0000

빅파마들은 세포유전자 치료제를 출시하면서 이러한 치료의 비용과 복잡성이라는 현실적인 문제에 직면해 있습니다. 최근 개최된 메사 세포유전자 회의를 취재한 Scrip 기사를 요약한 내용입니다. https://scrip.citeline.com/SC151041/Big-Pharma-Faces-Cell-And-Gene-Therapy-Market-Realities Playlist: soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini

China Biopharma Podcast - 16 October 2024 (Chinese language)

Wed, 16 Oct 2024 04:22:46 -0000

Dexter Yan回顾了他在国庆长假前和阿斯利康全球执行副总裁-生物制药研发负责人Sharon Barr的采访。此外，本期播客迎来了Citeline Insights团队在上海的新成员、资深记者Xu Hu。她分享了先为达生物伊诺格鲁肽的最新III期临床数据，以及中国律师对美国生物安全法案影响的分析。

Scrip's Five Must-Know Things - 15 October 2024

Tue, 15 Oct 2024 02:20:06 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 11 October 2024. In this episode: making cell and gene therapies more accessible; Roche’s obesity plans; Biosecure and Indian firms; IPOs begin to recover; and Nxera looks to the future. https://scrip.citeline.com/SC151048/Quick-Listen-Scrips-Five-MustKnow-Things Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Drug Fix: Inside Medicare Price Negotiations, New US FDA Vaccine Pathway

Fri, 11 Oct 2024 17:45:46 -0000

Introduction: Pink Sheet reporter and editors discuss experts’ experience helping drug sponsors negotiate prices with CMS (:33) and the FDA’s proposal for a new pathway to update vaccines before a pandemic is declared (12:02). More On These Topics From The Pink Sheet: Perspectives From The Front Lines: Navigating The First Round Of Medicare Price Negotiation: https://pink.citeline.com/PS155353/Perspectives-From-The-Front-Lines-Navigating-The-First-Round-Of-Medicare-Price-Negotiation US FDA Proposes New ‘Inter-Pandemic’ Pathway For Updating Flu Vaccines: https://pink.citeline.com/PS155345/US-FDA-Proposes-New-Inter-Pandemic-Pathway-For-Updating-Flu-Vaccines US FDA Advisors Urge Faster Movement, mRNA Consideration, In Updating Pandemic Flu Vaccines: https://pink.citeline.com/PS155358/US-FDA-Advisors-Urge-Faster-Movement-mRNA-Consideration-In-Updating-Pandemic-Flu-Vaccines

Q&A Session on Psoriasis in Pediatric Patients with Dr. Valerie Welch

Fri, 11 Oct 2024 12:41:17 -0000

Join us for a discussion on pediatric psoriasis and the importance of collaboration across specialties to improve treatment outcomes.

COPD Treatment Strategies: Q&A with Dr. Kenneth Chinsky

Fri, 11 Oct 2024 12:12:55 -0000

Join us for a discussion on COPD and inhaler choice.

Noticing Neffy – A ‘Transformative Treatment’ For Type 1 Allergies

Tue, 08 Oct 2024 08:17:56 -0000

Richard Lowenthal, co-founder, and CEO of ARS Pharma, highlights the crucial unmet need for needle-free injections. Challenging issues posed by current epinephrine injectors, In Vivo questions the current and future progression of Neffy.

Alpha-Synuclein Testing Comes of Age

Fri, 04 Oct 2024 14:55:36 -0000

In the latest episode of the In Vivo podcast, Russ Lebovitz, the co-founder and scientist behind Amprion, a diagnostics company, discusses the role of alpha-synuclein misfolding in neurodegenerative diseases and how early alpha-synuclein detection has the potential to mitigate the impacts of diseases ranging from Parkinson's disease to Lewy body dementia.

Q&A Session: PIK3CA Mutations and Breast Cancer

Thu, 03 Oct 2024 15:36:08 -0000

Join us for an informative discussion about PIK3CA testing and treatment with Dr. Neil Iyengar

Conference Catch-Up: LSX World Congress USA 2024

Wed, 02 Oct 2024 20:23:04 -0000

Discover the game-changing insights from the LSX World Congress USA! Join Janelle Hart, Managing Editor at Citeline, a Norstella Company, as she explores the key takeaways from the LSX World Congress USA meeting. In this episode, Janelle sits down with Tony Shi, Principal and Head of Digital Health and Access Innovation Strategy, and Eric Boyda, Consultant at The Dedham Group, to unpack the insights from this two-day event that brought together the brightest minds in biotech, medtech, and healthtech in Boston. Discover the challenges and opportunities shaping the future of healthcare technology, from groundbreaking innovations to strategic investments and transformative partnerships. Tune in now for exclusive insights and expert analysis that you won’t want to miss!

The Future Of Drug R&D Is Self-Driving

Mon, 30 Sep 2024 14:38:30 -0000

In the latest episode of the In Vivo podcast, Alan Aspuru-Guzik, a pioneer in chemical engineering who holds many positions, talks about how he is folding in robotic automation, generative AI and quantum computing in his self-driving lab.

Drug Fix: Pfizer Pulls Sickle Cell Drug, ODAC Calls Back Approved Products, New AAM CEO

Fri, 27 Sep 2024 16:50:09 -0000

Pink Sheet reporters and editors discuss Pfizer’s abrupt decision to withdraw Oxbryta (:32), the US FDA’s Oncologic Drugs Advisory Committee bringing sponsors of approved products back to discuss labeling changes while competitors are pending (10:46), and the new CEO of a generic industry trade association (27:34). More On These Topics From The Pink Sheet Pfizer Withdraws Oxbryta, But Overall Market Impact May Be Limited: https://pink.citeline.com/PS155302/Pfizer-Withdraws-Oxbryta-But-Overall-Market-Impact-May-Be-Limited EMA Discusses Fatal Events That Prompted Pfizer To Pull Oxbryta From Global Markets: https://pink.citeline.com/PS155296/EMA-Discusses-Fatal-Events-That-Prompted-Pfizer-To-Pull-Oxbryta-From-Global-Markets New US FDA Adcomm Trend: Approved Cancer Meds Get Another Look When Competitors Coming: https://pink.citeline.com/PS155285/New-US-FDA-Adcomm-Trend--Approved-Cancer-Meds-Get-Another-Look-When-Competitors-Coming All Comers No More? US FDA AdComm Supports PD-L1 Threshold In Esophageal, Gastric Cancer: https://pink.citeline.com/PS155300/All-Comers-No-More-US-FDA-AdComm-Supports-PDL1-Threshold-In-Esophageal-Gastric-Cancer Pazdur Calls For 'Kumbaya’ To Standardize ImmunoOncology Biomarkers: https://pink.citeline.com/PS155298/Pazdur-Calls-For-Kumbaya-To-Standardize-ImmunoOncology-Biomarkers New AAM CEO Looking To ‘Force Multiply’ For US Generics Industry: https://pink.citeline.com/PS155294/New-AAM-CEO-Looking-To-Force-Multiply-For-US-Generics-Industry

Challenges in the Development and Manufacturing of ADCs

Tue, 24 Sep 2024 14:29:14 -0000

In this podcast, Andrew Warmington, Manufacturing Editor, Citeline, joins together with industry experts, Simone Secchi, R&D Process Chemist, Olon Group, and Matthieu Culie, Head of Development and GMP Manufacturing, GTP Bioways, Olon Group, to discuss the challenges in the development and manufacturing of ADCs.

September 2024 Datamonitor Healthcare Podcast: Radiopharmaceutical Usage is Heating Up

Thu, 19 Sep 2024 20:24:46 -0000

Emma Wille chats with oncology team director Dana Gheorghe, PhD, about the resurgence of radiopharmaceutical therapies in oncology. Other platforms (in addition to SoundCloud): Apple Podcasts -   https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836 Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU1NDkyOC9zb3VuZHMucnNz TuneIn - https://tunein.com/podcasts/Business--Economics-Podcasts/Pharma-Intelligence-Podcasts-p1140128/

Health-Related Quality of Life Considerations In Clinical Trials

Mon, 16 Sep 2024 00:00:00 -0000

In this podcast, Janelle Hart, Managing Editor at Citeline, teams up with industry experts Mai Yee Mishir, Senior Director of Global Regulatory Affairs, and Sally-Ann McDowell, Senior Director of Clinical Development Strategy at Advanced Clinical, to discuss the vital role of HRQoL in clinical trials. Listen now.

Over the Counter: Data Tech CEO On Digital Tools Driving Faster, More Sustainable Personal Care

Fri, 13 Sep 2024 23:02:30 -0000

In this episode, HBW chats with Neil D’Souza, CEO of Makersite GmbH, a Stuttgart, Germany-based data software company that offers product data management tools that enable personal care firms to manage product sustainability, cost and compliance. D’Souza provides his take on what defines sustainable product development and how companies can use technologies such as “digital twin” product models to analyze and improve sustainability, while developing products at a faster pace.

Drug Fix: US FDA Worries About Celebs Endorsing Drugs, Post-Chevron Lawsuits Emerging

Fri, 13 Sep 2024 16:38:29 -0000

Introduction: Pink Sheet reporter and editor discuss the FDA’s latest advertising enforcement letter, which targeted a migraine treatment TV commercial featuring Serena Williams, and its impact on drug promotion (:36), as well as the now growing list of legal cases targeting agency decisions with Chevron deference overturned (13:32). More On These Topics From The Pink Sheet Celebs Bring Extra Scrutiny To Advertisements, US FDA Tells AbbVie: https://pink.citeline.com/PS155225/Celebs-Bring-Extra-Scrutiny-To-Advertisements-US-FDA-Tells-AbbVie Lilly Challenges US FDA Classification Of Obesity Drug Retatrutide, Citing Chevron Overturn: https://pink.citeline.com/PS155205/Lilly-Challenges-US-FDA-Classification-Of-Obesity-Drug-Retatrutide-Citing-Chevron-Overturn Life After Chevron: US Supreme Court Ruling Cited In FDA Exclusivity Decision Challenges: https://pink.citeline.com/PS155211/Life-After-Chevron-US-Supreme-Court-Ruling-Cited-In-FDA-Exclusivity-Decision-Challenges US FDA Biologics Designation As Price Protection: Lilly Charts New Course With Retatrutide: https://pink.citeline.com/PS155226/US-FDA-Biologics-Designation-As-Price-Protection-Lilly-Charts-New-Course-With-Retatrutide

September 2024 Datamonitor Healthcare Podcast: Diving into the TME

Fri, 13 Sep 2024 11:28:19 -0000

Emma and Summer meet with oncology analyst Flora to discuss the therapeutic potential of exploring the tumor microenvironment. Apple Podcasts -   https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836 Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU1NDkyOC9zb3VuZHMucnNz TuneIn - https://tunein.com/podcasts/Business--Economics-Podcasts/Pharma-Intelligence-Podcasts-p1140128/ Spotify Podcasts - https://open.spotify.com/show/3DTc3eIh4xI6pVOd6DdO67

The Generics Bulletin Podcast: Recent And Upcoming Industry Events

Thu, 12 Sep 2024 14:22:22 -0000

Generics Bulletin's editorial team discusses recent conferences held by Medicines for Europe and the AAM, while looking ahead to the key off-patent industry events on the calendar over the next few months and beyond.

【3分で解説世界のファーマ】第21回中国企業日本で続々治験開始へ (Japanese-language podcast)

Tue, 10 Sep 2024 01:30:43 -0000

世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。今回取り上げた記事はこちら「Multiple Chinese Firms Expand Global Phase III Trials To Japan（邦訳：中国企業、第三相グローバル治験の地域を続々と日本に拡大）」 https://scrip.citeline.com/SC150842/Multiple-Chinese-Firms-Expand-Global-Phase-III-Trials-To-Japan Playlist: https://soundcloud.com/citelinesounds/sets/japanese-language-mini

J&J, '차별화된' 비만 자산에 관심있어 (Korean-language podcast)

Mon, 09 Sep 2024 23:37:55 -0000

호아킨 두아토 존슨앤존슨 대표가 모건스탠리 헬스케어 컨퍼런스에서 발표한 내용입니다. https://scrip.citeline.com/SC150846/JJ-Interested-In-Differentiated-Obesity-Assets Playlist: https://soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini

Scrip's Five Must-Know Things - 9 September 2024

Mon, 09 Sep 2024 02:47:10 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 6 September 2024. In this episode: J&J interested in differentiated obesity assets; Kerendia hits in heart failure; strong HERCULES data keep Sanofi’s MS plans alive; WCLC preview; and Mankind sets eyes on 5x growth. https://scrip.citeline.com/SC150865/Quick-Listen-Scrips-Five-MustKnow-Things Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Drug Fix: Pediatric Rare Disease PRV Deadline Approaches, Potential Makena Compounding Ban

Fri, 06 Sep 2024 16:46:37 -0000

Pink Sheet reporter and editors discuss the potential fallout if the US FDA’s rare pediatric disease priority review voucher program is allowed to sunset on 1 October (:30), as well as an upcoming agency advisory committee meeting on potentially banning compounding of the now withdrawn pre-term birth prevention drug Makena (18:39). More On These Topics From The Pink Sheet US FDA’s Rare Pediatric Voucher Program Faces Tight Deadline For Reauthorization: https://pink.citeline.com/PS155196/US-FDAs-Rare-Pediatric-Voucher-Program-Faces-Tight-Deadline-For-Reauthorization Ipsen Outpaces Market With Lucrative Priority Review Voucher Deal: https://pink.citeline.com/PS155197/Ipsen-Outpaces-Market-With-Lucrative-Priority-Review-Voucher-Deal

Scrip's Five Must-Know Things - 2 September 2024

Mon, 02 Sep 2024 02:06:09 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 30 August 2024. In this episode: summer ADC dealmaking continues apace; a look at cell therapies in Japan; Pfizer’s new US digital consumer platform; Galapagos’s US point of care CAR-T study; and Novartis partners with Lindy on biologics delivery. https://scrip.citeline.com/SC150827/Quick-Listen-Scrips-Five-MustKnow-Things Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Drug Fix: New US FDA Developments In AI Regulation

Fri, 30 Aug 2024 16:20:13 -0000

Pink Sheet reporter and editors discuss new developments in the FDA’s plans to regulate artificial intelligence and drugs associated with it, including a new AI Council within CDER, as well as some of the unanswered questions about AI in drug development. More On These Topics From The Pink Sheet Artificial Intelligence: CDER’s New Council Takes Charge Of Oversight, Coordination: https://pink.citeline.com/PS155173/Artificial-Intelligence-CDERs-New-Council-Takes-Charge-Of-Oversight-Coordination AI In Drug Development: Regulatory Clarity Needed On Inspections, Human Role: https://pink.citeline.com/PS155156/AI-In-Drug-Development-Regulatory-Clarity-Needed-On-Inspections-Human-Role

Digital Health Roundup: Digital Therapeutics Navigate GLP-1, Gaming; DHCoE On AI; Hello Heart

Thu, 29 Aug 2024 22:15:41 -0000

In this week’s Digital Health Roundup, Medtech Insight’s Ryan Nelson highlights Click Therapeutics’ FDA-cleared digital therapeutics (DTx) for depression and Sinaptica Therapeutics’ personalized neuromodulation for Alzheimer’s patients. Marion Webb discusses her interview with MindMaze’s John Krakauer on their gaming-focused DTx to help people recover from serious brain injuries. Elizabeth Orr introduces new voting members of the new Digital Health Advisory Committee and Natasha Barrow discusses Hello Heart’s new symptom-tracking feature in their heart-focused app. Stories discussed in this episode: MindMaze, ‘A Ratio Of Luke Skywalker And R2-D2’, Navigates The DTx Galaxy Click Therapeutics Anticipates Pharma Will Begin Developing Digital Drugs From Clinical Stage Sinaptica On Precision Neuromodulation To Combat Alzheimer’s: ‘No Drug Dares Go After Moderate Patients’ DHCoE-AI-Lifecycle-Management-Plan-To-Serve-As-Playbook-For-Standards Hello Heart Says Update To Cardiovascular Health Tracker Could Benefit Women Especially

Exploring The Postbiotic Opportunity In Consumer Health, With Kerry’s Sonja Nodland

Tue, 27 Aug 2024 06:47:25 -0000

Interest in the human gut microbiome and the influence it exerts on a person’s wellbeing, from cognitive health to immunity, has been rapidly increasing in recent years. In this episode of HBW Insight's Over the Counter podcast we speak to Dublin-based food company Kerry Group about a particularly exciting, emerging area of microbiome-based wellness, postbiotics, which are defined by the International Scientific Association of Probiotics and Prebiotics (ISAPP) as a “preparation of inanimate microorganisms and/or their components that confers a health benefit on the host.” Given that postbiotics rely on inanimate ingredients, rather than live cultures as in yoghurts, they, may provide more suitable vehicles for consumer health innovation, suggests Kerry Group’s RDA senior manager of immune and joint health, Sonja Nodland. Nodland also explains what kinds of postbiotics are currently on the European market, for example for digestive and skin health and immunity, and the regulatory challenges that postbiotics share with other microbiome products in the region, such as pre- and pro-biotics. Timestamps: 2:20 Introductions 4:00 What are postbiotics? 8:30 Advantages of postbiotics for consumer health innovation 10:20 Health benefits of postbiotics 12:00 Types of postbiotics 15:20 Kerry’s postbiotic portfolio 19:00 Postbiotic regulation in the European Union 28:00 Where to start with postbiotic innovation

Scrip's Five Must-Know Things - 26 August 2024

Mon, 26 Aug 2024 03:26:27 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 23 August 2024. In this episode: CMS’s price reveal better than expected?; new diabetes risk data for Zepbound; can J&J’s lung cancer combo stand up to Tagrisso?; new recruits for BioMarin leadership; and Glenmark’s shifting revenues. https://scrip.citeline.com/SC150795/Quick-Listen-Scrips-Five-MustKnow-Things Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

August 2024 Datamonitor Healthcare Podcast: The Colorful Landscape of Therapeutic Psychedelics

Thu, 22 Aug 2024 16:51:33 -0000

Following the recent FDA rejection of MDMA therapy for PTSD, Emma and Flora discuss the future role of psychedelics in the treatment of mental health disorders. Content warning: This episode does contain mentions of sexual assault and abuse. Apple Podcasts - https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836 Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU1NDkyOC9zb3VuZHMucnNz TuneIn - https://tunein.com/podcasts/Business--Economics-Podcasts/Pharma-Intelligence-Podcasts-p1140128/ Spotify Podcasts - https://open.spotify.com/show/3DTc3eIh4xI6pVOd6DdO67

Bioprinting – An Innovative Tool That Is Revolutionizing Drug Discovery

Mon, 19 Aug 2024 19:38:40 -0000

Keith Murphy, co-founder of Organovo, discusses the growing potential of bioprinting and how the company is using its technologies to study and develop treatments for inflammatory bowel disease (IBD).

Scrip's Five Must-Know Things - 19 August 2024

Mon, 19 Aug 2024 02:12:23 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 16 August 2024. In this episode: Merck & Co. steps into CD19 bispecific space; gene therapy patients rise, but slowly; Madrigal’s Rezdiffra plans; Korean biopharma financing recovering?; and approvals to watch out for in Q3. https://scrip.citeline.com/SC150765/Quick-Listen-Scrips-Five-MustKnow-Things Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Drug Fix: What We Learned From The First Batch Of Medicare Negotiated Drug Prices

Fri, 16 Aug 2024 18:15:14 -0000

Pink Sheet reporter and editors discuss the take-aways from the landmark first Medicare negotiated drug prices and what additional information remains outstanding. More On These Topics From The Pink Sheet Medicare Negotiation Announcement: Discounts From List Price Up To 79%, But Net Savings Unclear: https://pink.citeline.com/PS155128/Medicare-Negotiation-Announcement-Discounts-From-List-Price-Up-To-79-But-Net-Savings-Unclear Medicare Unveils Negotiated Prices, But Near-Term Opportunity To Learn From Process Is Limited: https://pink.citeline.com/PS155129/Medicare-Unveils-Negotiated-Prices-But-NearTerm-Opportunity-To-Learn-From-Process-Is-Limited Round 1 Of US Drug Price Negotiations Suggests Medicare Can Beat Original Part D System: https://pink.citeline.com/PS155130/Round-1-Of-US-Drug-Price-Negotiations-Suggests-Medicare-Can-Beat-Original-Part-D-System The Next 340B Battle: Discount Duplication With Medicare Negotiated Prices: https://pink.citeline.com/PS155043/The-Next-340B-Battle-Discount-Duplication-With-Medicare-Negotiated-Prices

【3分で解説世界のファーマ】第20回欧州心臓病学会注目の新薬候補は (Japanese-language podcast)

Thu, 15 Aug 2024 02:55:02 -0000

世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。今回取り上げた記事はこちら What To Look Out For At ESC 2024 https://scrip.citeline.com/SC150740/What-To-Look-Out-For-At-ESC-2024

Sustainable By Design: Thermo Fisher's Meron Mathias On ESG Compliance And The Competitive Edge

Wed, 14 Aug 2024 11:26:32 -0000

Compliance with environmental sustainability goals is no longer optional for medtech companies serving global healthcare markets. Thermo Fisher has made it a mission to be a leader in thought and actions in meeting Scope 1, 2 and 3 needs. Corporate VP and head of sustainability Meron Mathias explains the company's sustainability aims and methods, for itself and its customers, and stresses the importance of continuing to enhance patient care with innovative products at the same time.

Scrip's Five Must-Know Things - 13 August 2024

Tue, 13 Aug 2024 02:34:49 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 9 August 2024. In this episode: Amgen positions for obesity and diabetes; BMS returns TIGIT asset in pipeline reshuffle; is Kerendia the next jewel in Bayer’s crown?; Japan pharma firms cut jobs; and Sun Pharma seeks GLP-1 partner. https://scrip.citeline.com/SC150739/Quick-Listen-Scrips-Five-MustKnow-Things Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Why Purpose Is Key To Driving CHC Growth, With Haleon’s Bas Vorsteveld

Mon, 12 Aug 2024 07:07:20 -0000

Since becoming a standalone consumer health company, Haleon has been driving awareness of public health issues such as chronic pain and children’s oral health. In this episode of Over the Counter, HBW Insight catches up with Haleon vice president and general manager Great Britain and Ireland Bas Vorsteveld, to find out more about why having a purpose is so important to establishing and growing a consumer health brand, looking in particular at the firm’s recent Aquafresh campaign, which saw it team up with British photographer, Rankin, to capture powerful portraits of children’s growing teeth to encourage them to be more confident. We also talk about Haleon’s ambitious climate commitments, and why ambition is important, alongside transparency about the challenges that such ambition brings. 2:00 – Introductions 2:50 – Aquafresh x Rankin 8:00 – The Importance of Having a Purpose 12:15 – Advantages of Being a Standalone 15:30 – Sustainability as Purpose 19:20 – Leading by Example 23:20 – Aiming High 25:20 – Being Transparent’ 26:50 – Haleon’s Two-Year Anniversary 30:00 – VMS Growth and Preventative Health 32:20 – Pain Against the Grain 37:00 – The Year Ahead

Drug Fix: Clinical Trial Diversity, Off-Label Standard Of Care Issues, In-Person US FDA Adcomms

Fri, 09 Aug 2024 16:23:35 -0000

Pink Sheet reporter and editors discuss former Surgeon General Jerome Adams’ views on how the FDA can better ensure clinical trial diversity (:27), questions about approving a new drug that would be used with a standard of care regimen that is off-label (15:00), and the agency beginning to schedule fully in-person advisory committee meetings (24:03). More On These Topics From The Pink Sheet ‘You Shall Not Pass:' Former Surgeon General On Why US Government Should Push Trial Diversity: https://pink.citeline.com/PS155063/You-Shall-Not-Pass-Former-Surgeon-General-On-Why-US-Government-Should-Push-Trial-Diversity Gaps Found In Most Pharma Trial Diversity Policies: https://pink.citeline.com/PS155086/Gaps-Found-In-Most-Pharma-Trial-Diversity-Policies Zevra’s Arimoclomol Use With Standard Of Care Complicates US FDA Adcomm Efficacy Assessment: https://pink.citeline.com/PS155091/Zevras-Arimoclomol-Use-With-Standard-Of-Care-Complicates-US-FDA-Adcomm-Efficacy-Assessment Back To White Oak: US FDA Adcomms Go Fully In-Person, Starting With Antimicrobials Panel: https://pink.citeline.com/PS155100/Back-To-White-Oak-US-FDA-Adcomms-Go-Fully-InPerson-Starting-With-Antimicrobials-Panel

Type 2 Diabetes and SGLT2 Inhibitors Q&A

Fri, 09 Aug 2024 13:26:27 -0000

In this audio, Dr. Anthony Fritz discusses Type 2 diabetes and the benefits of SGLT2 inhibitors. Learn how this treatment option can improve diabetes care.

비만치료제, 2024년 상반기 대형주를 지배하다 (Korean-language podcast)

Wed, 07 Aug 2024 00:00:29 -0000

올해 상반기 일라이 릴리와 노보 노디스크의 주가가 가장 높은 상승세를 보인 반면, BMS와 길리어드의 주가는 가장 큰 폭으로 하락했습니다. Scrip의 글로벌 제약주 동향 기사를 요약한 내용입니다. https://scrip.citeline.com/SC150593/Obesity-Rules-Large-Cap-Stocks-In-First-Half-Of-2024

Scrip's Five Must-Know Things - 5 August 2024

Mon, 05 Aug 2024 02:49:58 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 2 August 2024. In this episode: Pfizer bullish on its oral GLP-1; BMS’s rising confidence about Medicare pricing of Eliquis; more long term data for Leqembi; NewAmsterdam’s CETP inhibitor shows promise; and a look at Mankind’s Bharat Serums buy. https://scrip.citeline.com/SC150698/Quick-Listen-Scrips-Five-MustKnow-Things Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Drug Fix: August User Fee Goals, Oncology Trial Design Issues, EMA Review Changes

Fri, 02 Aug 2024 17:07:54 -0000

Pink Sheet reporter and editors discuss the US FDA drug approval decisions that could arrive in August (:34), a trial design issue that could ensnare BMS’ Opdivo along with AstraZeneca’s Imfinzi (10:11), and the EMA potentially asking all sponsors to provide raw clinical data as part of application reviews (33:14). More On These Topics From The Pink Sheet Dozen Novel Agents Dream Of August US FDA Approval: https://pink.citeline.com/PS155070/Dozen-Novel-Agents-Dream-Of-August-US-FDA-Approval BMS’s Opdivo May Be Next Casualty Of US FDA’s Perioperative Trial Redesign Push: https://pink.citeline.com/PS155056/BMSs-Opdivo-May-Be-Next-Casualty-Of-US-FDAs-Perioperative-Trial-Redesign-Push EU Pilot On Raw Data Analysis Shows Benefits For Streamlining Medicines Evaluation: https://pink.citeline.com/PS155059/EU-Pilot-On-Raw-Data-Analysis-Shows-Benefits-For-Streamlining-Medicines-Evaluation

China Biotech Podcast - 2 August 2024 (Chinese language)

Fri, 02 Aug 2024 05:56:38 -0000

RNK Pharma founder and CEO Yaning Wang joins Brian Yang to discuss Shanghai's latest biopharma stimulus policies and the globalization of China biotech. Dexter Yan also discusses China biotech initial public offerings in the first half of this year.

July 2024 Datamonitor Healthcare Podcast: The Future of Biologics in COPD

Wed, 31 Jul 2024 06:48:40 -0000

COPD expert Wen-Yu discusses what the entrance of biologics might mean for the COPD treatment landscape and shares a sneak peek from her upcoming patient-based forecast. Other platforms (in addition to SoundCloud): Apple Podcasts -   https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836 Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU1NDkyOC9zb3VuZHMucnNz TuneIn - https://tunein.com/podcasts/Business--Economics-Podcasts/Pharma-Intelligence-Podcasts-p1140128/ Spotify Podcasts - https://open.spotify.com/show/3DTc3eIh4xI6pVOd6DdO67

Q&A Session on the Treatment of Multiple Myeloma

Mon, 29 Jul 2024 18:47:51 -0000

Join us for an insightful Q&A session on the treatment of multiple myeloma with Oncologist Dr. Joshua Richter. In this video, Dr. Richter shares his expert knowledge on the latest advancements, treatment options, and patient care strategies for multiple myeloma.

How To Make An Impact With Your OTC Brand, With PA Consulting’s Rhea Patten

Mon, 29 Jul 2024 07:08:56 -0000

Consumers are expecting more and more from health and wellness brands, PA Consulting’s latest Brand Impact Index shows. Consumer health brands that link wellness to the sanctuary of the home do particularly well, explains PA consumer product expert Rhea Patten, on the latest episode of HBW Insight’s Over the Counter podcast. But do consumers expect too much? Do consumer heath companies really have a responsibility to help save the world? Patten says yes, and stresses that doing so will ultimately provide greater opportunities for brand impact and ultimately business growth.

Scrip's Five Must-Know Things - 29 July 2024

Mon, 29 Jul 2024 02:41:52 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 26 July 2024. In this episode: Narasimhan plays the long game; Merck & Co’s RSV contender; Mounjaro’s China approval; the mid-cap rising stars; and AI could add billions in drug revenues. https://scrip.citeline.com/SC150656/Quick-Listen-Scrips-Five-MustKnow-Things Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Drug Fix: US FDA Device Director Retires, PBM Execs On Capitol Hill, Voucher Program Renewal Push

Fri, 26 Jul 2024 20:57:39 -0000

Editors from the Pink Sheet and Medtech Insight discuss the retirement of Jeff Shuren (:35), PBM executives again appearing unscathed after another Capitol Hill appearance (10:12), and the growing push to ensure the FDA’s rare pediatric disease priority review voucher program is renewed (20:41). More On These Topics From The Pink Sheet Shuren Steps Down As US FDA Device Center Director: https://pink.citeline.com/PS155031/Shuren-Steps-Down-As-US-FDA-Device-Center-Director PBM Execs Stay On Message Amid Growing US Congressional Frustration At Hearing: https://pink.citeline.com/PS155030/PBM-Execs-Stay-On-Message-Amid-Growing-US-Congressional-Frustration-At-Hearing FDA Leadership Changes Tune On Pediatric Priority Review Voucher Benefit: https://pink.citeline.com/PS155019/FDA-Leadership-Changes-Tune-On-Pediatric-Priority-Review-Voucher-Benefit

The Exciting Future of Heart Failure Management

Fri, 26 Jul 2024 15:55:10 -0000

Join Victoria Bradley and Dr. Andrew Freeman as they discuss the latest advancements in heart failure treatment, from innovative therapies to the role of AI and personalized medicine. Discover how technology is revolutionizing patient care, ensuring patient safety, and improving outcomes.

Early Detection Key in COPD Management (Q&A with Brittany Little, NP)

Fri, 26 Jul 2024 14:18:07 -0000

This Q&A session emphasizes early diagnosis of COPD for better lung function preservation and disease control. It explores COPD symptoms, diagnosis tools, treatment options, and the importance of lifestyle changes, especially smoking cessation.

Digital Health Roundup: Brain Talk; Medtronic’s Digital Tech Report OR; UK Guidance

Tue, 23 Jul 2024 22:09:07 -0000

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights AI discussions at the HLTH Europe conference and an interview with Motif Neurotech's CEO Jacob Robinson. Elizabeth Orr discusses DeepWell DTx's newly launched VR game for treating stress-related hypertension and anxiety. Natasha Barrow provides an overview of Digital Mental Health Technologies regulation in the UK and Brian Bossetta reports ‘the good and bad’ from Medtronic's report on digital technologies' use in the operating room. Listen to the podcast via the player below: Medtech Insight articles addressing topics discussed in this episode: Zeto Wins FDA Clearance For Novel Seizure Detection Device Outdated Technology Keeping Surgeons From Operating At Their Best: Medtronic Report :: Medtech Insight DeepWell DTx Brings Mental Health To Meta Store Healthtech Leaders Discuss Impact (And Risks) Of Generative AI And AI In Health Care Is This Doomsday Concern, Or Is It Reality? Verily CMO On AI’s Future, Lightpath Metabolic, More News We’re Watching: UK Plans Digital Health Guidance, FDA Warns Against Getinge/Marquet Cardiac Devices

Scrip's Five Must-Know Things - 22 July 2024

Mon, 22 Jul 2024 03:53:51 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 19 July 2024. In this episode: J&J’s Spravato on track for blockbuster status; US uptake of Rezzdifra held up by payers; CNS drugs are surprisingly valuable; obesity rules large cap stocks; and Legend buyout rumors validate China biotech. https://scrip.citeline.com/SC150621/Quick-Listen-Scrips-Five-MustKnow-Things Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Medtech Connect 16: AI For Cross Border Regulation

Sat, 20 Jul 2024 18:28:11 -0000

In this episode, Medtech Insight senior reporter Hannah Daniel speaks to DJ Fang, chief operating officer and co-founder of Pure Global. Pure Global uses AI to help device manufacturers navigate global regulations, and we talk about clinical trials, how countries incentivize medtech innovation, and the Biden Administration’s tariffs on some Chinese-made medical devices.

Drug Fix Special: Why The US Approves Most New Drugs Before The EU

Fri, 19 Jul 2024 15:28:35 -0000

Pink Sheet reporter and editors discuss the impact of a US and EU drug approvals analysis that found the US FDA still clears many novel products first, including most new cell and gene therapies and cancer treatments. More On This Topics From The Pink Sheet Pharma Looks To America First: US FDA Holds Overwhelming Lead Over EMA In Novel Approvals: https://pink.citeline.com/PS154948/Pharma-Looks-To-America-First-US-FDA-Holds-Overwhelming-Lead-Over-EMA-In-Novel-Approvals Getting To Global Is A Hurdle For Cell And Gene Therapies: https://pink.citeline.com/PS154953/Getting-To-Global-Is-A-Hurdle-For-Cell-And-Gene-Therapies New Oncologics Overwhelmingly Approved In US Before EU: https://pink.citeline.com/PS154952/New-Oncologics-Overwhelmingly-Approved-In-US-Before-EU Approval Geography: Novel Agent Landscape Across US And EU: https://pink.citeline.com/PS154950/Approval-Geography-Novel-Agent-Landscape-Across-US-And-EU US FDA Offers Faster Route To Market Than EMA: Details On All 108 Approvals: https://pink.citeline.com/PS154951/US-FDA-Offers-Faster-Route-To-Market-Than-EMA-Details-On-All-108-Approvals

국내 AI 신약개발, 선진국과 격차 줄이려면? (Korean-language podcast)

Tue, 16 Jul 2024 23:35:54 -0000

신테카바이오 조해경 사장은 Scrip과의 인터뷰에서 국내 AI 신약 개발 현황을 글로벌 흐름와 비교하고, 국내외 경쟁에서 살아남기 위해 국내업계가 해야 할 일에 대해 이야기했습니다. https://scrip.citeline.com/SC150336/Korea-Looks-To-Close-Gap-In-AI-Drug-Development-Capabilities

The Importance of Exploring Genetic Potential

Tue, 16 Jul 2024 13:39:02 -0000

Discover the key considerations critical to the genetic analysis for advanced therapies, including qPCR and dPCR. Don’t miss expert insights from Chandler Walker, Product Manager of Digital PCR Instruments at Thermo Fisher Scientific and Janelle Hart, managing editor at Citeline.

Scrip's Five Must-Know Things - 16 July 2024

Tue, 16 Jul 2024 02:45:35 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 12 July 2024. In this episode: Q1’s top 10 drugs; Pfizer’s R&D leadership succession; Lilly bolsters IBD pipeline; first half deal volume up but value down; and EU firms’ China sentiment plummets. https://scrip.citeline.com/SC150587/Quick-Listen-Scrips-Five-MustKnow-Things Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

EPR Consultant Urges Producers To Start Collecting Packaging Data

Fri, 12 Jul 2024 15:59:03 -0000

In this episode, HBW chats with Michael Washburn, principal at Washburn Consulting, on how producers of single-use packaging subject to extended producer responsibility laws rolling out in Oregon, Colorado and California next year can tackle the tedious work of collecting data on packaging materials.

Improving Communication: The Relationship Between Biotech And Biopharma

Wed, 10 Jul 2024 13:41:35 -0000

Improving Communication: The Relationship Between Biotech And Biopharma by Citeline

【3分で解説世界のファーマ】第19回 FDA「密な面談」を企業に呼び掛け (Japanese-language podcast)

Tue, 09 Jul 2024 04:49:35 -0000

世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。今回取り上げた記事はこちら「US FDA’s Cell-Gene Therapy Office Head Wants Sponsors To Seek Out Meetings（邦題意訳：米国FDAの細胞遺伝子治療室長「もっと面談を」企業に求める理由は）」（英語版） https://pink.citeline.com/PS154749/US-FDAs-Cell-Gene-Therapy-Office-Head-Wants-Sponsors-To-Seek-Out-Meetings ※全文の閲覧には購読（有料）が必要です。世界の製薬ビジネスメディアScrip（スクリップ）とは？ https://www.citeline.com/ja-jp/products-services/commercialization/scrip

Scrip's Five Must-Know Things - 8 July 2024

Mon, 08 Jul 2024 02:52:14 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 5 July 2024. In this episode: US approval for Lilly’s Alzheimer's contender; the challenges and rewards of late-stage ADCs; Eisai regains control of ADC from BMS; RSV vaccine developers hit by declining expectations; and an interview with Amgen’s Ian Thompson. https://scrip.citeline.com/SC150550/Quick-Listen-Scrips-Five-MustKnow-Things Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Scrip M&A Podcast: A Midyear Review of Biopharma Dealmaking and Expectations of What's Ahead

Fri, 05 Jul 2024 19:15:14 -0000

Scrip's Joseph Haas, Mandy Jackson and Kevin Grogan discuss the biopharma dealmaking environment as we reach the midpoint of 2024. Haas reviews dealmaking data from the first six months of the year and discusses what experts expect in the months ahead. Jackson and Grogan talk about the industry mood coming out of the annual BIO conference in June and what they heard at the meeting.

Non-Invasive Solutions: Exploring The Role Of Breath Biopsies In Early Detection

Fri, 05 Jul 2024 10:48:44 -0000

In this episode of the In Vivo podcast, Billy Boyle, CEO of Owlstone Medical, discusses how his company is developing several breath biopsy products for use by clinicians, biopharma companies and researchers.

In Vivo Podcast Episode with Stefan Woxström

Tue, 02 Jul 2024 11:27:13 -0000

In Vivo Podcast Episode with Stefan Woxström by Citeline

How To Innovate For The Ages, With Bayer’s Reese Fitzpatrick And Rachel Koontz

Mon, 01 Jul 2024 07:13:04 -0000

Aspirin is celebrating its 125th anniversary this year. To find out what brand owner Bayer Consumer Health is doing to celebrate this occasion, and what it is doing to take the brand into the next 125 years, HBW Insight chats with the company’s senior vice president, Global Head Allergy, Cough/Cold, Pain and Heart Health, Reese Fitzpatrick, and head of R&D, North America and Therapeutics, Rachel Koontz. Already used for a variety conditions by consumers and patients across the world, the Aspirin brand has much more to offer, they argue, for example, in terms of digital self-care, with the firm working with British medtech firm Huma Therapeutics on a Heart Health Risk Assessment app that it currently markets in the US and Middle East. Aspirin also still has Rx-to-OTC switch potential, they reveal, for example in markets like Mexico where the brand is not already available without a prescription. And if that’s not enough, we also discuss Bayer’s extension of the Aspi brand into the naturals space, particularly in the cough and cold category in Europe. Timestamps 2:25 – Introductions 3:30 – Aspirin’s 125th anniversary 5:50 – Aspirin’s brand longevity 14:15 – Challenges of self-care 25:20 – Digital self-care and chronic conditions 27:50 – Aspirin’s Rx-to-OTC switch potential 33:30 – Science and self-care 39:90 – Natural alternatives 44:15 – What’s next for Aspirin?

Scrip's Five Must-Know Things - 1 July 2024

Mon, 01 Jul 2024 03:08:50 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 28 June 2024. In this episode: global CEO remuneration; another late-stage loss for Merck KgaA; deals shift to smaller M&A, partnering; Bayer’s Parkinson’s bets bear fruit; and India looks to innovate CAR-T models. https://scrip.citeline.com/SC150517/Quick-Listen-Scrips-Five-MustKnow-Things Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Drug Fix: What’s In And Out Of US FDA’s Diversity Action Plan Guidance, AI Guidance Also Coming

Fri, 28 Jun 2024 19:15:38 -0000

Pink Sheet reporter and editors discuss what the FDA included in its long-awaited guidance on clinical trial diversity action plans, along with what was left out (:35), as well as an upcoming guidance on the use of artificial intelligence in regulatory decision-making (27:30). More On These Topics From The Pink Sheet Diversity Action Plans Should Be Brief And Waiver Requests Filed Early, US FDA Says: https://pink.citeline.com/PS154894/Diversity-Action-Plans-Should-Be-Brief-And-Waiver-Requests-Filed-Early-US-FDA-Says Diversity Enrichment: US FDA Guidance Suggests Sponsors May Need To Overenroll Key Groups: https://pink.citeline.com/PS154895/Diversity-Enrichment-US-FDA-Guidance-Suggests-Sponsors-May-Need-To-Overenroll-Key-Groups US FDA Guidance On Artificial Intelligence For Regulatory Decision-Making Expected This Year: https://pink.citeline.com/PS154868/US-FDA-Guidance-On-Artificial-Intelligence-For-Regulatory-Decision-Making-Expected-This-Year

China Biotech Podcast - 26 June 2024 (Chinese language)

Wed, 26 Jun 2024 05:01:31 -0000

Guest speaker “Angus” Shipo Xie of Hankun Law joins Brian Yang to discuss new overseas data transfer rules, while Dexter Yan explains China biotechs' Hutchmed, Jiangsu Hengrui and Innovbent Bio’s clinical data readouts at the recent EHA and ADA annual meetings. https://scrip.citeline.com/SC150487/China-Biotech-Podcast-EHAADA Playlist: https://soundcloud.com/citelinesounds/sets/chinese-language-biopharma

Scrip's Five Must-Know Things - 24 June 2024

Mon, 24 Jun 2024 03:30:31 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 21 June 2024. In this episode: the outlook for 2025 launches; Merck confident in new pneumococcal vaccine; multiple US setbacks for Japanese firms; Stock Watch on Moderna missteps; and Sun’s North America head talks plans and strategy. https://scrip.citeline.com/SC150476/Quick-Listen-Scrips-Five-MustKnow-Things Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Lung Life AI CEO Shares Regulatory And Reimbursement Journey For Lung Cancer Diagnostic, Lung LB

Fri, 21 Jun 2024 12:00:57 -0000

In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI’s journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement and compliance with the US FDA Lab Developed Test ruling.

The Power Of Herbs For Women’s Wellness, With The SABI’s Hilary Metcalfe and Anna Cave-Bigley

Mon, 17 Jun 2024 08:15:21 -0000

In this episode, HBW Insight chats with women’s health start-up The SABI about the power of herbal medicine for hormonal wellness. “Inspired by a series of painfully honest conversations they had about their hormonal and emotional challenges,” The SABI markets a range of herbal infusions aimed at alleviating some of the impacts of painful periods and hormonal imbalances, such as digestive discomfort, sleep disruption and anxiety. The SABI founders Hilary Metcalfe and Anna Cave-Bigley also reveal the difficulties of being a woman-led, women’s health startup in a male dominated world, especially when it comes to funding and research. We also discuss the importance of getting the message right, both in terms of connecting women to their hormonal health but also distinguishing The SABI from less credible women’s wellness brands. Timestamps: 2:00 Introductions 5:00 The power of herbs 11:45 The challenges of being a women’s health startup 17:30 The demand for natural women’s health products 24:50 Controversies surrounding natural women’s health alternatives 32:45 What’s next for The SABI Biographies Anna Cave-Bigley is CEO at The SABI, leading sales and strategy “with her signature drive and keen insight on everything from motherhood, hormone balance and mental health to strategy, sales and global operations.” From being a founding member of the international practice for a leading London communication consultancy to spearheading international investment initiatives for the British Government, Anna has honed her operational business expertise over 13 years. She is mother to Lorenzo and Alfie, who “inspired her to co-found The SABI after her devastating experience with clinical postpartum depression.” Co-founder Hilary Metcalfe is a Harvard graduate and accomplished business strategist, who dedicated 12 years to impact investment, sustainability, and management consulting before her health intervened. “Conventional medicine offered only a lifetime of medication for chronic migraines and my then-undiagnosed endometriosis. Determined to find a more natural approach, I became a certified holistic nutritionist, product developer and chef, building and selling a successful plant-based food startup in Amsterdam.” During this time Hilary began formulating the remedies and products that would become The SABI’s core collection.

Scrip's Five Must-Know Things - 17 June 2024

Mon, 17 Jun 2024 02:45:21 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 14 June 2024. In this episode: Boehringer best in MASH?; biopharma funding on an upswing?; Moderna’s combo jab; clinical trial recover from pandemic; and Astellas’s US commercial head speaks. https://scrip.citeline.com/SC150442/Quick-Listen-Scrips-Five-MustKnow-Things Playlist: https://soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Building And Scaling Your Workforce: The Importance Of A Flexible Delivery Model In 2024 & Beyond

Fri, 14 Jun 2024 21:12:00 -0000

In this podcast, Janelle Hart, Managing Editor, Citeline, joins industry experts Jessica Wall, Director of Talent Acquisition, and Morgan Seaman, Associate Director of FSS Operations, both from Advanced Clinical, to discuss the latest trends and challenges in building, scaling and differentiating workforces in the life sciences sector. Talent acquisition is central to fostering creativity and innovation within any organization. In today’s highly competitive and fast-moving life sciences sector, it’s more important than ever. Tune into this free podcast to gain valuable insights on maintaining a competitive edge through innovative recruitment and retention strategies. Listen now to explore more!

June 2024 Datamonitor Healthcare Podcast: ASCO 2024

Fri, 14 Jun 2024 13:52:16 -0000

The oncology team from Datamonitor Healthcare and healthcare journalist, Alaric, provide broad analytical coverage of key highlights from the ASCO 2024 conference. Apple Podcasts -   https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836 Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU1NDkyOC9zb3VuZHMucnNz TuneIn - https://tunein.com/podcasts/Business--Economics-Podcasts/Pharma-Intelligence-Podcasts-p1140128/ Spotify Podcasts - https://open.spotify.com/show/3DTc3eIh4xI6pVOd6DdO67

China Biotech Podcast - 14 June 2024 (Bilingual Chinese/English)

Fri, 14 Jun 2024 05:30:56 -0000

Guest speaker, US-based Pink Sheet senior writer Sarah Karlin-Smith, joins Brian Yang and Dexter Yan in China to discuss the recent BIO Conference, updates to the planned US BIOSECURE Act and industry preparations for its impact. Dexter also discusses China biotech's data highlights from ASCO 2024. https://scrip.citeline.com/SC150438/China-Biotech-Podcast-BIOSECURE-Act-Updates--ASCO-Highlights Playlist: https://soundcloud.com/citelinesounds/sets/chinese-language-biopharma

ASCO 결산: 암 연구의 미래는? (Korean-language podcast)

Thu, 13 Jun 2024 00:52:25 -0000

글로벌 제약업계는 암 연구의 미래를 어떻게 보고 있을까? Scrip의 ASCO 현장 취재 기사를 요약한 내용입니다. https://scrip.citeline.com/SC150378/ASCO-Roundup-Looking-For-The-Future-Of-Cancer-Research Playlist: https://soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini

Scrip's Five Must-Know Things - 10 June 2024

Mon, 10 Jun 2024 02:49:15 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 7 June 2024. In this episode: BIO Notebook; ASCO roundup; data on Carvykti in community at ASCO; strong new results for tirzepatide in MASH; and orphan slowdown signals new path ahead. https://scrip.citeline.com/SC150401/Quick-Listen-Scrips-Five-MustKnow-Things Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

The Generics Bulletin Podcast: Teva, Sandoz, Sawai and US Orange Book patents

Fri, 07 Jun 2024 14:02:24 -0000

Generics Bulletin's editorial team discusses the latest strategic developments for major industry players Teva, Sandoz and Sawai, as well as explaining the recent debate over US patent listings in the FDA's Orange Book.

China Biotech Podcast - 5 June 2024 (Chinese language)

Wed, 05 Jun 2024 00:44:33 -0000

Guest speaker Guangzuo Luo, chief scientific officer of Bioncetech, joins China-based editors Brian Yang and Dexter Yan in this episode, which looks at Chinese biotechs going global, and the opportunities and challenges in the latest industry latest trends. https://scrip.citeline.com/SC150370/China-Biotech-Podcast-Going-Global-Trends-Rare-Disease-Drug-Development Playlist: https://soundcloud.com/citelinesounds/sets/chinese-language-biopharma?si=80b1209c44874afa9c44bf7d30538320&utm_source=clipboard&utm_medium=text&utm_campaign=social_sharing

JB CEO On CDMO Growth, Red Sea Crisis And More

Tue, 04 Jun 2024 00:52:15 -0000

In an interview with Scrip, JB CEO Nikhil Chopra addresses rumours of a sale of a stake in the Indian pharma/CDMO company by private equity fund KKR, recent acquisitions, including from Novartis, as well as JB's ambitions to ramp up the cardiology segment and its CDMO business, which already has major clients including J&J. https://scrip.citeline.com/SC150350/Amid-Talk-Of-KKR-Stake-Sale-JB-CEO-Stresses-Business-As-Usual

Scrip's Five Must-Know Things - 3 June 2024

Mon, 03 Jun 2024 05:04:16 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 31 May 2024. In this episode: ASCO preview; Asahi’s US acquisition; Novartis aims for renal disease dominance; paying for gene therapies; and US BIOSECURE Act diluted. https://scrip.citeline.com/SC150361/Quick-Listen-Scrips-Five-MustKnow-Things Playlist: https://soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

The Scrip Awards Podcast. Episode 1: Genmab: The Ongoing Evolution Of Europe’s Antibody Powerhouse

Fri, 31 May 2024 15:37:53 -0000

An interview with Genmab’s Jan van de Winkel to mark 25 years of the company, and 20 years of the Scrip Awards. A brief history of the antibody-focused biotech company so far, and its plans for future expansion.

How Corporate Sustainability Reporting ‘Just Got Serious,’ With CEN-ESG’s Jasper Crone

Fri, 31 May 2024 15:13:12 -0000

In this episode we unpack the Corporate Sustainability Reporting Directive (CSRD) with the help of ESG expert Jasper Crone, drilling down into exactly what consumer healthcare companies need to know about this enormously complex and significant piece of EU legislation. 3:30 Introduction to the CSRD 7:45 What companies are affected by the CSRD 15:00 Specific implications for consumer health companies 21:00 Getting materiality right 25:00 CSRD to do list 32:00 Who’s afraid of targets? 37:00 Who’s responsible for CSRD in companies? 39:00 CSRD and the EU Green Deal 45:00 How will CSRD shape the way companies operate?

Navigating IND Applications & Pre-IND Meetings: Key Considerations And Misconceptions

Fri, 31 May 2024 06:38:47 -0000

Advancing Investigational New Drugs (INDs) can be a complex process, especially for smaller companies. Listen to your free podcast now as Marcus Delatte, PhD, Vice President at Allucent and Harshini Neelakantan, Executive Director at Ridgeline Therapeutics discuss best practices and considerations for leveraging your pre-IND meeting and submitting a successful IND application. Listen now for insights into: • Current trends and challenges related to IND submissions • The purpose and benefits of pre-IND meetings with regulatory bodies • Indicators that should prompt companies to request a pre-IND meeting • The role of consultants in supporting sponsors in pre-IND meetings • Getting the most from your pre-IND meeting and tips for IND application success • How IND submissions will evolve in the future

'CorpPharma Is Not Just A Cost Component’ – Showcasing Value As Well As Innovation

Wed, 29 May 2024 13:56:38 -0000

Astellas Pharma’s chief commercial officer, Claus Zieler, discusses the biopharma industry’s responsibility to drive change in health care.

China Biotech CEO Interview - NeuShen's Joan Huaqiong Shen

Tue, 28 May 2024 07:32:08 -0000

NeuShen CEO Joan Shen discusses with Brian Yang about developing CNS drugs in China, the venture's business rationale, challenges and fundraising. She also discusses two leading assets for schizophrenia and epilepsy in first-in-human studies, as well as a gene therapy collaboration for ALS with UMass's Gao Lab. https://scrip.citeline.com/SC150328/China-Biotech-CEO-Interview-Starting-A-CNS-Venture-In-An-Economic-Downturn Playlist: https://on.soundcloud.com/AaFyPUxfD2RiDEis5

Citeline Japan Awards 2024 - Enter Now! (Bilingual English/Japanese)

Tue, 28 May 2024 02:45:34 -0000

As the 15 July entry deadline for the 3rd edition of the annual Citeline Japan Awards approaches, join us in this bilingual English/Japanese podcast to learn more about the categories and event itself. (Japanese starts at 2' 25".) English event site: https://www.citeline.com/en/awards/citelinejapanawards Japanese event site: https://www.citeline.com/ja-jp/awards/citelinejapanawards

Scrip's Five Must-Know Things - 27 May 2024

Mon, 27 May 2024 06:31:25 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 24 May 2024. In this episode: Biogen’s immunology acquisition; AstraZeneca looks to cement respiratory lead; why US FTC is tough on pharma; the US election’s impact on pharma; and how new AI tools are impacting medical affairs. https://scrip.citeline.com/SC150324/Quick-Listen-Scrips-Five-MustKnow-Things Playlist: https://soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Drug Fix: Novel Clinical Trial Reg Problems, NIH Drug ‘Access Plans’, Good Ole Days Of Woodcock

Fri, 24 May 2024 16:08:18 -0000

Pink Sheet editors discuss the US FDA’s consideration of regulatory changes to promote innovative clinical trial designs (:32), an NIH proposal to require patent licensees create plans to ensure access to the commercialized product (7:29), and lawmakers longing for the days when Janet Woodcock ran the FDA’s Center for Drug Evaluation and Research (15:35). More On These Topics From The Pink Sheet ‘Antiquated’ Regulations Slowing Adoption of Innovative Clinical Trial Approaches: https://pink.citeline.com/PS154730/Antiquated-Regulations-Slowing-Adoption-of-Innovative-Clinical-Trial-Approaches US FDA Looking To Modernize Clinical Trial Regulations To Spur ‘Evolution’ In Research: https://pink.citeline.com/PS154721/US-FDA-Looking-To-Modernize-Clinical-Trial-Regulations-To-Spur-Evolution-In-Research NIH Drug Patent Licensees Would Develop ‘Access Plan’ Under Proposal; Pricing Commitments Optional: https://pink.citeline.com/PS154744/NIH-Drug-Patent-Licensees-Would-Develop-Access-Plan-Under-Proposal-Pricing-Commitments-Optional Woodcock Nostalgia: GOP Rep. Bilirakis Wants CDER To Recapture Her Flexible Approach: https://pink.citeline.com/PS154745/Woodcock-Nostalgia-GOP-Rep-Bilirakis-Wants-CDER-To-Recapture-Her-Flexible-Approach

【3分で解説世界のファーマ】第18回 GLP-1を超える肥満治療薬のカギとは？(Japanese-language podcast)

Thu, 23 May 2024 00:08:30 -0000

世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。今回取り上げた記事はこちら「Hibernating Squirrels And Exercise In A Pill: The Next Wave of Cardiometabolic Therapies（邦題意訳：GLP-1を超える心代謝系治療薬のヒントは、冬眠するリスか、地道な運動か）」（日本語版） https://www.citeline.com/ja-jp/resources/hibernating-squirrels-and-exercise-in-a-pill ※全文の閲覧には情報の登録（無料）が必要です。（英語版） https://scrip.citeline.com/SC150222/Hibernating-Squirrels-And-Exercise-In-A-Pill-The-Next-Wave-of-Cardiometabolic-Therapies 世界の製薬ビジネスメディアScrip（スクリップ）とは？ https://www.citeline.com/ja-jp/products-services/commercialization/scrip

Closed Loop Medicine: Pairing Software With Drugs To Optimize Dosing

Wed, 22 May 2024 14:31:04 -0000

In this episode of the In Vivo podcast, Hakim Yadi, CEO and co-founder of UK techbio company Closed Loop Medicine, discusses how his company is pairing software and predictive analytics with medications old and new to tailor drug dosing to each patient.

Leading PRO Discusses Plans For Administering State EPR Programs

Tue, 21 May 2024 20:41:14 -0000

In this episode, HBW chats with John Hite of the leading producer responsibility organization administering three Extended Producer Responsibility laws launching next year. With a 1 July deadline to register for his PRO, Circular Action Alliance, Hite discusses steps companies should take now, how his organization will assist producers and expectations on fee collection.

개발 VS 딜메이킹: 블록버스터 신약을 확보하는 방법 (Korean-language podcast)

Tue, 21 May 2024 01:21:25 -0000

빅파마 기업들의 블록버스터 신약 확보 전략에 대한 Scrip 기사를 요약한 내용입니다. https://scrip.citeline.com/SC150256/Development-Versus-Dealmaking-How-To-Obtain-A-Blockbuster Playlist: https://soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini

How To Grow A Consumer Health Brand, With TheOTCLab’s Albert Swane

Mon, 20 May 2024 14:28:07 -0000

In this episode, HBW Insight catches up with Albert Swane, founder and CEO of Dutch consumer healthcare firm, TheOTCLab, to talk about business strategy. Having grown the company with widely successful European OTC medical devices like Dr. Yglo, FungeX and Kidsner, Swane is perfectly placed to explain how to create and grow OTC brands. Swane also offers some sage advice on partnering, reflects on the fantastic opportunity of TheOTCLabs expanding into the US, and shares his experiences of using social media to raise the profile of the OTC industry.

Scrip's Five Must-Know Things - 20 May 2024

Mon, 20 May 2024 03:48:57 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 17 May 2024. In this episode: the life of a blockbuster; blockbusters by indication; gene therapy struggles; sun shines on AstraZeneca and GSK; and Korean ventures look to Japan. https://scrip.citeline.com/SC150281/Quick-Listen-Scrips-Five-MustKnow-Things Playlist: https://soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Drug Fix: BIOSECURE Act Advances, Trial Diversity Sticks, Platform Principles Without Designation

Fri, 17 May 2024 18:08:19 -0000

Pink Sheet editors and reporter consider the implications of the BIOSECURE Act as it advances through a House committee (:30), whether industry would improve clinical trial diversity with tougher enforcement of the regulation (22:26), as some have suggested, and the FDA’s use of platform technology ideas for gene therapies not participating in the program (33:07). More On These Topics From The Pink Sheet As Biosecure Bill Mores Forward, Clock Ticking For Industry To Move Away From Chinese CDMOs: https://pink.citeline.com/PS154707/As-Biosecure-Bill-Mores-Forward-Clock-Ticking-For-Industry-To-Move-Away-From-Chinese-CDMOs BIOSECURE Act Update Offers Biotech Companies Eight Years to Divest Contracts With Firms Of ‘Concern’: https://pink.citeline.com/PS154692/BIOSECURE-Act-Update-Offers-Biotech-Companies-Eight-Years-to-Divest-Contracts-With-Firms-Of-Concern Senate Work On Biosecurity Issues Continues Even As House Is Current Focus Of Legislative Activity: https://pink.citeline.com/PS154688/Senate-Work-On-Biosecurity-Issues-Continues-Even-As-House-Is-Current-Focus-Of-Legislative-Activity US FDA Asked To Tighten China Risk Control By Legislators As Markup Looms: https://pink.citeline.com/PS154675/US-FDA-Asked-To-Tighten-China-Risk-Control-By-Legislators-As-Markup-Looms ‘Do It Or We’re Not Going To Approve Your Drug:’ Industry Reps Ask FDA For Trial Diversity Sticks: https://pink.citeline.com/PS154696/Do-It-Or-Were-Not-Going-To-Approve-Your-Drug-Industry-Reps-Ask-FDA-For-Trial-Diversity-Sticks US FDA Using Platform Ideas Outside Of Formal Designations To Speed Cell and Gene Approvals: https://pink.citeline.com/PS154702/US-FDA-Using-Platform-Ideas-Outside-Of-Formal-Designations-To-Speed-Cell-and-Gene-Approvals

May 2024 Datamonitor Healthcare Podcast: Neoadjuvant Therapy in Melanoma

Fri, 17 May 2024 00:05:34 -0000

Flora gives an overview of the budding landscape of neoadjuvant therapy in melanoma and provides insight on the nuances of this market. Apple Podcasts -   https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836 Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU1NDkyOC9zb3VuZHMucnNz TuneIn - https://tunein.com/podcasts/Business--Economics-Podcasts/Pharma-Intelligence-Podcasts-p1140128/ Spotify Podcasts - https://open.spotify.com/show/3DTc3eIh4xI6pVOd6DdO67

China Biotech Podcast - 15 May 2024 (Chinese- and English-Language)

Wed, 15 May 2024 07:25:59 -0000

In this bilingual Chinese- and English-language edition, China-based editors Brian Yang and Dexter Yan, along with guest speaker Derrick Gingery from the Pink Sheet in the US, discuss the planned US BIOSECURE Act and markup vote. Brian and Dexter also look at recent R&D updates from Chinese biopharma firms on their antibody-drug conjugate pipelines. https://scrip.citeline.com/SC150255/China-Biotech-Podcast-BIOSECURE-Markup-Biotech-Pipeline-Updates Other podcasts in the series: https://soundcloud.com/citelinesounds/sets/chinese-language-biopharma

Scrip's Five Must-Know Things - 13 May 2024

Mon, 13 May 2024 05:46:20 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 10 May 2024. In this episode: AstraZeneca’s Vaxzevria farewell; the next wave of cardiometabolics; Pfizer recruits prominent analyst: foundation pleas for China rare disease therapies; and Gossamer partners up for respiratory therapy. https://scrip.citeline.com/SC150240/Quick-Listen-Scrips-Five-MustKnow-Things Playlist: https://soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Episode 15: Digital Trust

Thu, 09 May 2024 19:42:25 -0000

In this episode, Medtech Insight senior reporter Hannah Daniel speaks to Mark Brown, Global Managing Director of Digital Trust Consulting at the British Standards Institute about digital trust. In a world of cybersecurity breaches and ransomware attacks on hospitals, digital trust between companies and consumers is key, but current siloed operations can hinder that. We talk about the EU’s AI act, the speed of digital transformation, cybersecurity incentives, and how principle-based regulations are better than prescriptive ones.

Solving The Sustainable Pill Pack Puzzle, With PA Consulting’s Tony Perrotta

Tue, 07 May 2024 16:24:20 -0000

In this episode, HBW Insight chats with sustainable packaging expert Tony Perrotta about why it’s so difficult to replace plastic pill packs in medicines packaging. Perrotta works for PA Consulting, which set up the Blister Pack Collective alongside consumer healthcare partners Haleon, Bayer and Sanofi. They are working with PulPac, which has invented a dry molded fiber alternative to plastic, which the collective hopes will be ready to commercialize in the next 12-24 months. We discuss whether regulators will accept such alternatives, given the safety and stability requirements for medicines, and the challenges of recycling, given the multitude of different frameworks and processes across the world. Perrotta also reveals that one of the partners in PA Consulting’s Bottle Collective, which also hopes to use the same dry molded fiber technology to replace plastic bottles in food, personal care and consumer health industries, will soon be launching its first market trial.

Scrip's Five Must-Know Things - 7 May 2024

Tue, 07 May 2024 02:44:27 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 3 May 2024. In this episode: Japan’s Ono buys US oncology firm; strong growth but supply issues for Lilly; Novo and Lilly make their money work; BMS cuts jobs, costs; and Big Pharma’s support for bioventures. https://scrip.citeline.com/SC150211/Quick-Listen-Scrips-Five-MustKnow-Things More podcasts in this series: https://soundcloud.com/citelinesounds/sets/scrips-five-must-know-things?si=17107bcf40ad4c54b5148e7f58f28b69&utm_source=clipboard&utm_medium=text&utm_campaign=social_sharing

Drug Fix: US FDA Adcomm Reform, A Boost For Clinical Trial Modeling, AI For Drug Review

Fri, 03 May 2024 17:21:54 -0000

Pink Sheet reporter and editors discuss what an upcoming listening session means for the FDA’s advisory committee reform effort (:32), the agency’s efforts to help the clinical trial modeling and simulation industry (16:22), and the UK’s MHRA plan to use artificial intelligence to assist in drug application reviews (21:05). More On These Topics From The Pink Sheet US FDA Adcomm Reform: Does Listening Session Suggest No Major Near-Term Changes?: https://pink.citeline.com/PS150167/US-FDA-Adcomm-Reform-Does-Listening-Session-Suggest-No-Major-Near-Term-Changes US FDA Wants Advice About Advisory Committees: Try Having Some?: https://pink.citeline.com/PS154644/US-FDA-Wants-Advice-About-Advisory-Committees-Try-Having-Some US FDA Developing Model Master File System To Grow Modeling, Simulation Field: https://pink.citeline.com/PS154647/US-FDA-Developing-Model-Master-File-System-To-Grow-Modeling-Simulation-Field UK’s MHRA To Use AI In Regulatory Review Process & RWD Analysis: https://pink.citeline.com/PS154643/UKs-MHRA-To-Use-AI-In-Regulatory-Review-Process--RWD-Analysis More podcasts from the Pink Sheet: https://soundcloud.com/citelinesounds/sets/podcasts-from-the-pink-sheet?si=a64a3c5c834a470ca9e71dc19777df04&utm_source=clipboard&utm_medium=text&utm_campaign=social_sharing

Digital Health Roundup: US FDA’s ‘Idea Lab’; Philips’ Roy Jakobs On AI Draft Framework; Apple Watch

Tue, 30 Apr 2024 22:29:19 -0000

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights key interviews with Philips’ CEO Roy Jakobs on NAM’s draft framework on AI, BD’s CTO Beth McCombs R&D initiatives and HSS spine co-chair Sheeraz Qureshi on his vision for integrating AI tech. Hannah Daniel discusses the FDA’s new initiative to create an idea lab for medical device use at home and Apple Watch’s new feature to help people with Parkinson’s disease. Listen to the podcast via the player below: Medtech Insight articles addressing topics discussed in this episode: BD’s CTO Beth McCombs Discusses Key Initiatives – AI/Gen AI; DE&I Strategy; Succession Planning HSS Spine Surgeon Sees Potential For AI Chatbots, But Not To ‘Practice Medicine’ Philips Portfolio Includes ‘No Single Product That Does Not Use A Type of AI,’ Says CEO and AI Thought Leader Roy Jakobs Discreet Gait Freezing Solution Brings Therapy With The Tap Of An Apple Watch CDHR’s AR/VR Home Space Will Serve As An ‘Idea Lab’ For Device Stakeholders

April Datamonitor Podcast 2024: AAN coverage

Tue, 30 Apr 2024 16:44:52 -0000

Flora and Emma are joined by Datamonitor’s CNS analysts Summer, Joseph, and Wen-Yu to discuss coverage from AAN. Other platforms (in addition to SoundCloud): Apple Podcasts -   https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836 Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU1NDkyOC9zb3VuZHMucnNz TuneIn - https://tunein.com/podcasts/Business--Economics-Podcasts/Pharma-Intelligence-Podcasts-p1140128/ Spotify Podcasts - https://open.spotify.com/show/3DTc3eIh4xI6pVOd6DdO67

Scrip's Five Must-Know Things - 30 April 2024

Tue, 30 Apr 2024 02:58:06 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 26 April 2024. In this episode: 2023’s top selling drugs and the COVID cliff; falling sales force Roche to reassess priorities; Phase III immunology win for Sanofi; BMS’s strong pipeline: and which companies could be acquired next. https://scrip.citeline.com/SC150182/Quick-Listen-Scrips-Five-MustKnow-Things

2024 Global Generics & Biosimilars Awards

Mon, 29 Apr 2024 13:39:02 -0000

2024 Global Generics & Biosimilars Awards by Citeline

Podcast: Facilitating Patient Monitoring in CAR-T Development

Mon, 29 Apr 2024 10:51:17 -0000

Learn how molecular technology is enhancing patient safety for CAR-T clinical trials. US FDA recently initiated class safety labeling changes after evaluating the safety of CAR-T cancer treatment therapies. What does this mean for developers in the CAR-T landscape? Listen to your free podcast to find out. Listen in on the conversation as experts from Cerba discuss facilitating patient safety measures in CAR-T therapies by accurately identifying the integration of viral vectors, utilizing flow cytometry, and more. Listen now as experts discuss answers to: · What patient monitoring is required by the FDA? · What molecular technology does Cerba use and how does it meet FDA requirements? · What is the importance of cytometry assays in monitoring CAR-T cells? · What are the opportunities for combining flow cytometry with genomic solutions? · What key innovations are poised to improve patient monitoring in clinical trials?

Drug Fix: US FDA Biosimilar Strategy, Gene Therapy Accelerated Approvals, FDA v. Partisan Politics

Fri, 26 Apr 2024 18:08:04 -0000

Pink Sheet reporter and editors discuss the impact of FDA biosimilar promotion guidance on the future of the interchangeability designation (:34), upcoming guidance on accelerated approval for gene therapies (14:15), and partisan attacks on the agency from Capitol Hill (27:13). More On These Topics From The Pink Sheet Rx Advertising: Interchangeability Doesn’t Mean Clinical Superiority To Other Biosimilars, FDA Says: https://pink.citeline.com/PS150143/Rx-Advertising-Interchangeability-Doesnt-Mean-Clinical-Superiority-To-Other-Biosimilars-FDA-Says US FDA Gene Therapy Accelerated Approval Guidance Will Describe ‘Buckets’ Of Use Scenarios: https://pink.citeline.com/PS150140/US-FDA-Gene-Therapy-Accelerated-Approval-Guidance-Will-Describe-Buckets-Of-Use-Scenarios Partisan Politics Returns To US FDA Congressional Oversight: https://pink.citeline.com/PS150114/Partisan-Politics-Returns-To-US-FDA-Congressional-Oversight

Dr. Xue Discusses Treatment Guideline Updates for COPD in This Q&A Session

Fri, 26 Apr 2024 15:28:20 -0000

Pulmonologist Bing Xue, MD, reviews the latest GOLD guidelines and discusses relevant topics regarding COPD treatment.

China Biotech Podcast - 26 April 2024 (Chinese and English Language)

Fri, 26 Apr 2024 07:02:40 -0000

Join Scrip's China-based editors Brian Yang and Dexter Yan in this Chinese/English podcast as they look at data presented to AACR by Chinese pharma firms and recent acquisitions of China-based companies. UK-based writer Andrew McConaghie also joins to provide his perspectives, including on the proposed US BIOSECURE Act. https://scrip.citeline.com/SC150164/China-Biotech-Podcast-AACR-BIOSECURE-European-Perspectives

Future Governance & Oversight of the EU Medtech Regulatory System

Wed, 24 Apr 2024 10:46:19 -0000

Does the EU need a medtech agency for the first time in its history? Nothing can or should be decided too quickly but five high-profile experts broadly agreed that change is now critical.

Citeline - Cerba Research Podcast V2

Tue, 23 Apr 2024 16:29:41 -0000

Citeline - Cerba Research Podcast V2 by Citeline

Scrip M&A Podcast: Are Buyers Coming For Viking, Verona, Altimmune, Xenon And Crinetics

Tue, 23 Apr 2024 14:27:03 -0000

Scrip's Joseph Haas, Kevin Grogan and Edwin Elmhirst talk about the biopharma M&A environment and which companies might look particularly appealing to potential acquirers.

Turning That Frown Upside Down: Treating Depression With Facial Botox Injections

Mon, 22 Apr 2024 17:59:07 -0000

In this episode of the In Vivo podcast, Eric Finzi, CEO of Healis Therapeutics, discusses how his company is targeting major depression, post-traumatic stress disorder and other mental illnesses using facial botox injections.

Helping Consumers ‘Tune In’ To Reliable Health Information, With Kaizo’s Anita Nahal

Mon, 22 Apr 2024 12:24:22 -0000

Helping Consumers ‘Tune In’ To Reliable Health Information, With Kaizo’s Anita Nahal “Consumers are rewriting the rules when it comes to where they are going for information and the type of information they are looking for,” reports Kaizo’s Anita Nahal, speaking to HBW Insight’s Over the Counter podcast about the agency’s latest Communicating Health Messages report. Trust in social media has increased, and personal beliefs and lived experiences are playing a larger role in shaping attitudes to health information, explains Nahal, who is director at the London-based PR agency. However, consumers are also continuing to “tune-out” from health messages and be less critical of sources. To help consumers navigate this new reality, consumer health companies need to adapt, rethink and reset their communication strategies, Nahal advises.

Scrip's Five Must-Know Things - 22 April 2024

Mon, 22 Apr 2024 02:41:19 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 19 April 2024. In this episode: Teva’s immunology biosimilar launches; Intra-Cellular’s promising depression data; Phase III sleep apnea win for Lilly’s tirzepatide; an interview with Viking’s CEO; and China looks to define innovative drugs. https://scrip.citeline.com/SC150134/Quick-Listen-Scrips-Five-MustKnow-Things Other podcasts in this series: https://on.soundcloud.com/xSKGyTJnAYS66apP9

Drug Fix: Leqembi Spending, Woodcock’s Next Act, Pneumococcal Vaccine Development

Fri, 19 Apr 2024 17:31:10 -0000

Pink Sheet editors discuss Medicare spending projections for the Alzheimer’s treatment Leqembi (:28), Janet Woodcock’s new post-FDA role (12:28), and ongoing preparations for new pneumococcal vaccines that will reach the market soon (17:28). #business #pharma More On These Topics From The Pink Sheet Medicare Spending Forecast For Leqembi Reflects CMS Angst About Alzheimer’s Drug Costs: https://pink.citeline.com/PS150095/Medicare-Spending-Forecast-For-Leqembi-Reflects-CMS-Angst-About-Alzheimers-Drug-Costs Woodcock Takes On Rare Disease Challenges In Retirement, Keeps FDA, Industry At Arm’s Length: https://pink.citeline.com/PS150111/Woodcock-Takes-On-Rare-Disease-Challenges-In-Retirement-Keeps-FDA-Industry-At-Arms-Length Change Is Constant For Pneumococcal Vaccines: US CDC Prepares For Merck’s V116: https://pink.citeline.com/PS150029/Change-Is-Constant-For-Pneumococcal-Vaccines-US-CDC-Prepares-For-Mercks-V116

Next-Generation Diagnostics: "Breathomics" From Imspex

Fri, 19 Apr 2024 14:11:08 -0000

A new diagnostic technology to screen and triage individuals based on breath.

Ratio Therapeutics On BMS Buy-In, Radiopharma R&D Trends, AI And Assets

Tue, 16 Apr 2024 00:24:31 -0000

Scrip’s senior editor Vibha Ravi speaks with Jack Hoppin, CEO and chairman, and John Babich, chief scientific officer, at Ratio Therapeutics, about the company’s radiopharmaceuticals pipeline, investment by BMS, use of AI, trends and developments in radiopharma research like combining ADCs or PARP inhibitors and more. https://scrip.citeline.com/SC150098/Ratio-Therapeutics-On-BMS-Investment-Radiopharma-RD-Trends-AI-Use

China Biotech Podcast (Chinese- and English-language) - April 2024

Mon, 15 Apr 2024 04:41:13 -0000

In this Chinese- and English-language episode, guest speaker Treehill Partners co-founder Ali Parshadezah joins Brian Yang and Dexter Yan to discuss updates on the proposed US BIOSECURE Act and US-China biotech movements, including recent M&A activity. https://scrip.citeline.com/SC150090/China-Biotech-Podcast-BIOSECURE-Updates-GenmabProfound-Deal

Scrip's Five Must-Know Things - 15 April 2024

Mon, 15 Apr 2024 02:27:27 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 12 April 2024. In this episode: the shifting sands of pharma R&D; big pharma oncology strategies; semaglutide’s promise in heart failure; AstraZeneca looks to multiple cancer modalities; and an interview with Astellas’s chief strategy officer. https://scrip.citeline.com/SC150097/Quick-Listen-Scrips-Five-MustKnow-Things

Drug Fix: US FDA Adcomm Open Public Hearings, Clinical Trial Diversity Plans, Stealth’s Elamipretide

Fri, 12 Apr 2024 17:05:28 -0000

Pink Sheet reporter and editors discuss Richard Pazdur’s call for more diverse opinions in FDA advisory committee meeting open public hearings (:36), agency questions about the stakeholders sponsors consult to execute clinical trial diversity plans (20:52), and Stealth BioTherapeutics’ application for the Barth Syndrome candidate elamipretide getting reviewed (32:23). More On These Topics From The Pink Sheet Adcomm Open Public Hearings Have Become Too Sponsor-Driven – US FDA's Pazdur: https://pink.citeline.com/PS150077/Adcomm-Open-Public-Hearings-Have-Become-Too-SponsorDriven--US-FDAs-Pazdur Clinical Trial Diversity Requires Sponsors Work With An Assortment Of Patient Advocates, Community Organizations: https://pink.citeline.com/PS150081/Clinical-Trial-Diversity-Requires-Sponsors-Work-With-An-Assortment-Of-Patient-Advocates-Community-Organizations Stealth’s Elamipretide Gets US FDA Review, But Same Questions Linger: https://pink.citeline.com/PS150070/Stealths-Elamipretide-Gets-US-FDA-Review-But-Same-Questions-Linger

In Conversation With 2024 In Vivo Rising Leader, Hanadie Yousef

Tue, 09 Apr 2024 13:49:54 -0000

In this episode, In Vivo speaks to 2024 Rising Leader Hanadie Yousef, CEO of Juvena Therapeutics, about her journey, the secretome as a source of therapeutics, longevity medicine and alternatives to GLP-1 inhibitors for obesity.

Scrip's Five Must-Know Things - 8 April 2024

Mon, 08 Apr 2024 03:19:21 -0000

Audio roundup of selected biopharma industry content from Scrip over the business week ended 5 April 2024. In this episode: Genmab buys into ADCs; Roivant set to take on AbbVie in uveitis; Ipsen signs firs ADC pact; South Korea looks to build biotech momentum; and the end of the road for Acorda. https://scrip.citeline.com/SC150062/Quick-Listen-Scrips-Five-MustKnow-Things

Drug Fix: Relyvrio And Public Promises, Allergy Biomarker Adcomms, PMDA In The USA

Fri, 05 Apr 2024 16:10:47 -0000

Pink Sheet reporters and editor discuss the implications of Amylyx following through on its pledge to remove Relyvrio from the market after its trial failed (:32), an FDA idea to bring potential biomarkers for promising allergy and asthma treatments to advisory committees (9:08), and Japan’s PMDA opening an office in Washington D.C. (16:19). More On These Topics From The Pink Sheet Amylyx’s Relyvrio Withdrawal May Trigger More Public Pledges Based On Confirmatory Trial Data: https://pink.citeline.com/PS150060/Amylyxs-Relyvrio-Withdrawal-May-Trigger-More-Public-Pledges-Based-On-Confirmatory-Trial-Data US FDA Envisions Advisory Committees For Allergy, Asthma Biomarkers With ‘Real Impact’: https://pink.citeline.com/PS149915/US-FDA-Envisions-Advisory-Committees-For-Allergy-Asthma-Biomarkers-With-Real-Impact Breaking Barriers: Japan's PMDA To Open First Global Office, In D.C.: https://pink.citeline.com/PS150044/Breaking-Barriers-Japans-PMDA-To-Open-First-Global-Office-In-DC

Medtech Connect Episode 14: Live From HIMSS 2024

Wed, 03 Apr 2024 18:43:15 -0000

In this episode, Medtech Insight regulatory reporter Hannah Daniel speaks to industry professionals at the Healthcare Information and Management Systems Society (HIMSS) 2024 conference about what they enjoy about the annual gathering and what excites them for the future.

피노바이오, 국내 ADC 생태계 발전에 기여할 것 (Korean-language podcast)

Tue, 02 Apr 2024 02:25:08 -0000

기술 수요와 공급의 '불균형' 속에서 국내 ADC 업체들은 생태계를 발전시키려 노력하고 있습니다. Scrip의 정두영 피노바이오 대표 인터뷰기사를 요약한 내용입니다. https://scrip.citeline.com/SC149716/How-Pinotbio-Is-Helping-Build-Koreas-ADC-Ecosystem

Scrip's Five Must-Know Things - 1 April 2024

Mon, 01 Apr 2024 02:29:59 -0000

Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: Merck & Co progresses cardiovascular strategy; Novo purchase builds heart failure presence; CRL setbacks for Regeneron; ITF faces challenging Duchenne field; and AbbVie needs to freshen up. https://scrip.citeline.com/SC150030/Quick-Listen-Scrips-Five-MustKnow-Things

Analysing The Spin-Out Trend In Consumer Health, With HBW’s Malcolm Spicer And Tom Gallen

Thu, 28 Mar 2024 12:57:55 -0000

In this episode, HBW Insight’s Europe and US editors Tom Gallen and Malcolm Spicer bring their expertise to bear on the current the trend towards standalone OTC companies in global consumer health. We look at four major players: Haleon, which separated from GSK almost two years ago, Kenvue, soon to celebrate its first anniversary as a new company; Sanofi, which has announced it will be exiting the OTC market by divesting its OTC business and Bayer, which has decided to buck the trend, holding on to its consumer health division. We discuss some of the possible advantages of becoming a standalone company, for example in leaning into a wider concept of self-care.

March Datamonitor Podcast 2024: The US Inflation Reduction Act

Wed, 27 Mar 2024 15:49:05 -0000

Flora and Ian are joined by Datamonitor’s financial analyst Abby, who discusses the Inflation Reduction Act and drug pricing trends in the US. Other platforms (in addition to SoundCloud): Apple Podcasts -   https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836 Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU1NDkyOC9zb3VuZHMucnNz TuneIn - https://tunein.com/podcasts/Business--Economics-Podcasts/Pharma-Intelligence-Podcasts-p1140128/ Spotify Podcasts - https://open.spotify.com/show/3DTc3eIh4xI6pVOd6DdO67

Scrip's Five Must-Know Things - 26 March 2024

Tue, 26 Mar 2024 02:52:53 -0000

Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: another big deal in radiopharmaceuticals; BioNTech’s ADC pipeline; China CDMOs embrace uncertain future; at look at the rivals in MASH; and industry views on how AI might be transformative. https://scrip.citeline.com/SC150008/Quick-Listen-Scrips-Five-MustKnow-Things

Drug Fix: Mifepristone And Misinformation At SCOTUS, Understanding US FDA’s ODAC

Fri, 22 Mar 2024 17:14:32 -0000

Pink Sheet reporters and editor discuss the upcoming US Supreme Court arguments on mifepristone access (:34), the SCOTUS reaction to the fight against misinformation (18:28), and the FDA’s Oncologic Drugs Advisory Committee going against three negative product reviews (31:23). More On These Topics From The Pink Sheet Mifepristone Supporters Highlight Voter Trust In FDA Decisions Ahead Of Supreme Court Arguments: https://pink.citeline.com/PS149998/Mifepristone-Supporters-Highlight-Voter-Trust-In-FDA-Decisions-Ahead-Of-Supreme-Court-Arguments US FDA’s Anti-Misinformation Campaigns Look Safer After Supreme Court Oral Arguments: https://pink.citeline.com/PS149985/US-FDAs-Anti-Misinformation-Campaigns-Look-Safer-After-Supreme-Court-Oral-Arguments The Dog That Didn’t Bark: ODAC Gives Nod To Three Products Despite Negative FDA Reviews: https://pink.citeline.com/PS149961/The-Dog-That-Didnt-Bark-ODAC-Gives-Nod-To-Three-Products-Despite-Negative-FDA-Reviews Eye On ODAC: Former Members, FDA’s Pazdur Talk Pre-Meeting Mindsets, Impact Of Sponsor’s Experts: https://pink.citeline.com/PS149995/Eye-On-ODAC-Former-Members-FDAs-Pazdur-Talk-PreMeeting-Mindsets-Impact-Of-Sponsors-Experts

China Biotech Podcast (Chinese language) - March 2024

Fri, 22 Mar 2024 09:07:46 -0000

Guest speaker Kevin Duan joins Brian Yang and Dexter Yan to discuss the proposed US BIOSECURE Act, the US FDA's approval of a China-origin anti-PD-1 drug and the latest developments in the antibody-drug conjugate area.

Digital Health Roundup: EU’s AI Act Impact; Verily's Andrew Trister’s Vision For Personal AI Agent

Wed, 20 Mar 2024 02:38:18 -0000

Listen to the podcast via the player below: Medtech Insight articles addressing topics discussed in this episode: In Five Years, People Will Navigate Their Health Care With An AI-Advisor – Verily’s Andrew Trister Verily’s Andrew Trister On Uniting The Pieces To Create Personalized Health, Equity European Parliament Adopts AI Act, But Success Hangs On The AI Office AI Clinical Summarization Tools Sit In 'Regulatory Grey Area', Experts Warn

Scrip's Five Must-Know Things - 18 March 2024

Mon, 18 Mar 2024 02:37:49 -0000

Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: Galderma prepares to take on Dupixent; Pfizer’s plans for Adcetris in DLBCL; Lilly’s donanemab approval delayed again; the psychedelic R&D pipeline; and an interview with BMS’s CDTO Greg Meyers. https://scrip.citeline.com/SC149962/Quick-Listen-Scrips-Five-MustKnow-Things

How AI Is Revolutionizing Personalized Wellness, With Bioniq’s Marni Allen

Fri, 15 Mar 2024 15:30:43 -0000

In this episode, HBW Insight dives into personalized wellness with Marni Allen, chief marketing officer at tailored supplements manufacturer Bioniq. Named as one of EY UK's 50 Women to Watch in 2022, Allen has over 20 years’ experience in consumer healthcare, and is now working with Bioniq to create the next generation of bespoke wellness products for consumers across the world. As well as its top tier at-home blood test-based service, Bioniq also offers an affordable questionnaire-based option, which leverages the power of AI to analyse users’ nutritional needs and provide unique supplement formulations in the post. Although personalized wellness is still somewhat niche, Allen suggests that AI-based models like Bioniq offer an attractive option for traditional consumer health companies looking to get into this fast-growing market.

【3分で解説世界のファーマ】第17回 LSDで不安症を治療第III相開始へ (Japanese-language podcast)

Wed, 13 Mar 2024 01:58:34 -0000

Summary: 今回取り上げた記事はこちら「MindMed Ready To Take LSD Therapy Into Phase III For Anxiety（MindMed、LSD療法を不安症治療の第III相治験へ）」 https://www.citeline.com/ja-jp/resources/mindmed-ready-to-take-lsd-therapy-into-phase-iii-for-anxiety ※全文の閲覧には情報の登録（無料）が必要です。世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。 (英語版) https://scrip.citeline.com/SC149912/MindMed-Ready-To-Take-LSD-Therapy-Into-Phase-III-For-Anxiety ※全文の閲覧には購読（有料）が必要です。世界の製薬ビジネスメディアScrip（スクリップ）とは？ https://www.citeline.com/ja-jp/products-services/commercialization/scrip

"Identifying The 80% Of Undiagnosed And Misdiagnosed Patients"

Mon, 11 Mar 2024 15:13:45 -0000

Vibhor Gupta, director and founder of Pangaea Data, talks to In Vivo about the value of identifying the 80% of patients with undiagnosed or misdiagnosed conditions, and how his company is addressing this need.

Scrip's Five Must-Know Things - 11 March 2024

Mon, 11 Mar 2024 02:33:21 -0000

Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: Bayer won’t split, for now; Pfizer’s next-gen ADC pipeline; oncology dominates investment but other areas grow; goodbye NASH, hello MASH; and BMS’s CEO gives his views on India. Links to the stories discussed are here: https://scrip.citeline.com/SC149924/Quick-Listen-Scrips-Five-MustKnow-Things

Drug Fix: Vanda Appeals US FDA Jet Lag Denial In Court, Mark Cuban Battles PBMs, Austere FDA Budget

Fri, 08 Mar 2024 15:11:44 -0000

Pink Sheet reporters and editor discuss Vanda’s decision to sue the FDA over the rejection of the Hetlioz jet lag indication (:30), Mark Cuban’s comments at a White House event that the federal government and others should stop doing business with the big three PBMs (11:50), and the cut in non-user fee dollars in the FY 2024 FDA appropriations bill (24:49). More On These Topics From The Pink Sheet Vanda Appeals FDA’s Denial Of Hetlioz Jet Lag Application As It Is Hit With CRL For Insomnia: https://pink.citeline.com/PS149914/Vanda-Appeals-FDAs-Denial-Of-Hetlioz-Jet-Lag-Application-As-It-Is-Hit-With-CRL-For-Insomnia Mark Cuban: Pharma’s Secret Weapon In The Fight Against PBMs: https://pink.citeline.com/PS149899/Mark-Cuban-Pharmas-Secret-Weapon-In-The-Fight-Against-PBMs Congress Gives US FDA Austere Budget But Seeks Boosts On Inspections, IT, And ALS Activities: https://pink.citeline.com/PS149897/Congress-Gives-US-FDA-Austere-Budget-But-Seeks-Boosts-On-Inspections-IT-And-ALS-Activities

Scrip이 묻다: 2024년 제약바이오업계 전망은? 치료영역의 발전 (Korean-language podcast)

Thu, 07 Mar 2024 07:40:51 -0000

2024년 글로벌 전문가들이 예측하는 치료영역의 발전은 무엇인 지에 대한 Scrip 기사를 요약한 내용입니다 https://scrip.citeline.com/SC149780/Scrip-AsksWhat-Does-2024-Hold-For-Biopharma-Part-6-Therapeutic-Area-Advances

Medtech Connect Episode 13: Augmented Reality In Surgery

Thu, 07 Mar 2024 01:21:23 -0000

In this episode, US regulatory reporter Hannah Daniel speaks to Ocutrx CEO Michael Freeman about augmented reality in medical products and their not-so-unique regulatory requirements.

Scrip's Five Must-Know Things - 4 March 2024

Mon, 04 Mar 2024 03:37:11 -0000

Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: optimistic outlook for biopharma IPOs; Boehringer’s promising MASH results; Viking emerges as obesity contender; Incyte looks to portfolio diversification; and a look at China’s HPV vaccine market. https://scrip.citeline.com/SC149879/Quick-Listen-Scrips-Five-MustKnow-Things

Cardio Conversations: iRhythm CEO Blackford Talks AI Arrhythmia Diagnostics

Mon, 04 Mar 2024 00:06:29 -0000

iRhythm CEO Quentin Blackford returns to Medtech Insight’s Cardio Conversations podcast to talk about the launch of the company’s new Monitor long-term cardiac monitoring patch, the company's plans for the MCT market, and a lot more.

The Emerging Benefits Of ‘Beauty-From-Within,’ Featuring Kenvue’s Paul LaTerra

Fri, 01 Mar 2024 17:02:21 -0000

In this episode of Over the Counter, HBW Insight speaks to Paul LaTerra, Director, R&D, Global Hair and Scalp for Kenvue, a New Jersey-based consumer health company that markets skin care brands Neutrogena, Aveeno and Lubriderm. We discuss growth of the beauty-from-within supplements market, how the products complement topical skin care and hair formulas and the growing body of research demonstrating significant skin and hair health benefits.

February Datamonitor Podcast: 2024 Clinical Outlook

Wed, 28 Feb 2024 16:28:55 -0000

Emma and Flora outline expected trends and exciting upcoming events across therapy areas for 2024, straight from the subject matter experts at Datamonitor. Other platforms (in addition to SoundCloud): Apple Podcasts -   https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836 Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU1NDkyOC9zb3VuZHMucnNz TuneIn - https://tunein.com/podcasts/Business--Economics-Podcasts/Pharma-Intelligence-Podcasts-p1140128/ Spotify Podcasts - https://open.spotify.com/show/3DTc3eIh4xI6pVOd6DdO67

NodThera On The Role Of The Brain In Driving Chronic Disease

Wed, 28 Feb 2024 09:38:46 -0000

Alan Watt, CEO of NodThera, a clinical-stage biotech developing brain-penetrant NLRP3 inflammasome inhibitors to treat chronic inflammatory diseases, talks to In Vivo about the company’s pipeline and recent data publication in the field of obesity. The company is focused on developing drugs that inhibit the NLRP3 inflammasome, a validated drug target that plays a pivotal role in controlling inflammatory diseases. It has two clinical trials ongoing – both Phase Ib/IIa – in Parkinson’s disease and for cardiovascular risk in obese patients.

Scrip's Five Must-Know Things - 26 February 2024

Mon, 26 Feb 2024 04:53:32 -0000

Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: Bayer takes strategic steps to cut debt; AbbVie confirms internal appointment as CEO; another RIPK1 setback for Denali/Sanofi; new biotech reality in China; and ex-Daiichi Sankyo CEO shares insights into tough decisions. https://scrip.citeline.com/SC149846/Quick-Listen-Scrips-Five-MustKnow-Things

Drug Fix: US FDA And Psychedelic Drugs, Aduhelm Clinical Trial Data, Adcomm Candidates

Fri, 23 Feb 2024 18:07:34 -0000

Pink Sheet reporters and editors discuss the FDA’s approach to psychedelic drugs (:25), whether postmarket clinical trial data from the Alzheimer’s drug Aduhelm will be published (16:32), and the FDA offering more time to find candidates for its new Genetic Metabolic Diseases Advisory Committee (27:19). More On These Topics From The Pink Sheet Lykos’ MDMA NDA Leads Upcoming Tests Of US FDA’s Psychedelics Draft Guidance: https://pink.citeline.com/PS149813/Lykos-MDMA-NDA-Leads-Upcoming-Tests-Of-US-FDAs-Psychedelics-Draft-Guidance For Psychedelics, US FDA Is Open To Creative Thinking But Firm On Approval Standards: https://pink.citeline.com/PS149812/For-Psychedelics-US-FDA-Is-Open-To-Creative-Thinking-But-Firm-On-Approval-Standards A Visual Trip Through The Psychedelic Pipeline: https://pink.citeline.com/PS149831/A-Visual-Trip-Through-The-Psychedelic-Pipeline Aduhelm’s Post-Marketing Studies: At Least One More Data Dump Likely Required By NIH: https://pink.citeline.com/PS149826/Aduhelms-Post-Marketing-Studies-At-Least-One-More-Data-Dump-Likely-Required-By-NIH New US FDA Genetic Metabolic Adcomm Needs More Candidates: https://pink.citeline.com/PS149819/New-US-FDA-Genetic-Metabolic-Adcomm-Needs-More-Candidates

AESGP’s 60th Birthday Celebrations In 2024 Including Annual Meeting, With Jurate Švarcaite

Tue, 20 Feb 2024 08:37:45 -0000

The Association of the European Self-Care Industry celebrates its 60th birthday this year. In this episode, we catch up with AESGP director general, Jurate Švarcaite, to find out how the association will mark the occasion, including at this year’s Annual Meeting in Brussels in June. AESGP Annual Meetings are an excellent way to find out what the key issues and trends are impacting the European consumer health industry, and this one will be no different. We talk through some of the key themes of this year’s conference. Sustainability continues to be a mega-trend, closely followed by digitalization and artificial intelligence. With its wide-ranging footprint across OTC medicines, food supplements and self-care medical devices sectors, the consumer health industry is facing an avalanche of regulations, and the AESGP continues to be an effective advocate for its stakeholders, alongside adjacent industry partners.

Drug Fix: Price Negotiation Suit Tossed, Drug Shortage Probe, FDA-Approved Marijuana

Fri, 16 Feb 2024 18:03:41 -0000

Pink Sheet reporters and editors discuss the dismissal of PhRMA’s suit challenging the Medicare price negotiation provisions (:30), the US FTC and HHS investigation of drug shortages (12:01), and the potential for FDA-approved marijuana products (23:47). More On These Topics From The Pink Sheet PhRMA’s Lawsuit Against Medicare Trips Over ‘Administrative Remedy’ Standard; Will Others? https://pink.citeline.com/PS149791/PhRMAs-Lawsuit-Against-Medicare-Trips-Over-Administrative-Remedy-Standard-Will-Others FTC, HHS Probe GPO Contracting Practices As Source Of Generic Drug Shortages: https://pink.citeline.com/PS149790/FTC-HHS-Probe-GPO-Contracting-Practices-As-Source-Of-Generic-Drug-Shortages Prescription Marijuana? FDA Rescheduling Memo Sets Stage To Test Whether There’s A Viable Market: https://pink.citeline.com/PS149781/Prescription-Marijuana-FDA-Rescheduling-Memo-Sets-Stage-To-Test-Whether-Theres-A-Viable-Market

Drug Fix: State Of The Generic Industry, US FDA Under Second Trump Term, Inspections And Shortages

Fri, 09 Feb 2024 18:41:45 -0000

Pink Sheet reporter and editors discuss the issues and concerns raised during a major generic industry conference (:42), former FDA Commissioner Scott Gottlieb’s views on what a second Trump term as president would mean for the agency (13:54), and congressional hearings on FDA foreign manufacturing facility inspections and drug shortages (23:51). More On These Topics From The Pink Sheet ‘We Did Too Good Of A Job’ On Lowering Prices: Sandoz’s Haruvi Discusses Generic Sustainability: https://pink.citeline.com/PS149745/We-Did-Too-Good-Of-A-Job-On-Lowering-Prices-Sandozs-Haruvi-Discusses-Generic-Sustainability Blue Shield Of California’s Pharmacy Benefit Overhaul Could Still See Boost From Transparency Legislation: https://pink.citeline.com/PS149751/Blue-Shield-Of-Californias-Pharmacy-Benefit-Overhaul-Could-Still-See-Boost-From-Transparency-Legislation Gottlieb: FDA Would Be Subject To More White House Control Under A Second Trump Term: https://pink.citeline.com/PS149737/Gottlieb-FDA-Would-Be-Subject-To-More-White-House-Control-Under-A-Second-Trump-Term Congress Explores Plans For Catching Up On US FDA Foreign Inspections: https://pink.citeline.com/PS149744/Congress-Explores-Plans-For-Catching-Up-On-US-FDA-Foreign-Inspections Environmental Regulations May Create Barriers To Onshoring More Rx Manufacturing: https://pink.citeline.com/PS149749/Environmental-Regulations-May-Create-Barriers-To-Onshoring-More-Rx-Manufacturing

China Biotech Podcast (Chinese and English Language) - February 2024

Thu, 08 Feb 2024 01:45:56 -0000

Brian Yang, Dexter Yan and UK-based Kevin Grogan discuss Shanghai's new policy, draft US Biosecure bill, and multinationals AstraZeneca and Sanofi executives' views on China and Chinese innovation, along with other challenges. https://scrip.citeline.com/SC149758/China-Biotech-Podcast-Shanghai-Policy-US-Draft-Biosecure-Bill-MNCs-China-Strategy

혁신 육성 전략에 기반한 한국의 제약바이오 강국 야망 (Korean-language podcast)

Wed, 07 Feb 2024 02:54:40 -0000

박민수 보건복지부 2차관은 Citeline의 Pink Sheet과의 인터뷰에서 정부의 혁신적 R&D 우선순위와 이같은 목표 달성을 위한 과제, 바이오산업 투자심리 악화에 대한 대응책, 신약 개발 지원을 위한 규제 변화 등 다양한 이슈에 대해 이야기했습니다. https://pink.citeline.com/PS149348/Koreas-Powerhouse-Ambitions-Build-On-Innovation-Fostering-Policies

Trio Of Diagnostics Execs Weigh In On Upcoming Challenges

Tue, 06 Feb 2024 15:26:55 -0000

During this episode, Barnaby Pickering is joined by Rollie Carlson, CEO of Immunexpress, developer of Septicyte, a test for sepsis, Mark McDonough, CEO of ChromaCode, a company developing multiple blood-based tests for cancer diagnosis and treatment, with its first being in non-small cell lung cancer, and Lishan Aklog, CEO of Lucid Diagnostics, who have developed a cell-collection method that aims to bring forward the stage at which oesophageal cancer can be diagnosed. The group discuss the companies’ products and why they are transformative, as well as the upcoming regulatory and commercial hurdles awaiting diagnostics companies.

China Biotech Podcast - Interview With BeiGene Co-Founder Xiaodong Wang

Tue, 06 Feb 2024 05:40:07 -0000

Xiaodong Wang of major Chinese pharma firm BeiGene and China's National Institute of Biological Sciences shares views on China biotech innovation, BeiGene and next big thing with Scrip's Brian Yang.

Title: The Promise Of AI For Consumer Health, Pt 2, With The Exponential Club’s Nick Tate

Mon, 05 Feb 2024 09:24:13 -0000

HBW Insight continues its conversation with The Exponential Club’s Nick Tate. In this episode, we discuss what the future of consumer health might actually look like, covering a lot of ground from nudge-based health insurance platforms to digital products that may supplement or even replace traditional medicines. We also talk about the promise and limitations of at-home testing for furthering personalisation, and how to navigate partnerships with tech-specialists large and small to help accelerate digital transformation plans.

Scrip's Five Must-Know Things - 5 February 2024

Mon, 05 Feb 2024 04:27:20 -0000

Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: the biggest drug launches expected in 2024; Roche’s Pharma CEO talks about growth momentum; 10 pivotal studies to look out for this year; the obesity market now and in future; and what does 2024 hold for transformative technology in biopharma. https://scrip.citeline.com/SC149742/Quick-Listen-Scrips-Five-MustKnow-Things

Digital Health Roundup: CES Biggest Hits; Apple Versus Masimo; Insulet Recalls Diabetes App

Tue, 30 Jan 2024 22:13:22 -0000

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights interviews with industry leaders in medtech and healthtech and demos of some of the most innovative tech seen at CES 2024 in Las Vegas. Hannah Daniel dives into the latest developments in the intellectual property dispute between Apple and Masimo over blood oxygen sensors in the newer Apple Watch models. Medtech Insight articles addressing topics discussed in this episode: Dexcom COO On Stelo CGM Plans, Apple Watch Developments, And Why Non-Invasive Glucose Monitoring Still Leaves Much To Desire Abbott Lingo Leaders On Consumer Biowearable Outlook: ‘A Lot Of Appetite For Glucose As A Biomarker For Your Health’ CES Roundup: Holoportation, Empathic Robot, Aging Suit, Bionic Prosthetic Arm, Headband For Better Sleep Roundup: AI-Powered Assistive Hearing Devices Scream With Personalization; Femtech From Baby Makers To Menopause Apple Watches Are Back On The US Market News We’re Watching: Apple/Masimo Patent Fight Update Apple Drops Pulse Oximeter Features To Subvert Import Ban

Automating Cell Therapy Manufacturing: Cellular Origins' CEO Talks Robotics

Mon, 29 Jan 2024 15:19:17 -0000

In the latest episode of the In Vivo podcast, Edwin Stone, CEO of UK-based Cellular Origins, talks about how robotics can increase access to safe cellular therapies. The type of biology-agnostic robotics his company develops can help companies scale up cell manufacturing while lowering the cost of production.

Scrip's Five Must-Know Things - 29 January 2024

Mon, 29 Jan 2024 05:09:44 -0000

Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: Bayer’s pipeline refresh; J&J’s selective pharma M&A approach; silver lining for Gilead’s Trodelvy miss?; paying for obesity drugs; and the story behind Vertex and CRISPR’s gene therapy breakthrough. https://scrip.citeline.com/SC149699/Quick-Listen-Scrips-Five-MustKnow-Things

Medtech Connect Episode 12: Apple’s Patent Infringement Cases

Fri, 26 Jan 2024 21:11:26 -0000

Medtech Insight regulatory reporter Hannah Daniel speaks to Sanjay Voleti, AliveCor’s chief business officer, about his company’s patent infringement case against Apple and what it’s like to take on a tech giant over intellectual property.

Drug Fix: Janet Woodcock And The US FDA’s G.O.A.T., Puberty Blockers Meeting, CAR-T Safety

Fri, 26 Jan 2024 18:04:22 -0000

Pink Sheet reporters and editor discuss FDA Principal Deputy Commissioner Janet Woodcock’s place in the pantheon of FDA leaders (:27), an agency meeting with stakeholders on puberty blockers (23:55), and a new boxed warning for CAR-T therapies (35:42). More On These Topics From The Pink Sheet Immortalizing Janet Woodcock: https://pink.citeline.com/PS149666/Immortalizing-Janet-Woodcock On Puberty Blockers, FDA Is In ‘Listen Only’ Mode – For Now: https://pink.citeline.com/PS149679/On-Puberty-Blockers-FDA-Is-In-Listen-Only-Mode--For-Now CAR-Ts Getting Boxed Warning On Secondary Malignancies Despite Sponsor Causation Questions: https://pink.citeline.com/PS149673/CAR-Ts-Getting-Boxed-Warning-On-Secondary-Malignancies-Despite-Sponsor-Causation-Questions Kite’s Tecartus Boxed Warning Will More Closely Resemble Other CAR-Ts After FDA Changes Course: https://pink.citeline.com/PS149680/Kites-Tecartus-Boxed-Warning-Will-More-Closely-Resemble-Other-CAR-Ts-After-FDA-Changes-Course

Q&A Session on Treatment of LBCL With Oncologist Donald Fleming, MD

Mon, 22 Jan 2024 17:51:24 -0000

In this discussion, Dr. Fleming provides expert insight to questions about treating LBCL in elderly patients and those with comorbidities.

The Promise Of AI For Consumer Health, Pt 1, With The Exponential Club’s Nick Tate

Mon, 22 Jan 2024 08:15:46 -0000

In this episode, HBW Insight speaks to The Exponential Club’s Nick Tate about the impact of artificial intelligence and digitalization on consumer health and wellness. Having worked in both marketing and OTC, most recently leading Haleon’s incubator business, Haleon NEXT, Tate is perfectly placed to explain where industry is now with regards to digital health, and where it might be in the near future. The importance of data interoperability and of dialogue between governments, companies and consumers is discussed, along with ChatGPT and AI anxiety and the need for philosophers.

Drug Fix: US FDA Adcomm Schedule, CMS And Drug Importation, Missed User Fee Goals

Fri, 19 Jan 2024 18:04:54 -0000

Pink Sheet reporters and editors discuss the nearly wide open 2024 FDA advisory committee calendar, CMS’s impact on Florida’s drug importation plan, and the FDA’s many missed user fee goals in 2023. More On These Topics From The Pink Sheet The Sudden Stop In US FDA Advisory Committees: https://pink.citeline.com/PS149641/The-Sudden-Stop-In-US-FDA-Advisory-Committees Drug Importation And Medicaid: Trump Era Guidance Likely Disincentivizes Use: https://pink.citeline.com/PS149635/Drug-Importation-And-Medicaid-Trump-Era-Guidance- Likely-Disincentivizes-Use US FDA’s Missed User Fee Goals Spiked In 2023 – And Not Just Because Of COVID-19: https://pink.citeline.com/PS149629/US-FDAs-Missed-User-Fee-Goals-Spiked-In-2023--And-Not-Just-Because-Of-COVID-19

China Biotech Podcast - Major Takeaways From JPM (January 2024 - Chinese-Language)

Fri, 19 Jan 2024 08:03:14 -0000

VelaVigo founder and CEO Jing Li in Shanghai joins guest speaker Leon Tang in the US and Brian Yang in Beijing to discuss what stood out in this special JPM-focused episode of Scrip's Chinese-language podcast. https://scrip.citeline.com/SC149656/ChineseLanguage-Podcast-JPM-China-Biotech-Going-Global-2024-Outlook #pharma #biotech #JPM2024 #China #lifesciences

【3分で解説世界のファーマ】第16回 JPモルガンで見えた2024年の製薬業界 (Japanese-language podcast)

Fri, 19 Jan 2024 01:24:39 -0000

（日本語版）今回取り上げた記事はこちら「J.P. Morgan 2024: Optimism With An Undercurrent Of Tension（J.P.モルガン2024年：緊張をはらんだ楽観論）」 https://www.citeline.com/ja-jp/resources/jp-morgan-2024-optimism-with-an-undercurrent-of-tension ※全文の閲覧には情報の登録（無料）が必要です。世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。（英語版） https://scrip.citeline.com/SC149614/JP-Morgan-2024-Optimism-With-An-Undercurrent-Of-Tension ※全文の閲覧には購読（有料）が必要です。世界の製薬ビジネスメディアScrip（スクリップ）とは？ https://www.citeline.com/ja-jp/products-services/commercialization/scrip

Scrip's Five Must-Know Things - 15 January 2024

Mon, 15 Jan 2024 03:31:19 -0000

Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: major takeaways and highlights from the J.P. Morgan meeting; J&J bets on ADCs with Ambrx buy; the Indian GLP-1 battleground; and Scrip asks what 2024 holds for business strategy and leadership. https://scrip.citeline.com/SC149628/Quick-Listen-Scrips-Five-MustKnow-Things

Pennine Health Talks Sustainability Compliance and ESG Initiatives

Fri, 12 Jan 2024 17:47:32 -0000

Pennine Health Talks Sustainability Compliance and ESG Initiatives by Citeline

Drug Fix: Project Orbis For Gene Therapy, US FDA Leaders’ 2024 Predictions, FDA and AI

Fri, 12 Jan 2024 17:35:36 -0000

Pink Sheet reporter and editors discuss a new pilot project allowing collaborative reviews of gene therapies by multiple regulators (:42), predictions for the upcoming year by current and former US FDA leaders (11:12), and the FDA commissioner’s take on artificial intelligence (21:23). More On These Topics From The Pink Sheet Don’t Call It Project Orbis: CoGenT Global Will Pilot Collaborative Review Of Gene Therapies: https://pink.citeline.com/PS149607/Dont-Call-It-Project-Orbis-CoGenT-Global-Will-Pilot-Collaborative-Review-Of-Gene-Therapies EMA To Become Observer Of FDA’s Project Orbis Early This Year: https://pink.citeline.com/PS149579/EMA-To-Become-Observer-Of-FDAs-Project-Orbis-Early-This-Year New Year’s Predictions From FDA Leadership Past And Present: GLP-1s, Mental Health, Big Data: https://pink.citeline.com/PS149583/New-Years-Predictions-From-FDA-Leadership-Past-And-Present-GLP1s-Mental-Health-Big-Data US FDA’s Role In Artificial Intelligence/Machine Learning Development Is ‘Convener,’ Califf Says: https://pink.citeline.com/PS149608/US-FDAs-Role-In-Artificial-IntelligenceMachine-Learning-Development-Is-Convener-Califf-Says

Building A Biotech: Exploring ILC’s Hybrid Interferon Platform

Thu, 11 Jan 2024 13:39:41 -0000

In the latest episode of the In Vivo podcast, non-executive chair Peter Bains and Owain Millington, vice president of immunology and head of preclinical, discuss ILC Therapeutics’ platform technology, financing plans as well as the pros and cons of running a startup biotech in the UK.

전 세계 비만 치료제 임상시험 건 수, 미국이 가장 높아…한국은 9위 (Korean-language podcast)

Thu, 11 Jan 2024 00:12:59 -0000

Join Jung Won Shin for this Korean-language mini podcast talking about a report from Citeline's Datamonitor Healthcare. Datamonitor Healthcare의 비만치료제시장 분석리포트를 요약한 내용입니다. https://www.biomedtracker.com/reportdetail.cfm?reportid=863

Scrip's Five Must-Know Things - 10 January 2024

Wed, 10 Jan 2024 02:13:50 -0000

Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: 2023 drug launch highlights; the M&A outlook for the new year; AstraZeneca’s China cell therapy acquisition; the pre-Christmas deal flow; and India at a turning point for ADCs? https://scrip.citeline.com/SC149606/Quick-Listen-Scrips-Five-MustKnow-Things

Podcast: Current trends in the biotech landscape with Chris Smyth, President, ICON Biotech Solutions

Tue, 09 Jan 2024 12:07:35 -0000

Listen as Chris Smyth, President, ICON Biotech Solutions discusses current trends in the biotech landscape, and predictions for future innovation, regulation and globalisation in this space. Recorded on Wednesday 15th November.

China Biotech Podcast - January 2024 (Chinese-language)

Tue, 09 Jan 2024 07:53:00 -0000

One week into 2024, there have already been multiple deals between Chinese innovative drug developers and multinational and the significant acquisition of GracellBio by AstraZeneca. Brian Yang and Dexter Yan invite guest speaker Liu Liu to discuss reasons behind the particularly active deal-making scene in the China biotech sector. https://scrip.citeline.com/SC149598/Chinese-Language-Podcast--AZMNC2024

Cardio Conversations: AVS Cracks Calcium With Novel Pressure Wave Balloon

Fri, 05 Jan 2024 20:30:18 -0000

In this edition of Cardio Conversations, Medtech Insight editor Reed Miller talked to Robert Chisena, the co-founder and CTO of AVS. He talked about the company's novel interventional technology for calcified peripheral arterial disease and how the company came together during the pandemic. Further Reading https://medtech.citeline.com/MT148128/Shockwave-Begins-First-All-Female-Study-Of-Coronary-Interventions https://medtech.citeline.com/MT147704/Reimbursement-For-Shockwaves-IVL-Device-May-Pose-Quandary-For-CMS https://medtech.citeline.com/MT147623/Abbott-Buys-CSI-To-Add-Peripheral-And-Coronary-Atherectomy-Technologies https://medtech.citeline.com/MT147548/Shockwave-Buys-Neovasc-Hoping-Reducer-Angina-Device-Complements-Coronary-Lithotripsy https://medtech.citeline.com/MT143510/FDA-Approves-Shockwave-Coronary-Intravascular-Lithotripsy-System Further Listening The full recording of this podcast, as well as all of our other Citeline podcasts, are available on Apple Podcasts, Google Podcasts, SoundCloud, TuneIn, Spotify Podcasts and via smart speakers if one of these platforms has been set up as your default podcast provider.

Drug Fix: Looking Back And Looking Ahead: Key US and EU Legislation

Fri, 05 Jan 2024 17:19:24 -0000

Pink Sheet reporter and editors discuss key US and EU legislation that impacted 2023 and how it also could affect 2024, including EU legislative reform (:56), US Medicare drug price negotiations (14:43), and the US Food and Drug Administration user fee reauthorization (30:57). More On These Topics From The Pink Sheet European Commission Explains Impact Of EU Pharma Review On SMEs & Non-Profit Entities: https://pink.citeline.com/PS149505/European-Commission-Explains-Impact-Of-EU-Pharma-Review-On-SMEs--NonProfit-Entities Biopharma’s Prospects Under A Second Trump Term: They Can’t Get Much Worse: https://pink.citeline.com/PS149562/Biopharmas-Prospects-Under-A-Second-Trump-Term-They-Cant-Get-Much-Worse The following special topic pages include links to all of our coverage: EU Legislative Reform: https://pink.citeline.com/eu-legislative-reform FDA User Fees: https://pink.citeline.com/us-fda-user-fees Drug Pricing Debate: https://pink.citeline.com/pricing-debate

Unlock the Future of Cancer Detection with Dr Charles P. Vega, MD, FAAFP: Listen Now!

Wed, 03 Jan 2024 17:06:29 -0000

Join us for an insightful Q&A session with Dr. Vega, where we delve into the groundbreaking world of Multi-Cancer Early Detection (MCED) and the future of cancer detection.

The Challenges of Rare Neurological Disease Drug Development

Fri, 22 Dec 2023 22:50:19 -0000

In this episode, In Vivo speaks to Bruce Leuchter, CEO of Neurvati Neurosciences, about ways clinical drug development in rare neurologic diseases is being held back and what can be done to make the process more efficient and successful.

【3分で解説世界のファーマ】第15回治験に被験者の「多様性」を米国の課題 (Japanese-language podcast)

Fri, 22 Dec 2023 02:53:33 -0000

世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。今回取り上げた記事はこちら「Clinical Trial Diversity Plans: Early Oncology Experience Shows More Work Needed, US FDA Says（邦題意訳：FDA、被験者の多様性を義務化へ　がん治験では課題も）」 https://pink.citeline.com/PS149444/Clinical-Trial-Diversity-Plans-Early-Oncology-Experience-Shows-More-Work-Needed-US-FDA-Says 世界の薬事規制ニュースPink Sheet（ピンクシート）とは？ https://www.citeline.com/ja-jp/products-services/regulatory-and-compliance/pink-sheet

Medtech Connect Episode 11: A Look Back At 2023

Wed, 20 Dec 2023 19:52:23 -0000

In this episode, Medtech Insight regulatory reporter Hannah Daniel speaks to King & Spalding’s Eric Henry about the year’s most influential digital health regulations in the US and EU, and what we may have missed in all the excitement.

Biopharma’s Must-Know 2023-4 Catalysts

Wed, 20 Dec 2023 11:46:45 -0000

In this podcast Scrip looks at the some upcoming clinical catalysts for biopharma, judged by the size of the sales forecasts at stake. Companies including Sanofi, Cytokinetics, Corcept and Inventiva stand to gain – or lose.

Scrip’s Five Must-Know Things – 19 December 2023

Tue, 19 Dec 2023 06:04:15 -0000

Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: first ever gene editing FDA nod; US FTC ruffles pharma’s feathers; AstraZeneca pays to play in RSV; Syndax leukemia drug makes splash at ASH; BMS bets big on Chinese ADC. https://scrip.citeline.com/SC149527/Quick-Listen-Scrips-Five-MustKnow-Things

Drug Fix: Taking A Look Back, And Forward, With US FDA’s Project Orbis

Fri, 15 Dec 2023 17:40:22 -0000

Pink Sheet reporters and editors in the US and Europe consider the growth and impact of Project Orbis after a year in which two major regulators joined the program, but several countries did not keep up with the US approval pace. More On These Topics From The Pink Sheet Project Orbis 2023: FDA Approves Six New Cancer Drugs, But Partner Nations Lag Behind: https://pink.citeline.com/PS149452/Project-Orbis-2023-FDA-Approves-Six-New-Cancer-Drugs-But-Partner-Nations-Lag-Behind Project Orbis: More Cancer Drugs Available In Scotland Than England: https://pink.citeline.com/PS149063/Project-Orbis-More-Cancer-Drugs-Available-In-Scotland-Than-England EMA Will Observe Project Orbis In Effort To Increase Collaboration: https://pink.citeline.com/PS148458/EMA-Will-Observe-Project-Orbis-In-Effort-To-Increase-Collaboration US FDA Eyes Project Orbis-Type Approach For Cell And Gene Therapies: https://pink.citeline.com/PS147730/US-FDA-Eyes-Project-Orbis-Type-Approach-For-Cell-And-Gene-Therapies

China Biotech Podcast - December 2023 (Chinese-language)

Thu, 14 Dec 2023 05:45:04 -0000

Brian Yang and Dexter Yan discuss Biokin/BMS's ADC deal, WuXi Biologics' share price drop, BlissBio's recent developments and Pfizer's divestment of Prevenar 13 commercial rights in China to a Chinese local partner. https://scrip.citeline.com/SC149497/Chinese-Language-Podcast-BiokinBMS-Deal-Developments-At-Pfizer-BlissBio-WuXi-Biologics

Scrip’s Five Must-Know Things – 11 December 2023

Mon, 11 Dec 2023 05:58:27 -0000

Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: another acquisition for AbbVie; Roche buys into the obesity market; J&J’s oral immunology push; oral incretins advance; and AstraZeneca on Chinese innovation. https://scrip.citeline.com/SC149480/Quick-Listen-Scrips-Five-MustKnow-Things

Over the Counter 7 Dec 2023: IFRA On Potential Impact Of EU's CLP Revision

Thu, 07 Dec 2023 17:28:35 -0000

In this episode, HBW Insight speaks to Aurélie Perrichet, regional director, Europe at the International Fragrance Association. We discussed the implications of planned revisions to the European Commission’s Classification, Labeling and Packaging (CLP) regulation, which may re-categorize biological materials as mixtures, from their current status as substances. Perrichet also speculated how the proposed change could reduce the number of available essential oils and other types of fragrance and flavor materials available.

제약업계의 생성형AI 적용 성공의 열쇠는? (Korean-language podcast)

Tue, 05 Dec 2023 00:25:30 -0000

최근 제프리스 헬스케어 컨퍼런스에서 발표된 제약바이오산업의 생성형인공지능 적용사례에 대한 Scrip 기사를 요약한 내용입니다. https://scrip.citeline.com/SC149412/As-Biopharma-Adopts-Generative-AI-The-People-Element-Is-Crucial-To-Success

Scrip's Five Must-Know Things - 4 December 2023

Mon, 04 Dec 2023 04:27:39 -0000

Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: CAR-Ts and malignancies; comeback for GSK’s Blenrep?; Novartis’s pipeline cull; FGF21 analogs in NASH; and a call to action from the Scrip Awards Lifetime Achievement winner. https://scrip.citeline.com/SC149443/Quick-Listen-Scrips-Five-MustKnow-Things

Drug Fix: CAR-T Malignancy Reports, Background Music In DTC Ads, New No. 2 At US FDA

Fri, 01 Dec 2023 18:03:08 -0000

Pink Sheet reporter and editors discuss the FDA acknowledging reports of malignancies in patients who received CAR-T cell immunotherapies (:35), the agency’s policy for using background music in direct-to-consumer advertising (7:27), and the FDA’s new incoming principal deputy commissioner (13:44). More On These Topics From The Pink Sheet CAR-T Malignancy Reports Could Temper Excitement For Use Beyond Oncology: https://pink.citeline.com/PS149420/CAR-T-Malignancy-Reports-Could-Temper-Excitement-For-Use-Beyond-Oncology Background Music During Risk Segment Of Rx Drug Ads: FDA Explains Its Policy: https://pink.citeline.com/PS149411/Background-Music-During-Risk-Segment-Of-Rx-Drug-Ads-FDA-Explains-Its-Policy US FDA Chief Scientist Bumpus Will Become Principal Deputy Commissioner: https://pink.citeline.com/PS149428/US-FDA-Chief-Scientist-Bumpus-Will-Become-Principal-Deputy-Commissioner

RNA And Kidneys And Diagnostics RNA, Oh My – Discussing Verici DX’s Differentiated Product Offering

Mon, 27 Nov 2023 16:45:23 -0000

In this podcast, In Vivo speaks to Sara Barrington, CEO of Verici DX. During the discussion, Barrington outlines the current challenges facing patients post-transplant, why current diagnostics are inadequate, and where the overall transplant market is headed, considering the rise of home dialysis and the potential future for xenotransplants.

Scrip’s Five Must-Know Things – 27 November 2023

Mon, 27 Nov 2023 03:57:12 -0000

Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: Bayer’s Phase III failure; US group seeks Japan changes; AstraZeneca winning AKT race for now; NASH developments at AASLD; and the Q3 impact of China’s corruption campaign. https://scrip.citeline.com/SC149413/Quick-Listen-Scrips-Five-MustKnow-Things

Trends In Epidemiology

Thu, 23 Nov 2023 13:49:55 -0000

Datamonitor Healthcare’s Epidemiology team (Ridwaan Ibrahim, Lucia Rodriguez-Garcia, Maya Trivedy, and Asma Ali) discuss the current trends in epidemiology throughout the world, and how epidemiology data is being used to support drug discovery and improve health outcomes. Topics discussed include epidemiology methodologies, Alzheimer’s Disease, non-communicable diseases in Africa, genetic epidemiology, pollution, and increasing cancer rates. Other platforms Apple Podcasts -   https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836 Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU1NDkyOC9zb3VuZHMucnNz TuneIn - https://tunein.com/podcasts/Business--Economics-Podcasts/Pharma-Intelligence-Podcasts-p1140128/ Spotify Podcasts - https://open.spotify.com/show/3DTc3eIh4xI6pVOd6DdO67

Scrip Lifetime Achievement Award 2023: Jeremy Levin’s Acceptance Speech

Wed, 22 Nov 2023 17:45:41 -0000

In accepting Scrip’s Lifetime Achievement Award, Ovid Therapeutics’ CEO called on pharma to show responsible leadership and live up to its potential to do good for society.

China Biotech Podcast (Chinese language) - November 2023

Tue, 21 Nov 2023 14:20:22 -0000

Brian Yang and Dexter Yan discuss the FDA approval of Chinese PD-1, Sanofi BioMap AI deal, Third quarter earnings and Biden-Xi Summit and US-China regulatory dialogue.

Discussing The Potentials Of And Challenges For Digital Therapeutics

Tue, 21 Nov 2023 09:18:15 -0000

In this podcast, Medtech Insight speaks to Andy Molnar, CEO of the digital therapeutics alliance; Joel Morse, CEO and co-founder of Curavit and Owen McCarthy, CEO and co-founder of MedRhythyms. The trio discuss the current situation surrounding digital therapeutics, and where they believe they are headed in the coming years.

Digital Health Roundup: Black Friday Hits – Digital Twins, Biowearables, Robotics, Cardiology

Tue, 21 Nov 2023 03:27:00 -0000

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights interviews with Abbott’s head of Lingo Biowearables and top executives at Twin Health. Reed Miller provides an update on J&J MedTech’s launch of the Ottava soft-tissue robotic surgery system and Barnaby Pickering talks about his recent interview with Leo Grady, former CEO of Paige AI, to talk about his new start-up Jona. Medtech Insight articles addressing topics discussed in this episode: Can Digital Twin Technology Help Beat Chronic Disease? Twin Health Is Getting Users Hooked, And Off Their Meds https://medtech.citeline.com/MT148407/Can-Digital-Twin-Technology-Help-Beat-Chronic-Disease-Twin-Health-Is-Getting-Users-Hooked-And-Off-Their-Meds Abbott’s Metabolic Biowearable Gets ‘Extremely Positive’ UK Reception; Next Up, US Filing https://medtech.citeline.com/MT148365/Abbotts-Metabolic-Biowearable-Gets-Extremely-Positive-UK-Reception-Next-Up-US-Filing After Two-Year Delay, J&J Plans To Start Trial Ottava Surgical Robot In 2024 https://medtech.citeline.com/MT148422/After-TwoYear-Delay-JJ-Plans-To-Start-Trial-Ottava-Surgical-Robot-In-2024 Leo Grady’s Jona Hopes To Repair Microbiome Testing’s Murky Reputation https://medtech.citeline.com/MT148403/Leo-Gradys-Jona-Hopes-To-Repair-Microbiome-Testings-Murky-Reputation Investing In Digital: Slow And Steady May Win This Race https://invivo.citeline.com/IV148596/Investing-In-Digital-Slow-And-Steady-May-Win-This-Race

Scrip’s Five Must-Know Things – 20 November 2023

Mon, 20 Nov 2023 09:02:28 -0000

Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: AstraZeneca CEO on obesity and more; biotech’s rollercoaster ride set to continue; new Wegovy data; Novo’s plans for semaglutide in NASH; and Zepbound set to become biggest drug ever? https://scrip.citeline.com/SC149388/Quick-Listen-Scrips-Five-MustKnow-Things

Drug Fix: Janet Woodcock retiring, Accelerated Approval Reform, US FDA Meeting Recording Policy

Fri, 17 Nov 2023 18:59:54 -0000

Pink Sheet reporters and editors discuss US FDA Principal Deputy Commissioner Janet Woodcock’s legacy as her retirement approaches (:42), the stance of the FDA’s oncology division on confirming benefit after an accelerated approval (16:59), and why formal meetings between the agency and sponsors cannot be recorded (36:51). More On These Topics From The Pink Sheet With Woodcock’s Retirement, US FDA Loses A Renaissance Woman: https://pink.citeline.com/PS149368/With-Woodcocks-Retirement-US-FDA-Loses-A-Renaissance-Woman Confirmatory Trial Plan For Acrotech’s Folotyn, Beleodaq Needs Rethinking, FDA Panel Says: https://pink.citeline.com/PS149361/Confirmatory-Trial-Plan-For-Acrotechs-Folotyn-Beleodaq-Needs-Rethinking-FDA-Panel-Says FDA Panel To Consider Strategies For Timely Completion Of Accelerated Approval Confirmatory Trials: https://pink.citeline.com/PS149353/FDA-Panel-To-Consider-Strategies-For-Timely-Completion-Of-Accelerated-Approval-Confirmatory-Trials Accelerated Approval: US FDA Writing Guidance On What ‘Ongoing’ Means For Confirmatory Trials: https://pink.citeline.com/PS149359/Accelerated-Approval-US-FDA-Writing-Guidance-On-What-Ongoing-Means-For-Confirmatory-Trials Accelerated Approval: Acrotech’s Confirmatory Trial For Folotyn, Beleodaq More Than A Decade Behind Schedule: https://pink.citeline.com/PS149342/Accelerated-Approval-Acrotechs-Confirmatory-Trial-For-Folotyn-Beleodaq-More-Than-A-Decade-Behind-Schedule Minutes Matter: Why The US FDA Refuses To Record Formal Meetings: https://pink.citeline.com/PS149310/Minutes-Matter-Why-The-US-FDA-Refuses-To-Record-Formal-Meetings

Citeline Podcasts

PD-(L)1/VEGF双抗赛道——中国可否率先改写一线肺癌标准治疗？(Chinese-language podcast)

Scrip M&A Podcast with Cooley Attorneys Kevin Cooper and Bill Roegge.

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast) Apr. 21, 2026

Scrip's Five Must-Know Things - Apr. 21, 2026

The Generics Bulletin Podcast: Green Regulations With Medicines for Europe’s Adrian van den Hoven

Drug Fix: CBER Director Candidate Emerges, US FDA Promotes Leucovorin Pathway

성숙기 진입 중인 ADC 시장…삼성바이오에피스, 차별화 전략 강화 (Korean-language podcast) Apr. 17, 2026

Japan Q1 Roundup: Key Commercial and Policy/Regulatory Developments

Lilly TuneLab: Breaking Data Silos in Biotech with Federated Learning

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast) Apr. 10, 2026

Scrip's Five Must-Know Things - Apr. 13, 2026

Drug Fix: Leucovorin’s Resurrection, PhRMA’s Leadership Change

No Matter What: How Israel Is Positioning Itself as a Global Pharma Innovation Hub

Inside Step Pharma’s Pan‑Cancer Ambition

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast) Apr. 6, 2026

Scrip's Five Must-Know Things - Apr. 6, 2026

China Biopharma English-Language Podcast: China’s Regulatory Changes In Cell Therapy

Five-Minute Podcast: “UK Needs To Align More With The EU”

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast) Mar. 30, 2026

Why Longevity Is The Next Big OTC Opportunity, With Euromonitor’s Magda Starula

Scrip's Five Must-Know Things - Mar.30, 2026

Drug Fix: US FDA Commissioner Martin Makary Completes First Year In Charge

Lupin’s CEO And MD On GLP-1 Strategy, Business Growth And Legacy

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast) Mar.23, 2026

Scrip's Five Must-Know Things - Mar.23, 2026

Drug Fix: ACIP Next Steps After Judge Stops Work, Potential Opioid Disposal Changes

How a CDMO Created a Custom Vaccine Development Project

뇌질환 신약 개발 펀딩 부활 조짐 (Korean-language podcast) Mar.19, 2026

The Generics Bulletin Podcast: 2026 Conferences

Winning In The Probiotics Space, With David Pineda Ereño

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast) Mar.16, 2026

Scrip's Five Must-Know Things - Mar.16, 2026

Drug Fix: US FDA’s Prasad Leaves, Harry Potter, And Is CNPV Effective Because Of RTOR?

Killing Cancer Loudly: Onchilles Pharma's Neutrophil-Derived Path to Pan-Cancer Therapy

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast) Mar.9, 2026

Scrip's Five Must-Know Things - Mar.9, 2026

Drug Fix: The State Of Facility Inspections With Two Former Senior US FDA Execs

Unpacking Europe’s Probiotic Rules with David Pineda Ereño

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast) Mar. 2, 2026

Scrip's Five Must-Know Things - Mar.2, 2026

Drug Fix: State Of The Generics Industry, US FDA Commissioner On Compassionate Use

Affibody and the Case for Antibody Mimetics in Radioligand Therapy

글로벌 제약업계, 2026년 역풍 직면…최혜국 약가정책 영향은 제한적 (Korean-language podcast) Feb.25, 2026

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast) Feb. 24, 2026

Scrip's Five Must-Know Things - Feb.24, 2026

Drug Fix: ‘America First’ US FDA User Fees, Moderna’s Flu Vaccine Saga Continues

Hansa Biopharma On Clearing The Path To Kidney Transplant

ESG, Eco‑Pricing and Sustainable Packaging, with Steve Ramus

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast) Feb. 16, 2026

Scrip's Five Must-Know Things - Feb.16, 2026

Drug Fix: US FDA Versus Moderna And The Changing Role Of Refuse To File Actions

Preventing Lung Disease in Preterm Babies

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast) Feb. 9 , 2026

Scrip's Five Must-Know Things - Feb. 9, 2026

Drug Fix: US FDA Hiring Improves, But Can The Agency Avoid Oversight Erosion?

Navigating A Changing EU And US Sustainability Landscape, With Steve Ramus

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast) Feb.2, 2026

Scrip's Five Must-Know Things - Feb. 2, 2026

Drug Fix: Understanding US FDA’s CNPV Application Reviews

How Senti Bio's Programmable Cell Therapy Tackles AML's Toxicity Problem

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast) Jan.26, 2026

Scrip's Five Must-Know Things - Jan. 26, 2026

Scrip JPM Podcast: Dealmaking, Regulatory And Commercial Expectations For 2026

Drug Fix: US FDA Review Speed Steady In 2025, But Will Staffing Impact In 2026?

Herantis’s ‘Elegant’ Approach In Parkinson’s

【3分で解説 #世界のファーマ】第28回 ノバルティスが警鐘 自国第一主義の弊害へ (Japanese-language podcast)

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast) Jan.19, 2026

Scrip's Five Must-Know Things - Jan. 19, 2026

Drug Fix: Pazdur’s CNPV Problems, Could US FDA Release Unapproved Product Action Packages?

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast) Jan.13, 2026

Scrip이 묻다: 2026년 바이오의약품 업계 전망은? 자본배분과 딜메이킹 (Korean-language podcast)

Scrip's Five Must-Know Things - Jan. 13, 2026

Drug Fix: Oncology Stalwart Richard Pazdur Leaves US FDA

Building a Nasal First line of Defense Against H5N1

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast)

Scrip's Five Must-Know Things - Dec. 22, 2025

“We Are On The Cusp Of A Real Revolution”: OHC Rare Disease Center Boosts Innovation

Scrip Awards Podcast, 2025 Winners

Datamonitor Healthcare Podcast: A Deep Dive into Dry AMD

【3分で解説 #世界のファーマ】第28回ノバルティスが警鐘自国第一主義の弊害へ (Japanese-language podcast)

【3分で解説 #世界のファーマ】第27回中国バイオ企業の成長 5つのテーマ (Japanese-language podcast)

3分で解説 #世界のファーマ】第26回欧州の先発医薬品米国関税15％適用へ (Japanese-language podcast) Sept.24, 2025