HBW Insight catches up with our own US Executive Editor, Malcolm Spicer, to find out all about Perrigo subsidiary HRA Pharma’s Rx-to-OTC switch of its daily contraceptive, Opill. Currently under consideration by the US Food and Drug Administration after a positive recommendation from its advisory committees, Spicer draws on 30+ years of writing about the US consumer healthcare market, as well as his extensive coverage of the subject, to tell us all we need to know about this historic switch.

What You Need To Know About HRA/Perrigo’s Historic US OTC Pill Switch With HBW’s Malcolm Spicer

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

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

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.

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

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/ 

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

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

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

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

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.

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

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/ 

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

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

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

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

Citeline places biopharma and medical device professionals, and those who focus on these industries, at the forefront of knowledge and insight, by providing the perfect combination of news and information together with penetrating insight and analysis. Citeline is a leader in the field of healthcare industry information.

What You Need To Know About HRA/Perrigo’s Historic US OTC Pill Switch With HBW’s Malcolm Spicer

Citeline

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