Citeline Podcasts

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.

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.

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.

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.

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.

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

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

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/

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.

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

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

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/

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.

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

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