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/ 


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

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

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

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.

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

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. 

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

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

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

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

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

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

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

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.

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

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

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

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

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

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.

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

Citeline

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