Citeline Podcasts

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

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

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/

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.

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

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/

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.

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

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.

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