Citeline Podcasts

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: [email protected].

Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

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/

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.

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.

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.

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.”

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

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/

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

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.