Farideh Bischoff, chief medical officer of Heranova Lifesciences, discusses the urgent need for better diagnostic options and the latest innovations transforming care for endometriosis patients.

Europe’s self-care industry leaders, policymakers and stakeholders are heading to Warsaw, Poland between the 4th and 6th June this year for the Association of the European Self-Care Industry’s 61st Annual Meeting.

With Poland heading up the EU Council and the country being one of the largest and most self-care friendly markets in Europe, the location made sense, explains AESGP director general Jurate Švarcaite, in this episode of Over the Counter.

As always, there’s a jam-packed line up for the event, which every year sets the agenda for industry in the months to come.

Highlights for Jurate include sessions on the role of prevention in self-care and the competitiveness of European industry on the world stage.

I’m personally also looking forward to discussions about how industry will square the circle of sustainability, with medicines posing unique challenges for both regulators and manufacturers.

Sign up for AESGP’s 61st Annual Meeting: https://aesgp.eu/events/61st-aesgp-annual-meeting

Audio roundup of selected biopharma industry content from Scrip over the business week ended 21 March 2025. In this episode: Pfizer tops pharma leaderboard; AstraZeneca buys into in vivo cell therapy; Almirall looks to dominate derma spectrum; Incyte’s HS contender looks approvable; and MSD’s Williams says pharma should shorten tech adoption cycles.

https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-EGD3MLOIVJDKRCE32KV376CJ5Q/

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 and Editor-in-Chief Nielsen Hobbs discuss industry stakeholders’ complaints about US Food and Drug Administration productivity declines in the weeks since President Trump took office and began making changes and the potential recourse for industry (:24). They also review the expected and emerging problems with the agency requiring nearly all of its Washington, D.C.-area staff to return to in-office work at its White Oak headquarters and consider its impact on workflow going forward (15:35).

More On These Topics From The Pink Sheet

US FDA’s Speed Of Work Under Trump Quietly Raising Industry Concerns: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-speed-of-work-under-trump-quietly-raising-industry-concerns-ZWM522FIDJAO7DVAJYZRLLDFAI/

US FDA Survives First Day Of Return To In-Office Work, But True Test Upcoming: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-survives-first-day-of-return-to-in-office-work-but-true-test-upcoming-AZOWC5ITNNGGVG3TIGGWR5VMBA/

Cramped Quarters, Limited Parking And Water Concerns Await US FDA’s Return To Office: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/cramped-quarters-limited-parking-and-water-concerns-await-us-fdas-return-to-office-YWHJRM6RTZF4NJP2MZX4Y6LLQA/

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.”