AI in medtech is def interesting. Gonna be a game changer. Hope the updates make stuff safer and easier for all.

In this week’s Digital Health Roundup, Medtech Insight’s Marion Webb brings highlights from Deloitte’s 2025 Life Sciences Outlook Report with medtech leaders’ forecasting significant investments in AI/GenAI. Brian Bossetta talks about the US FDA’s newly formed Digital Health Advisory Committee. Elizabeth Orr highlights the pros and cons of penetration testing for cybersecurity and talks about the US FDA’s final guidance on pre-determined change control plans. Natasha Barrow highlights UK MHRA's AI Airlock Pilot program and MANIFEST.

Related Links:

https://insights.citeline.com/medtech-insight/pickleball-smart-homes-brain-games-caregiving-agetech-take-centerstage-at-aarps-ces-2025-presence-CIGK5RS7EVG2XH3XBQSUYDQXI4/

Digital Health Roundup: 2025 Will See More AI/GenAI Adoption In Medtech, FDA’s Digital Health Push

The consumer healthcare industry is changing. Companies are separating from their pharmaceutical parents and brands are shifting from therapeutic solutions to preventative health and wellness options. These shifts bring a number of challenges for OTC firms, notes AdverCheck managing director James Walmsley in the second part of his chat with HBW. For example, it is much more difficult to get science-backed claims for food supplements approved, he points out. With firms now also becoming standalone consumer health entities, there is no longer a direct pipeline of off-patent prescription medicines available for Rx-to-OTC switch, he observes. We may, therefore, see a new generation of switch-focused self-care companies and partnerships emerging.
Keywords: Innovation, AdverCheck, OTC medicines, Consumer Health, Rx-to-OTC switch
Timeline

The Challenge Of Innovating In A Changing OTC Industry With AdverCheck’s James Walmsley

트럼프의 관세 조치에 따른 미국시장 영향과 글로벌 빅파마들의 반응에 대한 Scrip 기사를 요약한 내용입니다.
https://insights.citeline.com/scrip/business/manufacturing/as-trumps-ups-the-ante-on-tariffs-reactions-are-mixed-7WMIGZ3O5JHF7AJSICVLRUE3GY/

Playlist: soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini

 

 

트럼프의 관세 인상에 대한 엇갈린 반응 (Korean-language podcast)

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

【3分で解説  世界のファーマ】第23回 トランプ関税 製薬への影響は (Japanese-language podcast)

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/ 


Drug Fix: What We Learned From US FDA Commissioner Nominee Makary’s Confirmation Hearing?

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. 

Grove AI and Grace, An Agentic AI For Clinical Trial Engagement

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.”

Women’s Health Innovation And Beyond, With Maxwellia’s Anna Maxwell

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

Scrip's Five Must-Know Things - 10 March 2025

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. 


Vaccines, Viruses & Variants: The State of COVID-19 & Flu in 2025

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.

Scrip M&A Podcast: Looking at M&A activity as Q1 2025 nears a close.

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. 

The Generics Bulletin Podcast: Stelara Biosimilar Launches In The US

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.

Digital Health Roundup: 2025 Will See More AI/GenAI Adoption In Medtech, FDA’s Digital Health Push

Citeline

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