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

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
「EFPIA Rallies EU To Shield Innovative Drugs After US Tariff Cap Is Confirmed（邦訳：欧州製薬団体、医薬品への米国関税適用に反発　EUへ対策を要請）」
URL:　 https://insights.citeline.com/pink-sheet/compliance/manufacturing/efpia-rallies-eu-to-shield-innovative-drugs-after-us-tariff-cap-is-confirmed-HYZJDK4S7NGT3FUEBA5AFSYYT4/

Playlist: soundcloud.com/citelinesounds/sets/japanese-language-mini

3分で解説  #世界のファーマ】第26回 欧州の先発医薬品 米国関税15％適用へ (Japanese-language podcast) Sept.24, 2025

Generics Bulletin editor Dave Wallace talks to John Murphy III, president and CEO of the US Association for Accessible Medicines, about the association's latest annual savings report and key topics affecting the US off-patent market.

The Generics Bulletin Podcast: Talking with AAM president and CEO John Murphy

Audio roundup of selected biopharma industry content from Scrip over the business week ended September 26, 2025. In this episode: Pfizer jumps back into obesity with Metsera bid; Roche maps out its obesity ambitions; UniQure’s encouraging gene therapy results for Huntington’s; BMS plans US pricing for Cobenfy in the UK; and vaccine skepticism affects vaccine commercial prospects.  
https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-HCVAK32IGREDHMH5D4I3RFY6AA/

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 - Sept. 30, 2025

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2025年9月26日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。

本期要闻：辉瑞通过收购Metsera重返肥胖治疗领域；罗氏勾勒肥胖治疗战略蓝图；UniQure公司亨廷顿病基因疗法取得积极进展；百时美施贵宝计划在英国采用美国定价策略推广Cobenfy；疫苗质疑情绪影响商业化前景。
https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-HCVAK32IGREDHMH5D4I3RFY6AA/

Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast) Sept.30, 2025

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, and senior editors Sue Sutter and Cathy Kelly consider the impact of the government shutdown on the US Food and Drug Administration, as well as industry (:21), and discuss the future of drug pricing after Pfizer completes its deal with the White House to embrace its Most Favored Nation plan (10:29). 

More On These Topics From The Pink Sheet

Shutdown Approaches: US FDA Would Retain Most Of Recently Trimmed Staff: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/shutdown-approaches-us-fda-would-retain-most-of-recently-trimmed-staff-DTVAHLBI5VGZBPHD76TLNDIBGU/ 

Shutdown Day One: US FDA Hiring, MFN Demos Delayed?: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/shutdown-day-one-us-fda-hiring-mfn-demos-delayed-7LGCITF2WVCJNEVUTWZV5MOZSE/ 

Closing The Gap? Pfizer Will Set Same US, Foreign Launch Prices In MFN Deal: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/closing-the-gap-pfizer-will-set-same-us-foreign-launch-prices-in-mfn-deal-ZRSNU56KTFGRBBX4Y5OJKLFV6Y/ 

Questions Persist About How Pfizer’s US Agreement Lowers Prices: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/questions-persist-about-how-pfizers-us-agreement-lowers-prices-T2TEWMKVMVHGJHPXDKIFDF2GWA/

Drug Fix: Government Shutdown’s Impact On US FDA, Pfizer Inks Drug Pricing Deal

Audio roundup of selected biopharma industry content from Scrip over the business week ended October 3, 2025. In this episode: Pfizer’s backroom US pricing deal; confusion over Japan’s pharma tariffs; more direct-to-patient schemes in the US; first approval for Novartis’s remibrutinib; and GSK’s CEO to step down. 
Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-NYTAMV4KPFCB3PSCCQMKIF2CEA/

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 - Oct. 6, 2025

Celebrating Europe’s Consumer Health Best Practice, With AESGP’s Luis Rhodes Baiao
The Association of the European Self-Care Industry, or AESGP, has launched a digital platform that brings together inspiring self-care initiatives from across Europe. Launched to coincide with International Self-Care Day 2025, AESGP’s Self-Care Insight and Inspire platform showcases national-level initiatives led or supported by the consumer health industry in collaboration with healthcare professionals, sectoral associations, and public authorities. In this episode of the Over the Counter podcast, AESGP governmental and public affairs manager, Luis Rhodes Baiao, tells HBW Insight about the background behind the platform and pulls out some of his favourite examples.
Timestamps
2:00 – Introductions
5:15 – AESGP’s Self-Care Insight and Inspire platform
14:30 – Luis’s favourite examples
17:30 – Public reaction to the campaign
18:50 – Next steps
20:30 – How to get involved
Guest Bio
Luis Rhodes Baiao is governmental and public affairs Manager at AESGP. Before, he was policy advisor to a Portuguese Member of the European Parliament on the Committee for Environment, Public Health and Food Safety (ENVI), during the mandate 2014 to 2019. He is currently also vice-president of the General Assembly of the Association Public Affairs Portugal (PAPT).

Celebrating Europe’s Consumer Health Best Practice, With AESGP’s Luis Rhodes Baiao

本期播客内容来自《Scrip》杂志，精选内容涵盖截至2025年10月3日当周的生物制药行业的商业动态。本期节目采用人工智能文本转语音及语音仿真技术制作。
本次要闻: 辉瑞暗箱操作美国定价协议；日本药品关税政策引发争议；美国直供患者计划持续扩张；诺华瑞美布替尼获首次批准；葛兰素史克首席执行官即将卸任。
https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-NYTAMV4KPFCB3PSCCQMKIF2CEA/

Playlist: on.soundcloud.com/gnr7PaOwflNKiAO7QX

Scrip 五件必知要闻: 药闻周析 - 全球制药风云聚焦 (Chinese-language podcast) Oct.7, 2025

Listen now as Citeline speaks with top executives from Perceptive to understand eClinical’s major reset and what it means for the future of clinical trials. Learn more about IRT’s evolving role, lessons learned, and how tech will rule the data-driven trials of the future. 

Defining the Next Era of Disruption

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.