In this week's Digital Health Roundup, MedTech Insight's Shubham Singh explores how Ketryx's launch of validated AI agents could reshape compliance automation in medtech. Marion Webb highlights news from BCI makers Synchron, Axoft and Subsense. Elizabeth Orr discusses AI advances at the FDA.

Digital Health Roundup: Synchron Syncs With Apple, Ketryx’s AI Agents, AdvaMed’s AI RoadMap

Summer Colling speaks with Emma Wille about the symptoms, diagnosis, and treatment landscape of Sjögren’s disease, highlighting the latest research and developments.

A Deep Dive into Sjögren's Disease

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss why seemingly routine comments from Vinay Prasad, director of the US Food and Drug Administration’s Center for Biologics Evaluation and Research, that he would stay away from daily review decisions were notable (:26), as well as the impact of proposed FDA budget cuts by the White House and the House of Representatives (17:16).

More On These Topics From The Pink Sheet

Prasad Says Involvement In US FDA Product Approvals Will Mirror Prior CBER Directors: https://insights.citeline.com/pink-sheet/rare-diseases/prasad-says-involvement-in-us-fda-product-approvals-will-mirror-prior-cber-directors-KF4LJWX5U5DLBMSM6D4YFL7ZOA/ 

To Compete With China, US FDA Must Deregulate Early Gene Therapy Studies, CAR-T Inventor Says: https://insights.citeline.com/pink-sheet/advanced-technologies/cell-and-gene-therapies/to-compete-with-china-us-fda-must-deregulate-early-gene-therapy-studies-car-t-inventor-says-VDVXZGZIJZFHHNGGQXYILBI7RM/ 

FDA’s FY 2026 Budget Request Lacks New Policy Proposals: https://insights.citeline.com/pink-sheet/legislation/fdas-fy-2026-budget-request-lacks-new-policy-proposals-WV3LE2AYBRAC7LIYJEU4WZDNGU/ 

User Fee-Funded Staff Would Drop In FY 2026 US FDA Budget: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/user-fee-funded-staff-would-drop-in-fy-2026-us-fda-budget-TQZMEB57V5GELNPMYGTY5BEGOY/ 

House Gives US FDA More Non-User Fee Funds Than Requested: https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/house-gives-us-fda-more-non-user-fee-funds-than-requested-PCQZCBHOB5ARPICMJJQ6VYIJ5M/

Drug Fix: Prasad Staying Out Of Application Reviews, US FDA Proposed Budget Cuts

Audio roundup of selected biopharma industry content from Scrip over the business week ended 6 June 2025. In this episode: Sanofi’s Blueprint buy; AstraZeneca’s breast cancer resistance results at ASCO; BMS and BioNTech’s big bispecific deal; Kymera’s Dupixent in a pill; and Degron’s CEO on pipeline and strategy. 
https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-T5ID4HF465BXFGAH7C6OOSEGTA/

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 - 9 June 2025

In this first episode of the series, small biotech companies are facing tough times, shrinking funding and uncertain futures. But beneath the surface, quiet forces of innovation and resilience are rising. We explore how these sparks of hope might just light the way to a new breakthrough.

First Sparks: Falling for Innovation in a Harsh Market

The 14 July entry deadline for the Citeline Japan Awards 2025 in Tokyo on 21 October is fast approaching! Join Ian Haydock and Lisa Takagi in this bilingual mini podcast as they outline the event and the various Award categories. (Japanese starts at 2:20.)  

More information on categories, entry criteria, table bookings and sponsorship opportunities here: 
English: https://www.citeline.com/en/awards/citelinejapanawards)
Japanese: https://www.citeline.com/ja-jp/awards/citelinejapanawards)

Citeline Japan Awards 2025 - Entry Deadline Approaching! (Bilingual English/Japanese)

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Francesca Bruce, Senior Editor Cathy Kelly and Editor-in-Chief Nielsen Hobbs consider European officials’ opinions of President Trump’s Most Favored Nation drug pricing proposal (:29), the uncertainty the plan has created and could create for the pharmaceutical industry (22:48), as well as its potential impact on the both sides of the Atlantic Ocean (27:42).

More On These Topics From The Pink Sheet

‘Brainless’ US MFN Policy Could Drive Pharma Investment To Europe: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/brainless-us-mfn-policy-could-drive-pharma-investment-to-europe-Z3FC7WBPKNF2LLG4YVZK3RBDUA/ 

US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany: https://insights.citeline.com/pink-sheet/geography/europe/us-most-favored-nation-pricing-could-be-game-changer-for-drug-access-in-germany-XFXD72XUSBE7VNLRMRSRQQGU5Q/ 

US Most Favored Nations Policy: Higher Drug Spending In Germany Is ‘Difficult To Imagine’: https://insights.citeline.com/pink-sheet/geography/europe/us-most-favored-nations-policy-higher-drug-spending-in-germany-is-difficult-to-imagine-QYQGDAMNH5A3HK4YWHUYFJCWME/ 

Could EU Collective Procurement Counter US Most Favored Nation Policy?: https://insights.citeline.com/pink-sheet/could-eu-collective-procurement-counter-us-most-favored-nation-policy-WPQOHPWQ3NF55NYDKT5KMU7AEY/ 

US ‘Most Favored Nations’ Drug Pricing Policy Will Jeopardize Innovation In Europe: https://insights.citeline.com/pink-sheet/us-most-favored-nations-drug-pricing-policy-will-jeopardize-innovation-in-europe-TR52C5V6GVDSJBOTCEJ7T74FB4/ 

New Pricing Agreements And Greater Transparency: What A US MFN Policy Could Mean For France: https://insights.citeline.com/pink-sheet/risk-sharing-agreements-greater-transparency-in-pricing-what-us-most-favored-nations-policy-could-OYEHJIF6LJCQZDL6VJHATV77JA/ 

Crisis Or Opportunity? US MFN Policy Could Test Japan’s Appetite For Reforms: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/crisis-or-opportunity-us-mfn-policy-could-test-japans-appetite-for-reforms-3OTVRHXSOFFIJARSNHPWZ7SBJ4/ 

Drug Fix: The US and Ex-US Impact Of Most-Favored Nation Drug Pricing

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.

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