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March 11, 2025
by Jason Scott

Recon: BMS buys cell therapy partner 2seventy bio for $286M; Zydus buys majority stake in French device maker Amplitude

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US
  • Former NIH director Francis Collins, once beloved in Washington, now worries for his safety there (STAT)
  • Senators say Kennedy must disclose details on drugmaker connections (Bloomberg)
  • US FDA Would See Another Austere Year With GOP Funding Bill, No PRV Reauthorization (Pink Sheet)
  • GLP-1 Compounding: Court Backs US FDA Approach To Managing Drug Shortage List (Pink Sheet)
  • States eye mRNA vaccine limits for a hesitant public (Politico)
In Focus: International                                                                                                       
  • India's Zydus Lifesciences to buy 86% stake in French medical devices maker (Reuters)
  • Bayer share drop draws market regulator's scrutiny, source says (Reuters)
  • Japan PM Delays Revision Of High-Cost Healthcare Benefit After Patient Protests (Pink Sheet)
  • CDMO Almac continues expansion spree with new £65M UK oral treatment plant (Fierce Pharma)
  • Kenya HIV patients live in fear as US aid freeze strands drugs in warehouse (Reuters)
  • Countries, global health groups band together as US aid gaps threaten lives (Reuters)
  • WHO starts slimming down in response to US cuts, document shows (Reuters)
  • Nigeria steps up fight against Lassa fever outbreak after 98 deaths this year (Reuters)
Pharma & Biotech
  • Bristol Myers buys out cell therapy partner 2seventy bio (Endpoints)
  • Diseased protein degrader shows mixed results in breast cancer trial (STAT)
  • Arvinas, Pfizer’s PROTAC data fall short of hype in breast cancer (Endpoints)
  • Merck opens billion-dollar facility to make bladder cancer immunotherapy (Endpoints)
  • Virtual physical therapy startup Hinge Health files to go public (Endpoints)
  • Viking pays $150M to recruit CordenPharma for obesity drug manufacturing saga (Fierce Pharma)
  • Roche Absorbs $2.4B Impairment in Overhaul of Spark Gene Therapy Unit (BioSpace)
  • Opinion: FDA Faces Challenging Decision on Biomarker-Based Label Restrictions (BioSpace)
Medtech
  • New Flagship startup aims to trailblaze ‘AI science factories’ (Endpoints)
  • Douglas Kelly, deputy science director at FDA’s device center, leaves agency (MedTech Dive)
  • ECRI warns insufficient AI governance threatens patient safety (MedTech Dive)
  • HIMSS 2025: Interview with Aneesh Chopra, Arcadia’s Chief Strategy Officer, About The Future Of Health Data, Interoperability, AI (MedTech Insight)
  • European Health Data Space: Commission And Industry’s Key Principles And Priorities (MedTech Insight)
Government, Regulatory & Legal
  • Life sciences preprint servers have grown up — and are setting out on their own (STAT)
  • Five years of Covid exacted a terrible toll. Another epidemic has claimed even more lives (STAT)
  • Trump administration plans to restrict Obamacare enrollment period (Reuters)
  • EMA Calls For Accurate Data In CTIS To Improve Visibility On Clinical Trials Map (Pink Sheet)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
 
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
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