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March 18, 2025
by Jason Scott

Recon: Sarepta reports death of teen who received Duchenne gene therapy; Novartis to slash 427 jobs while revamping cardiovascular business

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

In Focus: US
  • 8 key players inside RFK Jr.’s HHS (STAT)
  • Walgreens Chair Pessina to boost stake after Sycamore seals takeover deal, FT reports (Reuters)
  • FDA’s return-to-office chaos, probationary workers reinstated, and demotion fears (Focus) (Endpoints)
  • Exclusive: Gates warns White House he can't fill shortfalls in US global health funding (Reuters)
  • Teenager who received Elevidys, Sarepta’s Duchenne gene therapy, dies (STAT)
  • Dr. Reddy’s, Sun Pharma and Zydus issue US recalls, citing failed specs and labeling issues (Fierce Pharma)
In Focus: International                                                                                                       
  • WHO issues starkest warning yet on fallout from U.S. withdrawal of aid for global health (STAT)
  • ‘No one can fill that gap’: Why a global health leader sees U.S. funding as irreplaceable (STAT)
  • Big pharma fears best-selling drugs in crosshairs of US-EU tariff spat (Reuters)
  • China encourages babymaking with free milk and childcare subsidies (Reuters)
  • Eight countries could run out of HIV treatments due to USAID cuts, WHO says (Reuters)
  • Saudi Arabia Expands Regulatory Role To Shape The Future Of Health And Longevity (MedTech Insight)
Pharma & Biotech
  • CRISPR company Arbor Biotechnologies gets cash infusion from ARCH (STAT)
  • Novartis to cut 400+ staffers in revamp of cardiovascular commercialization model (Endpoints)
  • George Church spinout developing genomically recoded organisms cuts most employees (Endpoints)
  • A Japanese biotech founded by Treg cell discoverer moves to the US with $45.8M (Endpoints)
  • Sofinnova Partners lands €165M, backed by big pharma, to build early-stage biotechs in Europe (Endpoints)
  • Mirador Pursues All Options To Be 2030’s Greatest I&I Breakthrough (BioSpace)
  • Taiho Pharmaceutical Buys ADC Partner Araris for up to $1.1B Total (BioSpace)
  • Klick buys Ward6 Singapore’s operations to fuel Asian expansion (Fierce Pharma)
  • Merck plots 163 layoffs as it prepares to shutter Pennsylvania manufacturing site (Fierce Pharma)
Medtech
  • Google to Expand AI Answers to Medical Queries in Search Results (Bloomberg)
  • 4 takeaways from AAOS 2025 (MedTech Dive)
  • Nuralogix Launches ‘Next-Generation’ MagicMirror With 4G Connectivity (MedTech Insight)
  • NHS England Abolition Fits UK Drive To Balance Regulation With Innovation (MedTech Insight)
Government, Regulatory & Legal
  • NIH cancels funding for landmark diabetes study at a time of focus on chronic disease (STAT)
  • Eric Green is out as head of National Human Genome Research Institute (STAT)
  • Private equity ‘gobbling’ up care facilities for people with disabilities (STAT)
  • Banning direct-to-consumer drug ads won’t work (STAT)
  • Congress created a unique plan to save rural hospitals — but few are using it (STAT)
  • Q&A: How one advocacy group is stepping in to bolster transgender data (STAT)
  • Top Insurance Chief to Head Back to School After Old Mutual Exit (Bloomberg)
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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