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July 28, 2025
by Jason Scott

Recon: GSK pays $500M upfront to Hengrui for rights to several drugs; PE firms offer $3B to buy Bavarian Nordic

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

In Focus: US
  • New analysis predicts sprawling effects of proposed NIH budget cuts (STAT)
  • Trump targets supervised consumption of drugs and harm reduction in executive order (STAT)
  • Did a drug prevent this man’s ALS? (STAT)
  • FDA 'Expert Panels' Raise Concerns of Evading Regulations, Ethics (MedPage Today)
  • US Health, Tech Officials to Launch Data-Sharing Plan (Bloomberg)
  • FDA launches probe into new Elevidys death as Sarepta, Roche stress gene therapy not at fault (Fierce Pharma)
  • US health chief Kennedy targets vaccine injury compensation program (Reuters)
In Focus: International                                                                                                       
  • EU-US trade deal could add up to $19 billion in pharma industry costs, analysts say (Reuters)
  • European regulators endorse Lilly’s Alzheimer’s treatment for certain patients (STAT)
  • Europe moves to reject embattled Duchenne muscular dystrophy gene therapy (STAT)
  • Shanghai biotech VelaVigo snags $60M after landing two licensing deals (Endpoints)
  • Indian drugmaker Torrent Pharma's quarterly profit jumps on strong demand (Reuters)
  • NICE To Consult On UK Late-Stage Healthtech Assessments (MedTech Insight)
Pharma & Biotech
  • GSK pays $500M upfront for rights to series of Hengrui drugs (STAT)
  • Updated: Private equity firms eye $3B deal for vaccine maker Bavarian Nordic (Endpoints)
  • Roche to Test Whether New Drug Can Prevent Alzheimer’s (Bloomberg)
  • MapLight gets $372.5M for CNS pipeline in year's third-largest private round (Endpoints)
  • Recognify’s schizophrenia drug fails mid-stage test, backer atai’s stock dips (Endpoints)
  • Celcuity posts Phase 3 win in breast cancer, setting up challenge to Novartis and Roche (Endpoints)
  • Novo Nordisk faces 'show me' moment to boost Wegovy growth after US copycat ban (Reuters)
  • Celcuity's triple drug combo tops AstraZeneca's treatment in breast cancer trial (Reuters)
Medtech
  • Edwards loses longtime TAVR leader Larry Wood (MedTech Dive)
  • EU/US Trade Deal Raises Questions For Medtech (MedTech Insight)
  • Roche Diagnostics Growth Flattens As China Reforms Bite; Bets On US Manufacturing, CGM For Growth (MedTech Insight)
  • Award-Winning Lioness Implant Addresses ‘Silent Emergency’ Of Preterm Birth (MedTech Insight)
  • Boston Scientific Raises Outlook … Again: Headwinds Offset By EP And Watchman (MedTech Insight)
Food & Nutrition
  • Voluntary sustainable packaging goals are on the way out, Gartner says (Food Dive)
  • FDA looks to answer the question: What makes food ultra processed? (Food Dive)
Government, Regulatory & Legal  
  • Researchers sequence complex parts of human genome, expanding the future of precision medicine (STAT)
  • Hospitals boost their profit expectations for 2025 as health insurers stumble (STAT)
  • The lessons New York still has not learned from the Covid vaccine rollout (STAT)
  • UnitedHealth investors may seek roadmap on costs as Hemsley takes center stage (Reuters)
  • Medical group urges Kennedy not to fire US care task force (Reuters)
  • Oyez, Oyez, Oyez! Effective August 1, DEA Will Have No Administrative Law Judges (FDA Law Blog
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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