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December 15, 2025
by Jason Scott

Recon: Sanofi inks $1.7B deal with Dren Bio for autoimmune therapy; MHRA approves GSK’s twice-yearly asthma treatment

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • Trump order blocking state AI laws could slow health AI adoption, leave patients vulnerable (STAT)
  • AstraZeneca, Daiichi's breast cancer drug gets FDA nod as first-line treatment (Reuters)
  • Medicare routes $16 billion to insurers to offset high drug costs (STAT)
  • Gilead's experimental HIV treatment non-inferior to blockbuster drug in trial (Reuters)
  • Moderna Takes on Unusual FDA Request: Do Its Vaccines Cause Long Covid? (Bloomberg)
  • US FDA sends warning letters to Walmart, Target for selling recalled baby formula (Reuters)
  • US FDA grants priority voucher to J&J's blood cancer treatment (Reuters)
In Focus: International
  • Europe’s pharma policy shakeup moves forward toward enactment (STAT)
  • China has a cheap, quick and quiet way to test novel therapies. Western genetic medicine makers want in (Endpoints)
  • UK approves GSK's twice-yearly asthma drug (Reuters)
  • UK Doctors Plan Strike This Week After Rejecting Streeting Offer (Bloomberg)
  • Sanofi returns to Dren Bio for another B cell depletion therapy at $100M upfront (Endpoints)
Pharma & Biotech
  • Areteia Therapeutics, a $425M bet on asthma disorder, to wind down after terminating Phase 3 studies (Endpoints)
  • Adaptive signs deal with Pfizer worth up to $890 million for rheumatoid arthritis research (Reuters)
  • Kyverna to take autoimmune CAR-T to FDA after success in stiff person syndrome trial (Endpoints)
  • Aviceda's geographic atrophy drug fails mid-stage study. Can it do better in Phase 3? (Endpoints)
  • Palvella unwraps Phase 2 data for rapamycin gel in rare skin disease (Endpoints)
  • InnoCare says Zenas-partnered drug succeeds in China study in form of lupus (Endpoints)
  • Immunome's rare tumor drug passes Phase 3 test, could challenge Merck KGaA (Endpoints)
  • Sanofi flags second delay to FDA decision on multiple sclerosis drug, shares fall (Reuters)
  • Cencora to take majority control of cancer care network OneOncology for $5 billion (Reuters)
  • Fosun Plans to Buy Maker of Controversial Alzheimer’s Drug (Bloomberg)
  • OpenAI-Backed Chai Discovery Raises $130 Million for AI-Designed Molecules (Bloomberg)
  • Argenx Drops After Discontinuing Thyroid Eye Disease Drug Trial (Bloomberg)
  • Everything is changing in dementia diagnosis and treatment (STAT)
Medtech
  • Medical Supplier Medline Guides IPO to Upper Half of Price Range (Bloomberg)
  • FDA needs more staff, authority to oversee device recalls, watchdog finds (MedTech Dive)
  • AtriCure treats first patients with dual PFA/RF system (MedTech Dive)
  • Mick Farrell named chair of AdvaMed board (MedTech Dive)
  • All Change For Notified Bodies: Moving Towards A More Highly Regulated Future (MedTech Insight)
Food & Nutrition
  • As superbug fears grow, sales of antibiotics used in food-producing livestock rose dramatically last year (STAT)
  • Explainer: What is lumpy skin disease for cattle and why are French farmers angry? (Reuters)
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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