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December 8, 2025
by Jason Scott

Recon: FDA misses PDUFA goal date for Agios' thalassemia therapy; Mirum to buy Bluejay for up to $820M

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • NIH shut out hundreds of young scientists from funding to start their own labs (STAT)
  • Driven by GLP-1s, prescription drug spending explodes at major health insurers (STAT)
  • FDA misses PDUFA review deadline for Agios' thalassemia drug (Endpoints)
  • Kennedy's advisers scrap hepatitis B vaccine guidance for most children in major policy shift (Reuters)
  • Why Bill Gates Thinks Donald Trump Cares About Global Health (Bloomberg)
In Focus: International
  • Congo battles worst cholera outbreak in 25 years, UNICEF says (Reuters)
  • Eli Lilly's Mounjaro added to China's state insurance list for diabetes treatment (Reuters)
  • Global leaders commit $1.9 billion to eradicate polio amid funding cuts (Reuters)
  • Chinese Biotech, Investments Are on Track to Face New US Curbs (Endpoints)
  • Carlyle Group Is Said to Lead Bidding for Japan’s Hogy Medical (Bloomberg)
  • NICE Rules-Based Pathway Tops Conference Talking Points For UK Healthtechs (MedTech Insight)
  • EU Targets Faster, Predictable Multinational Clinical Trial Reviews (Pink Sheet)
  • UK-US Trade Deal: How New Value Set For HTAs Will Impact UK Drug Pricing (Pink Sheet)
Pharma & Biotech
  • Mirum to buy Bluejay for up to $820 million in bet on liver-disease drug (Reuters) (Endpoints)
  • Kymera drug positioned to rival Sanofi and Regeneron’s Dupixent succeeds in early-stage eczema trial (STAT)
  • Merck outbid three competitors in $9.2B acquisition of Cidara (Endpoints)
  • Updated: Structure Therapeutics’ obesity pill stacks up with Novo and Lilly; Ascletis also reports early results (Endpoints)
  • BioNTech, OncoC4’s antibody more than halves risk of death in Phase 3 lung cancer trial (Endpoints)
  • Kura, Syndax detail data for rival menin inhibitors as both eye earlier use in AML (Endpoints)
  • Dyne says Duchenne drug succeeds in pivotal study, heads to FDA for approval (Endpoints)
  • Cogent’s mastocytosis drug continues momentum, helps treat sicker patients (Endpoints)
  • Recursion Pharma's AI-powered therapy reduces polyp growth in a rare disease trial (Reuters)
Medtech
  • My continuous glucose monitor graphs my life — but misses the big picture (STAT)
  • Freenome inks deals to list stock and raise $330M (MedTech Dive)
  • FDA advisory panel votes unanimously against J&J heart shunt (MedTech Dive)
  • Olympus-backed Swan EndoSurgical names Erik Todd as CEO (MedTech Dive)
  • Medtronic’s Hugo RAS Gets FDA Nod For Urologic Procedures, But Intuitive Still Leads, Analyst Says (MedTech Insight)
  • Olympus Hits Another Endoscope Snag, Updates Instructions For PolyLoop After 113 Serious Injuries (MedTech Insight)
  • CorWave Ready To Dive Into LVAD Market Following First-In-Human Study (MedTech Insight)
Food & Nutrition
  • White House to roll out $12 billion farm package (The Hill)
Government, Regulatory & Legal
  • Tylenol Maker Lacks Texas Business Registration, Judge Says (Bloomberg)
  • You Better Move Fast: ACCESS to TEMPO (FDA Law Blog)
  • HBV Is Only The Beginning: US CDC’s ACIP Targeting Vaccine Adjuvants Next (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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