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5 January 2026
by Jason Scott

Recon: Novo Nordisk launches Wegovy pill in US; Sanofi claims FDA will review diabetes drug age range

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • What does Neuralink want — to help people with paralysis, or prepare for a war with AI? (STAT)
  • NIH begins review of thousands of delayed research proposals, funding 135 on first day (STAT)
  • Novo launches Wegovy weight-loss pill for sale in US (Reuters)
  • Sanofi Says FDA Agrees to Review Diabetes Drug Age Range (The Wall Street Journal)
  • Time’s up: Enhanced ACA subsidies expire (MedTech Dive)
  • EPA urged to classify abortion drugs as pollutants (The Hill)
  • Health care, funding and more: 5 things to watch when the Senate returns (The Hill)
In Focus: International
  • A biotech incubator in China tries to unlock innovation — alongside drugmakers worldwide (STAT)
  • UK's pharma regulator could issue a decision for Novo's Wegovy pill by year-end (Reuters)
  • MHRA welcomes Professor Jacob George as he starts Chief Medical and Scientific Officer role (MHRA)
  • EU CHMP Opinions And MAA Updates (Pink Sheet)
  • Originator & Biosimilar Natalizumab Win English Funding For Highly Active MS (Pink Sheet)
Pharma & Biotech
  • US FDA declines to approve Outlook's eye disease drug for second time in 2025 (Reuters)
  • US FDA declines to approve Corcept's drug for rare hormonal disorder (Reuters)
  • US FDA approves Vanda Pharmaceuticals' motion sickness drug (Reuters)
  • US FDA approves Omeros' drug to treat dangerous transplant complication (Reuters)
  • Argenx CEO to step down in May, be succeeded by COO (STAT)
  • Ultragenyx shares plunge as bone disease drug fails to reduce fracture rate (Reuters)
  • Novo Nordisk's US public affairs head leaves company, memo shows (Reuters)
  • 3 issues to watch in biopharma in 2026 (STAT)
  • The biotech scorecard for the first quarter: 26 stock-moving events to watch (STAT)
  • Sanofi doubles down on Earendil in $160M near-term deal in search for bispecifics (Endpoints)
  • Zenas BioPharma’s Phase 3 autoimmune disease readout falls short, sending shares plummeting (Endpoints)
  • Moderna seeks flu vaccine approvals; Neumora Alzheimer's data (Endpoints)
  • Aktis Oncology eyes $181M listing to start industry’s anticipated IPO rebound (Endpoints)
  • Exclusive: Comanche collects $40M to take preeclampsia siRNA onto global stage (Endpoints)
  • Incyte's blood cancer therapy slows disease progression in trial (Reuters)
  • MPM BioImpact-backed Aktis Oncology seeks up to $840 million valuation in US IPO (Reuters)
Medtech
  • New medical technology presents hospitals with a prisoner’s dilemma (STAT)
  • Finger-Prick Blood Test Could Offer Easier Way to Detect Alzheimer’s, Researchers Say (Bloomberg)
  • Heading Off Tantrums Before They Start With the Help of a Smartwatch (Bloomberg)
  • Meet 5 medtech companies redefining surgical robotics (MedTech Dive)
  • New Henry Schein CEO expected by mid-January as Bergman extends tenure (MedTech Dive)
  • Medtech Ends 2025 At Strategic Crossroads As AI Matures, IPO Windows Reopen And M&A Re-Accelerates (MedTech Insight)
Food & Nutrition
  • France to Ban Food Imports Containing EU-Prohibited Pesticides (Bloomberg)
  • Food makers cut prices to reignite growth (Food Dive)
Government, Regulatory & Legal
  • MFN Drug Pricing Update: After GENEROUS, GUARD AND GLOBE Issue From CMS’s Innovation Center – Part I (FDA Law Blog)
  • Missed first vaccines make babies far more likely to miss measles shot, study finds (STAT)
  • Who will pay for AI in health care? 3 trends to watch in 2026 (STAT)
  • US abortion pill access under fire: Lawsuits and regulatory battles to watch in 2026 (Reuters)
  • HHS escalates Minnesota fraud fight, prompting fear among day care providers (The Hill)
  • Ex-Cheney physician says Trump aspirin regimen ‘makes no sense’ (The Hill)
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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