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)
- 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)
- 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)
- 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)
- France to Ban Food Imports Containing EU-Prohibited Pesticides (Bloomberg)
- Food makers cut prices to reignite growth (Food Dive)
- 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)
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
