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March 24, 2025
by Jason Scott

Recon: Novo licenses Chinese biotech’s obesity candidate for up to $2B; 23andMe files for bankruptcy

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

In Focus: US
  • 23andMe filing for bankruptcy as CEO Anne Wojcicki resigns (STAT)
  • Novo Nordisk expands discounted Wegovy to all cash-paying US customers (Reuters)
  • Trump to nominate Susan Monarez for CDC director, elevating from acting role, sources say (CBS)
  • US CDC Vaccines AdComm Rescheduled For April Without Influenza Vote (Pink Sheet)
  • UBS Hires RBC Capital Biotech Bankers in US Health-Care Push (Bloomberg)
  • Alnylam jumps as expanded US approval for heart disease drug fuels growth prospects (Reuters)
In Focus: International                                                                                                       
  • Novo licenses Chinese biotech's obesity drug candidate for up to $2 billion (Reuters)
  • UK detects first case of bird flu in a sheep, stoking fears of spread (Reuters)
  • Brazil's Hypera to launch an Ozempic generic in 2026, CEO says (Reuters)
  • WHO calls for immediate action as report shows 10% rise in child TB infections in European region (Reuters)
  • European regulators to review GSK's asthma drug Nucala to treat COPD (Reuters)
  • Liver cancer drug combo gets second FDA rejection over manufacturing issues (Endpoints)
  • EU Project Aims To Boost Drug Testing Reliability By Replacing Monkeys With Pigs (Pink Sheet)
  • German Medtechs Up The Stakes On Amending Hospital Reform Law (MedTech Insight)
Pharma & Biotech
  • Philanthropy can help create a healthier biotech ecosystem (STAT)
  • Biogen plans to open new headquarters in Boston area in 2028 (Endpoints)
  • Tempero Bio, led by ex-Novartis execs, gets $70M to reduce substance use disorders (Endpoints)
  • Belgian biotech Augustine gets $85M for neuro and cardiometabolic pills (Endpoints)
  • SV Health Investors nabs $250M to fund dementia-focused biotechs (Endpoints)
  • Novartis' Fabhalta nod in C3G leaves room for rival Apellis (Fierce Pharma)
Medtech
  • Why HCA is ‘all in’ on surgical robotics (MedTech Dive)
  • J&J boosts planned US manufacturing investment to $55B (MedTech Dive)
  • Smiths Medical recalls port implants, warns on endotracheal tubes (MedTech Dive)
  • FDA posts early alert after Calyxo urinary stone device tied to death (MedTech Dive)
  • European Medicine Agency’s CHMP Qualifies First AI Tool For Use In Clinical Trials (MedTech Insight)
  • Barcelona’s S2 Xpeed Accelerates Hardware-Based Medtech Start-Ups From Prototype To Market (MedTech Insight)
  • Urgent Call for Leadership In EU Medtech To Steer Through Regulatory Challenges (MedTech Insight)
Food & Nutrition
  • Trump admin delays traceability rule to contain foodborne illness outbreaks (Food Dive)
  • US turns to Brazil for eggs and considers other sources during bird flu outbreak (Reuters)
  • Researchers Explore How Biases Affect Food Safety Management Systems, Suggest Supply Chain-Wide Culture Focus (Food Safety)
  • Researchers Explore AI Analysis of WGS Data for Foodborne Illness Source Attribution (Food Safety)
  • Canadian Chicken Study Finds Resistance to Important Antibiotics in Salmonella, Campylobacter (Food Safety)
Government, Regulatory & Legal
  • Five years ago, early career researchers needed help to survive the pandemic. Now they need it again (STAT)
  • Lawmakers are pushing the HALT Fentanyl Act as the solution to the overdose crisis. Experts warn it will fall short (STAT)
  • Cancer research, long protected, feels ‘devastating’ effects under Trump (STAT)
  • Calley Means joins White House as a special government employee, will assist with MAHA policies (Endpoints)
  • Testosterone, TRAVERSE, And A Label Change 15 Years In The Making (Pink Sheet)
  • No ACNU Yet; Effective Date Delayed Again (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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