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)
- 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)
- 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)
- 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)
- 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)
- 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)
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