Recon: US to complete its exit from WHO; Janux, BMS enter $850M deal to develop solid tumor therapy
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Senior CDC official: Loss of measles elimination status in US would be ‘cost of doing business’ (STAT)
- The number of new drug shortages in U.S. hits lowest level in 20 years, but myriad problems remain (STAT)
- As FDA raises bar in rare diseases, pivotal moment nears for RegenxBio (STAT)
- Vaccine makers feel a chill as Kennedy's rhetoric becomes reality (Reuters)
- FDA Moves to Tighten Food Label Rules to Warn About Gluten (Bloomberg) (HHS) (Federal Register)
- FDA clears Aidoc tool to detect 14 different conditions from a CT scan (STAT)
- U.S. makes exit from the WHO complete (STAT) (Reuters)
- China-rooted Corxel raises up to $287M for GLP-1 pill with global ambitions (Endpoints)
- Is Europe raising its drug prices? Depends who you ask (Endpoints)
- Hua Medicine plots diabetes drug expansion in China and beyond (Endpoints)
- Greater Involvement Of The European Medicines Agency Could Refocus Devices Sector (MedTech Insight)
- EU Faces Tariff & Trade Deal Woes As Mercosur And US Deals Paused (Pink Sheet)
- Guinea-Bissau says plans for controversial U.S.-funded vaccine study need further review (STAT)
- Janux Therapeutics, Bristol Myers enter up to $850 million deal to develop cancer drug (Reuters) (Endpoints)
- Amicus reveals it had another suitor before reaching $4.8B sale to BioMarin (STAT)
- Corcept's drug extends patients' lives in key ovarian cancer study (Endpoints)
- BioMarin vets spearhead new biotech with $82M for rare disease drugs (Endpoints)
- Moderna curbing investments in vaccine trials due to US backlash, CEO tells Bloomberg TV (Reuters)
- Many patients may keep off lost pounds after stopping a GLP-1, US data suggests (Reuters)
- Merck unit partners with global health coalition to develop affordable Ebola vaccine (Reuters)
- India's Alivus Lifesciences posts higher third-quarter profit on API boost (Reuters)
- AdvaMed leaders on tariffs, MDUFA and wearables (MedTech Dive)
- Abbott posts Q4 sales below expectations (MedTech Dive)
- ECRI names misuse of AI chatbots as top health tech hazard for 2026 (MedTech Dive)
- J&J’s cardiovascular business boosts medtech growth in 2025 (MedTech Dive)
- Abbott Wins CE Mark For Dual-Ablation Catheter In Increasingly Competitive AFib Ablation Market (MedTech Insight)
- Multiple Injuries, Deaths Linked To Boston Scientific Axios Stent And Delivery System (MedTech Insight)
- What RFK Jr.’s milk mustache says about the historic power of dairy in the U.S. (STAT)
- Recalled tuna accidently shipped to stores in 9 states: How to know if your cans are impacted (The Hill)
- Alabama hospital system would gain monopoly with proposed $450 million deal (STAT)
- A Goldilocks approach to centralization of high-risk pathogen research (STAT)
- Top CDC vaccine adviser questions need for polio shot, other longstanding recommendations (STAT)
- Anthony Letai says NCI is more stable than perceived and is heading for a big year (STAT)
- Health insurance CEOs head to DC (Endpoints)
- After Push To Expand ‘Real-Time’ Application Review Beyond Oncology, STAR Gets No Takers (Pink Sheet)
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