Recon: Califf defends FDA’s record on obesity, food in Senate hearing; UK to limit access to Lilly’s Mounjaro
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- US FDA cited animal lab at Musk’s Neuralink for ‘objectionable conditions’ (Reuters)
- Change Healthcare cyberattack drives 2024 into another record year for health data breaches (STAT)
- Moderna CEO defends pandemic prep efforts with critics set to enter Trump’s administration (Endpoints)
- US FDA Generic Drug Approvals, Other Actions Declined As Approval Times Climbed In FY 2024 (Pink Sheet)
- Novo Nordisk to cut US list prices of two insulin products by more than 70% (Reuters)
- Baxter resumes dialysis solution production at its hurricane-hit facility (Reuters)
- U.K. to restrict Eli Lilly’s obesity drug to patients with greatest need (STAT)
- AstraZeneca replaces benched exec in China (STAT)
- GSK extends Shingrix pact in China but for less money, adds RSV vaccine deal (Endpoints)
- Novo Nordisk budgets $409M for new quality control lab in Denmark (Endpoints)
- UK Proposes Simplified Consent Method For Low-Risk Trials (Pink Sheet)
- Nordic Countries Launch ‘English-Only’ Packaging Pilot To Tackle Medicine Shortages (Pink Sheet)
- Enhertu Among Drugs In Annual China NRDL Update (Pink Sheet)
- AstraZeneca chided by marketing watchdog after complainant aims allegations at senior staff (Fierce Pharma)
- Novavax scores $200M as it hands over keys to Czech production plant—along with 300 employees—to Novo Nordisk (Fierce Pharma)
- Cause of outbreak in DRC still being investigated, health officials say (STAT)
- Why Applied Therapeutics has a credibility problem (STAT)
- Atlas Venture completes ‘disciplined’ $450 million fundraise (STAT)
- GSK's third new pact of the week focuses on Alzheimer's with startup Muna Therapeutics (Endpoints)
- Pediatric COVID Shots, Still Under EUA, Would Be Vulnerable In Anti-Vax HHS (Pink Sheet)
- Beyond The REMS: Clozapine Adcomm Shows Why In-Program Assessments Are Not Always Enough (Pink Sheet)
- CG Oncology’s bladder cancer treatment shows durability potential in Phase 3 (Endpoints)
- Nuvig raises $161M as it prepares for Phase 2 study in hot autoimmune field (Endpoints)
- AstraZeneca scores FDA nod for Imfinzi as first immunotherapy for limited-stage small cell lung cancer (Fierce Pharma)
- Amgen rolls out $1B investment to build new drug substance plant in NC's biopharma hotbed (Fierce Pharma) (Reuters)
- Agenus to offer CDMO services, lay off staffers as part of latest reorganization (Fierce Pharma)
- AI scribes are mostly rescuing doctors from themselves (STAT)
- Haemonetics to offload whole-blood business for up to $67M (MedTech Dive)
- Medtronic And Tempus Are ALERT To Heart Valve Disease Health Disparities (MedTech Insight)
- FDA Provides LDT Registration 101 For Manufacturers (MedTech Insight)
- Full Speed Ahead: FDA Final Guidance Allows Swifter Deployment of Device AI (MedTech Insight)
- U.S. Patent Office pulls controversial rule to curb pharma patent abuse (STAT)
- Insulet wins $452 mln US verdict against EOFlow in insulin pump secrets case (Reuters)
- UnitedHealthcare CEO’s killing lays bare rising security risks facing health care leaders (STAT)
- What we know about the killing of UnitedHealthCare’s CEO (STAT)
- UnitedHealthcare CEO Brian Thompson became one of the country’s most powerful insurance execs before tragic killing (STAT)
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