Recon: FDA denies Atara’s cell therapy for rare transplant complication; Lilly CEO looks for ‘common cause’ with Trump administration
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Four pressing challenges facing Trump’s health regulators as AI makes deeper inroads into medicine (STAT)
- DEA unveils telehealth rules for Adderall, buprenorphine, other controlled medications (STAT)
- JPM Week rewind: M&A, mixed signals, and CEO chats (STAT)
- Medicare director, at JPM conference, gives tips on how to lead the nation’s largest payer (STAT)
- Eli Lilly is considering offering more Zepbound doses in vials at lower cost (STAT)
- Eli Lilly CEO says the company sees ‘significant common cause’ with Trump administration (STAT)
- Novartis enters fight against HHS for denying its 340B rebate model (Endpoints)
- Pharma digs in on changes it wants from Trump administration (Reuters)
- UnitedHealth Group CEO says complex US healthcare system needs to change (Reuters)
- FDA rejects Atara's cell therapy for rare transplant complication, stock craters (Endpoints)
- Novartis wins temporary pause to Entresto generic launch in US (Reuters)
- International monitor recommends end to monkey shipments from Cambodia (STAT)
- Denmark’s new manufacturing learning center; Telix buys facility, assets and tech from ImaginAb (Endpoints)
- WHO appeals for $1.5 billion for emergencies with US funding in question (Reuters)
- EU Pharma Reform & Reducing Reliance On Asian Imports: What To Expect in 2025 (Pink Sheet)
- EMA’s Conflict Of Interest Rules Must Not Limit Access To Experts And Risk Innovation, Warns Industry (Pink Sheet)
- UK’s MHRA To Offer Private Meetings For Innovative RWE Strategies (Pink Sheet)
- EU mulls retaliation after showing China’s bias against foreign device firms (MedTech Dive)
- Studies reveal a new biology of Huntington’s, renewing drugmaker interest in therapies (STAT)
- Editas, after slow start, outlines plan to catch other CRISPR companies (STAT)
- Could inhaling xenon gas help treat Alzheimer’s? A new mouse study suggests it might (STAT)
- Boehringer's schizophrenia asset fails Phase 3; GSK buys organoid biotech (Endpoints)
- A mixed year for deals and dollars left biotech execs hungry for a better 2025 (Endpoints)
- Intuitive CEO drills down on da Vinci 5 rollout, force feedback debate (MedTech Dive)
- Hologic receives FDA warning letter over Biozorb implantable markers (MedTech Dive)
- Dexcom CEO talks Stelo sensor launch, OTC strategy (MedTech Dive)
- Boston Scientific ups PFA forecast, targets market leadership (MedTech Dive)
- CMR Surgical makes interim CEO permanent (MedTech Dive)
- CES 2025 Roundup: AI-Powered Cameras Detect Asthma, COPD, Diabetes; Spit Reveals Stress Hormone Levels; Perimenopause Symptoms Revealed (MedTech Insight)
- Niche Innovator Deltex Medical On Market Access, EU MDR And A Mission To Change The World (MedTech Insight)
- Shredding the Medicaid safety net (STAT)
- The companies paying hospitals to hand over patient data to train AI (STAT)
- US FDA grants first market authorization of nicotine pouches to Zyn (Reuters)
- Is FDA Man’s Best Friend’s Best Friend? (FDA Law Blog)
- Exit Interview: US FDA’s Patrizia Cavazzoni Says CDER Staff In ‘Best Place Possible’ (Pink Sheet)
- Medicare Negotiated Drugs Can Face Immediate Generic, Biosimilar Substitution, CMS Proposal Confirms (Pink Sheet)
- Pugilistic Vanda Collects Another NOOH As US FDA Defends Tradipitant Turndown (Pink Sheet)
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