Recon: Trump picks Makary to head FDA; FDA approves BridgeBio’s Attruby for rare heart condition
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Trump's FDA pick is surgeon and writer Martin Makary (Reuters) (STAT) (Axios) (Politico) (Endpoints) (NYTimes) (ABC News)
- What to make of Trump’s health care nominees (STAT)
- Trump’s pick to run FDA is top exec of company that provides compounded weight-loss drugs (STAT)
- Trump’s FDA director pick has a history of criticizing the agency. Here are seven examples (STAT)
- ‘We dodged a bullet’: Biotech and pharma react to selection of Marty Makary for FDA commissioner (STAT)
- Hims & Hers Shares Jump as Trump’s FDA Pick Seen as Major Ally (Bloomberg)
- Merck halts Phase 3 trial with PAH drug Winrevair following positive interim data (Endpoints) (Reuters)
- Thousands turn to Wegovy copies each month as FDA considers shortage status (Reuters)
- US FDA approves BridgeBio's drug for rare heart condition (Reuters)
- Japan Prices Kisunla Above Leqembi But May Cut In Future (Pink Sheet)
- European Commission Needs More Manpower To Drive Medtech Change (MedTech Insight)
- AZ's Truqap delivers phase 3 win in prostate cancer subtype after recent breast cancer miss (Fierce Pharma)
- EU CHMP Opinions And MAA Updates (Pink Sheet)
- Incyte touts Monjuvi data from Phase 3 follicular lymphoma trial as it heads to FDA (Endpoints)
- Cassava shares plunge as controversial Alzheimer’s drug fails Phase 3 trial (Endpoints) (Reuters)
- Gilead buys experimental HIV vaccines from a small Barcelona biotech (Endpoints)
- Biohaven's spinal muscular atrophy drug fails to meet study goal (Reuters) (Endpoints)
- Replimune aims to raise $125M; Otsuka makes another deal with Ionis (Endpoints)
- Pfizer led industrywide sales surge in Q3 after several quarters of dominance by Eli Lilly, Novo Nordisk (Fierce Pharma)
- Musk's Neuralink to launch feasibility trial with brain implant, robotic arm (Reuters)
- Boston Scientific to buy Intera Oncology, maker of liver cancer treatment (MedTech Dive)
- Medtronic, Tempus testing AI to find potential TAVR patients (MedTech Dive)
- Medtronic buys surgical instrument developer Fortimedix (MedTech Dive)
- FDA plan would alert public sooner on high-risk device recalls (MedTech Dive)
- Medtronic nets FDA nod for smart insulin pen app (MedTech Dive)
- Generative AI Devices The Focus Of First FDA Digital Health Advisory Committee Meeting (MedTech Insight)
- It’s a Three-Peat: DEA and HHS Extend Telemedicine Flexibilities Until December 31, 2025 (FDA Law Blog)
- Prognosis: Under Trump, the CDC is in big trouble, but the FDA might be OK (STAT)
- US Supreme Court rejects tobacco firms' appeal over graphic warnings (Reuters)
- Califf: Sponsors Should Go Beyond Letter Of Law With Trial Diversity Plans (Pink Sheet)
- Proposed Bill Would Grow Medicare Coverage For Breakthrough Devices (MedTech Insight)
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