Recon: FDA extends review of Merus’ cancer drug; How Trump or Harris could affect healthcare policy
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- D.C. Diagnosis: Trump and Harris make their closing arguments on health care (STAT)
- The U.S. is at risk of losing the proteomics race to China (STAT)
- How a Kamala Harris presidency would change health care, from drug pricing to abortion (STAT)
- How a Donald Trump presidency would change health care, from Medicaid to chronic disease (STAT)
- A Q&A with the FDA’s top vaccine regulator amid a fresh wave of disinformation (STAT)
- The election is Tuesday. What’s at stake for the pharma industry? (Endpoints)
- Wall Street looking for CVS to show execution plan (Reuters)
- US FDA extends review of Merus' gene-targeting cancer therapy (Reuters)
- Canada approves GSK's RSV vaccine for adults aged 50 to 59 (Reuters)
- Sanofi reveals positive data for BTK inhibitor from $3.7B Principia takeover (Endpoints)
- Catalent misses Q1 revenue estimates ahead of $16.5 bln deal close with Novo Holdings (Reuters)
- The Global Wellness Industry Is Now Worth $6.3 Trillion (Bloomberg)
- 7 companies to watch in AI protein design (STAT)
- Early data from Arcellx, Gilead suggest CAR-T for multiple myeloma could offer safety benefit (STAT)
- Patient dies in Beam Therapeutics trial of CRISPR sickle cell treatment (STAT)
- Syndax inks a $350M royalty deal; FDA pushes back decision on Organon’s eczema drug (Endpoints)
- PrognomiQ raises $34M for lung cancer test (Endpoints)
- Nektar divests manufacturing site and reagent arm for $90M (Endpoints)
- Vertex makes money from sickle cell therapy Casgevy (Endpoints)
- Catalent misses Q1 revenue estimates ahead of $16.5 bln deal close with Novo Holdings (Reuters)
- Intra-Cellular's unstoppable Caplyta nails another trial, this time for relapse prevention in schizophrenia (Fierce Pharma)
- Medtronic, Recor win CMS transitional payment coverage for renal denervation devices (MedTech Dive)
- Integra Lifesciences names Mojdeh Poul as CEO (MedTech Dive)
- UK MHRA Plans Revised Device Roadmap By End Of 2024 (MedTech Insight)
- Why hospitals have been slow to adopt AI for medical care (Endpoints)
- Social media misinformation is scaring women about birth control (STAT)
- Advice For The Next US FDA Commissioner: Grow A ‘Thick Skin’ Against Political Pressure (Pink Sheet)
- Would Red or Blue Election Wins Be Better for PBMs? It’s a Tossup (Pink Sheet)
- IRA Litigation: Pharma’s Exit Options Irk Third Circuit Judges (Pink Sheet)
- From the Porcine to the Ridiculous to the Court of Appeals: Phibro’s Suit Against FDA Gets Muddy (FDA Law Blog)
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