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November 5, 2024
by Jason Scott

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)
In Focus: International                                                                                                       
  • 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)
Pharma & Biotech
  • 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)
Medtech
  • 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)
Government, Regulatory & Legal
  • 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)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.

A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
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