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October 8, 2024
by Jason Scott

Recon: GSK, Pfizer RSV vaccine sales drop in the US; Sage abandons Alzheimer’s drug after late-stage trial miss

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US
  • Harris seeks to tie expanded Medicare drug price negotiation to home care policy (STAT)
  • A pariah in science, the ‘CRISPR babies’ researcher gains support from a U.S. cryptocurrency entrepreneur (STAT)
  • White House should declare national emergency over IV fluid shortages caused by Helene, says hospital group (STAT)
  • Sage Therapeutics scraps Alzheimer’s drug development after trial fails; shares slide (Reuters)
  • Q&A: Why the NIH is spending $30 million to counter ableism in health care (STAT)
  • Compounding group sues FDA for removing Lilly’s obesity drug from its shortages list (STAT)
  • Pfizer's former top executives pitched changes to board as part of activist's plan (Endpoints)
  • GSK, Pfizer RSV vaccine sales fall in US as millions fewer people line up (Reuters)
  • GSK touts 3-year data on RSV shot Arexvy after CDC's narrower usage recommendation (Fierce Pharma)
  • Danco to seek FDA nod for use of abortion drug in miscarriages, WSJ reports (Reuters)
In Focus: International                                                                                                       
  • 12 people changing the course of the Chinese biopharma industry (STAT)
  • Eversana sets up shop in Germany with newest pharma commercialization services outpost (Fierce Pharma)
  • UK Gets Behind PIM Database Plan And Tools For Improved NHS Medtech Adoption (MedTech Insight)
  • EU's MDCG Releases Corrective And Preventive Action Plan Guidance For Notified Bodies (MedTech Insight)
  • UK’s Healthcare AI Gets A Boost From Regulatory Innovation Office (MedTech Insight)
  • Pfizer, BioNTech win bid to invalidate CureVac's UK COVID vaccine patents (Reuters)
  • Could US-Style Priority Review Vouchers Drive European Neglected Disease R&D? (Pink Sheet)
  • EU Pharma Reform: What You Need to Know Now (Pink Sheet)
  • India Tightens Oversight Of CROs With Mandatory Registration (Pink Sheet)
  • EU Launches Safety Review Of Finasteride And Dutasteride Over Suicidal Thoughts And Behavior (Pink Sheet)
Pharma & Biotech
  • Biotech veteran John Maraganore raises $135 million for his ‘next-generation RNAi’ startup (STAT)
  • Exclusive: A small San Diego biotech wants to change how Parkinson’s disease is diagnosed (Endpoints)
  • Biogen to seek approval for high-dose Spinraza after unveiling new data (Endpoints)
  • John Maraganore's RNAi biotech City Therapeutics debuts with $135M Series A (Endpoints)
  • Black Diamond cuts workforce, prioritizes lung cancer drug (Endpoints)
  • Afton Scientific eyes $200M plant expansion, 200 new jobs in Virginia (Fierce Pharma)
  • WeightWatchers to offer compounded version of Novo Nordisk's weight-loss drug (Reuters)
  • ‘There Is No Silver Bullet’ – Sandoz’s Haruvi Talks US Shortages (Pink Sheet)
Medtech
  • Exact Sciences wins FDA approval for improved stool-based colon cancer test (STAT)
  • Otsuka, Amalgam partner on Alzheimer’s care tech; Hello Heart joins Amwell’s telehealth network (STAT)
  • 2024 Nobel Prize winners: Physics award goes to Hopfield, Hinton for machine learning discoveries (STAT)
  • Biogen turns to telehealth company to boost its postpartum depression drug (STAT)
Government, Regulatory & Legal
  • Trump’s dangerous Covid-19 revisionism (STAT)
  • FTC’s New Commissioner ‘Dismayed’ By Agency Overreach (MedTech Insight)
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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