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November 14, 2024
by Jason Scott

Recon: FDA raps Merz over misleading Instagram posts for wrinkle treatment; J&J sues Biden Administration over 340B drug payments

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

In Focus: US
  • FDA scolds Merz over ‘misleading’ Instagram posts featuring interior designer Nate Berkus (STAT)
  • Vertex’s upcoming sciatica trial readout is a high-stakes moment in its quest to quell pain (STAT)
  • Johnson & Johnson sues Biden administration over payment terms for 340B hospitals (STAT)
  • With GOP control of Congress, Trump has broad power to reshape health care (STAT)
  • Merck buys into PD-1/VEGF space as Summit comes for Keytruda (Endpoints)
  • Merck licenses Chinese cancer drug, searching for next Keytruda blockbuster (STAT)
 
In Focus: International                                                                                                                                
  • Changing course, European regulators now say Alzheimer’s treatment Leqembi should be approved (STAT)
  • BeiGene will rebrand to BeOne Medicines, dropping name's link to China roots (Endpoints)
  • New Zealand clears first clinical trial of epigenetic editing for hepatitis B (Endpoints)
  • Merck KGaA’s life science unit is still feeling the Covid demand decline (Endpoints)
  • EU Medtech Association Focuses On Innovation And Digital At 65th Anniversary (MedTech Insight)
  • La French Touch: How France Has Built a Reputation for Excellence In Medtech (MedTech Insight)
 
Pharma & Biotech
  • Novo Nordisk to phase out its production of human insulin pens globally (Endpoints)
  • Mild Alzheimer’s patients won’t save Cassava Sciences (STAT)
  • Neurogene and the race to the bottom of gene therapy (STAT)
  • As bluebird projects more commercial demand, the biotech continues to seek cash (Endpoints)
  • Zai Lab aims to raise $200M; Kronos Bio to seek ‘strategic’ options (Endpoints)
  • Exclusive: Ascidian CEO Michael Ehlers leaves Apple Tree Partners for MPM BioImpact (Endpoints)
  • GSK makes case for Blenrep's return with new blood cancer survival data (Endpoints)
 
Medtech
  • A telehealth friend in the new Congress, and Amazon’s smile on a mental health service (STAT)
  • Haemonetics to close California facility, lay off 75 people (MedTech Dive)
  • GE Healthcare’s head-only MRI scanner cleared by the FDA (MedTech Dive)
  • Dean Kamen, insulin pump pioneer, wants to shake up diabetes tech (MedTech Dive)
  • Livanova hits sleep apnea trial goals, plans FDA filing (MedTech Dive)
 
Government, Regulatory & Legal
  • FDA breakthrough device decisions rebound after recent declines (MedTech Dive)
  • Facing a dialogue with RFK Jr., a top FDA official mounts a public defense of vaccines (STAT)
  • Tech and social media bans alone cannot fix teen mental health (STAT)
 
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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