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April 4, 2024
by Jason Scott

Recon: Amylyx withdraws ALS drug from US and Canada; Sanofi to settle 4,000 US Zantac cancer lawsuits

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

In Focus: US
  • Amylyx to pull ALS drug from market, cut 70% of staff (STAT)
  • Experts applaud Amylyx for keeping its promise to withdraw ALS drug Relyvrio after trial failure (Endpoints) (STAT)
  • For national security, the U.S. must maintain its biotech dominance (STAT)
  • Sanofi to settle 4,000 Zantac cancer lawsuits in US state courts (Reuters)
  • Costco offering members access to weight-loss programs including medication (Reuters)
  • Arbutus, Genevant gain an edge in COVID patent scrap with Moderna (Fierce Pharma)
In Focus: International
  • Mitsui and Rohto to buy $594 mln Chinese medicines company Eu Yan Sang (Reuters)
  • UK watchdog says Theramex-Viatris deal raises competition concerns (Reuters)
  • Drugmaker seeks approval for China's first biosimilar Ozempic (Reuters)
  • Fresh Opportunity For Free Scientific Advice For High-Risk Devices From EU Expert Panels (MedTech Insight)
  • Pharma Dubs EU HTA Proposal ‘Unworkable,’ But Patient Groups Support The Plan (Pink Sheet)
  • EU Produces Guide On 'Challenges' To NASH Drug Development (Pink Sheet)
  • China Implements Data Transfer Regulation, With Some Waivers (Pink Sheet)
  • Japan's PMDA To Open First Global Office, In D.C. (Pink Sheet)
Pharma & Biotech
  • How resurrecting extinct species might impact medicine (STAT)
  • What ‘de-extinction’ of woolly mammoths can teach us: a Q&A with evolutionary biologist Beth Shapiro (STAT)
  • Parkinson’s disease may be helped by GLP-1 drug, new study finds (STAT)
  • Exclusive: Ex-Recursion team launches Leash Bio, challenging AI field with its bet on needing more data (Endpoints)
  • eFFECTOR's lead lung cancer program falls through, stock crashes (Endpoints)
  • Candel’s promising Ph2 data in pancreatic cancer; Microbiome biotech raises £27M (Endpoints)
  • CureVac releases mixed interim Phase 2 data for seasonal flu vaccine (Endpoints)
  • Teva, forging ahead with new strategy, inks biosimilar deal with Spain's mAbxience (Fierce Pharma)
  • Apotex acquires specialty drugmaker Searchlight in expansion move (Fierce Pharma)
Medtech
  • DNA test that predicts opioid addiction should be pulled off the market, critics urge the FDA (STAT)
  • Why a Medtronic exec thinks a convergence of med tech and consumer tech is coming (Endpoints)
  • FTC asks Boston Scientific for more info on $3.7B Axonics deal (MedTech Dive)
  • Teleflex catheterization kit recall linked to 10 injuries, 1 death (MedTech Dive)
  • Eko wins FDA nod for AI to detect sign of heart failure using stethoscope (MedTech Dive)
  • QuidelOrtho pulls FDA submission of 4-virus test (MedTech Dive)
  • Thermo Fisher plots layoffs at California plasmid manufacturing site as demand swings (Fierce Pharma)
Government, Regulatory & Legal
  • Hospital care costs are out of control. Price caps can help (STAT)
  • As cyberattacks on healthcare persist, can the FDA’s new device regs hold up? (MedTech Dive)
  • Report Says VHA Needs Better Implant Tracking (MedTech Insight)
  • FDA Tells Congress What It Wants, What it Really Really Wants (FDA Law Blog)
  • Drug Cost-Sharing Limits Could Be Strengthened In Self-Insured, Large Group Plans In Upcoming Rule (Pink Sheet)
  • Obesity Drugs Cost Concerns Not Yet Impacting HHS Risk Adjustment Models (Pink Sheet)
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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