Recon: Walmart to settle opioid suits for $3.1B; Immunogen lands accelerated approval for ovarian cancer drug

ReconRecon | 15 November 2022 |  By 

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • Walmart to Pay $3.1 Billion to Settle Opioid Lawsuits (WSJ)
  • AEYE Health gets FDA approval to screen diabetics to prevent blindness (Reuters)
  • Immunogen's $6,220 ovarian cancer drug to be shipped within days (Reuters) (STAT) (FDA)
  • U.S. FDA staff flags unclear benefits of Ardelyx's kidney disease drug (Reuters)
  • FDA warns of rise in reports of child poisonings linked to cough medicine (NBC)
  • AbbVie agrees to pay $54.4 mln in antitrust case over Alzheimer's drug (Reuters)
  • Frustrations Grow Over Company’s Response to Breathing Device Recalls (NYTimes)
In Focus: International
  • Big pharma not doing enough to improve drug access – analysis (Reuters) (STAT)
  • Looming obesity drug rivalry not a concern for Novo CEO (Reuters)
  • Indonesia leader says intellectual property waiver must be widened on health issues (Reuters)
  • Australia recommends against fifth vaccine dose as fresh COVID wave builds (Reuters)
  • Japan's Daiichi Sankyo says mRNA COVID vaccine successful in booster trial (Reuters)
  • ‘A very worrying scenario’: Internal documents on India Covid-19 vaccine raise troubling questions about approval process (STAT)
Pharma & Biotech
  • Arcutis Biotherapeutics' skin disease cream meets main goal in late-stage study (Reuters)
  • US FDA Collects ‘Majority’ Of PDUFA Program Fees After Payment Plea (Pink Sheet)
  • Novo Nordisk, GSK pause some Twitter ad spending after Musk takeover (Endpoints)
  • Adamis, Harpoon, Neoleukin and Tricida add to biotech layoff wave as pipeline setbacks spur cuts (Fierce)
  • Horizon doubles down on Krystexxa marketing to physicians with ‘green stuff’ imagery (Endpoints)
  • Sellas retunes leukemia trial as patients live longer than expected. Is the biotech's drug behind survival boost? (Fierce)
  • GSK's antibiotics strategy scores 2nd win this month with phase 2 TB data (Fierce)
  • The crew that sold its lead IL-2 program to Roche is back with $93M to work on more next-gen I/O drugs (Endpoints)
  • Can an oncolytic virus therapy challenge the standard of care in bladder cancer? CG Oncology has $120M to find out (Endpoints)
  • Roche doubles down on Jnana's drug discovery platform, kicking off second deal with $50M cash — while biotech bags $107M (Endpoints)
Medtech
  • Illumina cuts workforce by 5% amid supply chain woes, sales slowdown (MedtechDive)
  • FDA Official Lists Four Regulatory Considerations For Connected Combination Products (MedtechInsight)
  • Pear Therapeutics undergoes another round of layoffs, cutting 22% of staff (MedtechDive)
  • ResMed, Google sibling Verily form digital health venture to improve access to sleep treatment (MedtechDive)
  • UK Has ‘Much Room For Improvement’ On Genomic Testing Access (MedtechInsight)
Government, Regulatory & Legal
  • The FDA has banned certain vapes and medicines. We still bought these 13 products in its backyard (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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