Recon: Walmart to settle opioid suits for $3.1B; Immunogen lands accelerated approval for ovarian cancer drug
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)
- 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)
- 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)
- 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)
- The FDA has banned certain vapes and medicines. We still bought these 13 products in its backyard (STAT)
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