Recon: FDA delays on AstraZeneca’s experimental breast cancer therapy; Abbott earns CE mark for dual glucose-ketone sensor
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- Trump’s drug-pricing deals set to be tested by new product launches (STAT)
- CVS brings back coverage for Lilly's obesity drug Zepbound (Reuters)
- US FDA extends review of AstraZeneca’s experimental breast cancer pill (Reuters)
- US HHS finalizes rule to streamline dispute resolution under No Surprises Act (Reuters)
In Focus: International
- Exclusive: China gene editing startup YolTech raises $70M to move CRISPR therapies forward (Endpoints)
- Cornerstone earns Europe’s CE mark for surgical robot (MedTech Dive)
- Abbott receives CE mark for dual glucose-ketone sensor (MedTech Dive)
- EU Digital Negotiations Heading In Wrong Direction, Medtech Sector Says (MedTech Insight)
Pharma & Biotech
- Experimental hepatitis B treatment was a ‘functional cure’ for nearly 1 in 5, new data show (STAT)
- Kailera’s own ‘triple-G’ drug also looks very powerful (STAT)
- After leaving Legend, founding scientist Frank Fan is ready to showcase his next project (Endpoints)
- Charles River CEO says it likely won’t be the last manufacturer to break away from cell and gene therapy (Endpoints)
- Viridian, awaiting FDA decision, taps WuXi Bio in eye drug supply deal (Fierce Pharma)
- With Elahere building steam, AbbVie nets FDA nod for another ImmunoGen cancer asset (Fierce Pharma)
Medtech
- Insulet recalls 7M patch pumps due to leak risk (MedTech Dive)
- J&J’s DePuy Synthes inks deal to buy orthopedic surgery tech (MedTech Dive)
- Another FDA Alert For Abiomed As J&J Defends Safety Record (MedTech Insight)
- Dexcom warns of scrapped glucose sensors being resold (MedTech Dive)
- Heart patch engineered from stem cells revved up weakened hearts (STAT)
- Particulate Matter In Fluid Path Prompts Class I Recall Of Medline Namic Manifolds (MedTech Insight)
Food & Nutrition
- How the food and beverage industry is rethinking manufacturing investments (Food Dive)
- FDA reopens investigation into Salmonella outbreak traced to moringa capsules (Food Safety News)
Government, Regulatory & Legal
- How Stanford patients help expose ‘fault lines’ in health AI adoption (STAT)
- US court overturns Insulet's $452 mln insulin-pump trade secret verdict against EOFlow (Reuters)
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.
