Recon: Biogen reports mixed results for Alzheimer’s tau drug; AstraZeneca to license Dizal’s lung cancer drug
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- Inside RFK Jr.’s push to dismantle decades of U.S. vaccine policy (Reuters)
- FDA approves at-home starter dose of Eisai-Biogen Alzheimer's drug (Reuters)
- Questions linger over Biogen's tau drug for Alzheimer's, as low dose reports better results (Endpoints) (Reuter)
- US to block citizens in Congo from immediate travel home, citing Ebola (Reuters)
- US appeals court revives hundreds of private lawsuits linking Tylenol to autism (Reuters)
- FDA Flags Medtronic Harmony Catheter Recall As Class I Over Tip Detachment (MedTech Insight)
- Only Two Generic Drug Makers At Administration’s Essential Medicine Production Meeting (Pink Sheet)
In Focus: International
- Congo begins trial of Gilead's experimental antiviral for Ebola Bundibugyo (Reuters)
- WHO says it has less than half funding needed to fight Ebola (Reuters)
- UK Wasted £10 Billion on Covid Gear in Pandemic, Review Finds (Bloomberg)
- AstraZeneca to license lung cancer drug from China's Dizal Pharmaceutical (Reuters)
- Spero licenses Innovent's experimental immune disease drug for up to $1.1 billion (Reuters)
- HistoSonics wins Europe’s CE mark for histotripsy system (MedTech Dive)
- New UK Clinical Trial Transparency Rules Prompt Patent Strategy Rethink (Pink Sheet)
- Pharma Industry Slams New Health Reforms In Germany That ‘Undermine’ Innovation And Investment (Pink Sheet)
Pharma & Biotech
- A breakthrough in pancreatic cancer has experts excited — and braced for what’s to come (STAT)
- Drug metabolism AI competition results show that bigger may not always be better (STAT)
- Chai Discovery gets $400M, tripling valuation from seven months ago (Endpoints)
- Draig nets $65M to advance depression drug aimed at rebuilding synapses (Endpoints)
- Exclusive: Genetic medicine startup launches to speed programs that stalled at Editas, Biogen (Endpoints)
- Cellares' recent wins have opened the floodgates for the IDMO (Fierce Pharma)
Medtech
- Edwards will pay $10M to settle FTC charges of skirting antitrust review (MedTech Dive)
- A Pump Under Pressure: Fresenius Kabi’s Ivenix Keeps FDA Busy (MedTech Insight)
- Alzheimer’s Blood Tests Equally Accurate In Primary, Secondary Care: Study (MedTech Insight)
- Freenome colorectal cancer test data improve on earlier results (MedTech Dive)
Food & Nutrition
- Michigan Points to Salad Greens as Potential Source of Severe Diarrhea Outbreak (Bloomberg)
Government, Regulatory & Legal
- FDA authorized Zyn nicotine pouches without knowing what they were made of, says former agency scientist (STAT)
- US FDA sued for allowing unauthorized vaping products (Reuters)
- CVS settles with FTC, agrees to count TrumpRx drug purchases towards insurance (Reuters)
- AIDS activists slam Biden R&D deal with Gilead over HIV prevention drug patents (STAT)
- UnitedHealth’s questionable review, and more MA stars lawsuits (STAT)
- A health tech workaround is under fire (Endpoints)
- South Africa's iDexis appeals court ruling over compounded weight-loss drugs (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.
