Recon: AbbVie forges $10.9 billion deal with Apogee; US FDA changes tack on Regenxbio's rare disease gene therapy
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- AbbVie to buy Apogee Therapeutics in nearly $11B deal (STAT)
- How Eli Lilly Got Huge By Making Us Thin (Bloomberg)
- Pharma goes on a spending spree, snapping up biotechs in a hurry (STAT)
- US FDA declines to approve Achieve Life Sciences' smoking-cessation drug (Reuters)
In Focus: International
- After 'redesign,' WuXi Bio sets new timeline for Massachusetts factory opening (Endpoints)
- South African court grants Novo Nordisk petition to block Ozempic copies (Reuters)
- Nuvectis gains two experimental drugs in licensing deal with China's Haisco (Reuters)
- Cobalt Users Say EU Health Rules Imperil Mineral Supply Push (Bloomberg)
- Ebola Cases Top 1,000 in Congo as Virus Infects Frontline Health Workers (Bloomberg)
Pharma & Biotech
- Sanofi names new R&D head as it tries to jump-start pipeline (STAT)
- FDA reverses course on Regenxbio’s childhood gene therapy after rejection (STAT) (Endpoints)
- Definium LSD therapy helped patients with major depression in late-stage trial (STAT) (Reuters)
- Merck's IBD drug from $10.8B Prometheus deal claims its first Phase 3 win (Endpoints)
- $25M ransom, no deal: Hackers claim Novo's drug recipes and AI models are for sale (Endpoints)
- MapLight to discuss future of autism drug with FDA despite Phase 2 disappointment (Endpoints)
Medtech
- FDA posts early alert over device used with Impella heart pumps (MedTech Dive)
- 4 diabetes tech execs on the future of multi-analyte glucose sensors (MedTech Dive)
- Practice And More Practice Makes Perfect: Surgical Science On Mission To Train More Surgeons (MedTech Insight)
- After Medtronic Exit, Nehme Charts A Staged Regulatory Path For Soft Robotics With Morph (MedTech Insight)
Food & Nutrition
- Beef tallow takeover? Big food companies begin to embrace MAHA ingredient (Food Dive)
- Denmark investigating multiple Salmonella outbreaks (Food Safety News)
Government, Regulatory & Legal
- Enough, already: the problem with clinical trial data collection (STAT)
- Health equity researchers fear unseen level of scrutiny under White House proposal (STAT)
- Early-Stage Medtech Funding Is Contracting – And The Pipeline Will Feel It (STAT)
- UK Leads The Way For Value-Based Procurement In Europe (MedTech Insight)
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.
