Recon: J&J’s Spravato gets FDA approval for depression monotherapy; Chinese biotechs encroach on US drugmakers' dominance
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Trump orders US exit from World Health Organization (Reuters)
- What can’t GLP-1s do? Study maps benefits while warning of uncommon risks (STAT)
- Trump’s initial orders reverse Biden on health care costs, protections from discrimination (STAT)
- Three former FDA officials: Here’s what Trump and his nominees need to know (STAT)
- A next-generation form of chemotherapy wins FDA approval (STAT)
- Johnson & Johnson Gets FDA OK For Spravato as Monotherapy (MarketWatch)
In Focus: International
- Germany’s ITM, a stalwart in radiopharmaceuticals, gets ready to take its own shots (STAT)
- China's biotech boom is threatening US drugmakers' dominance (Endpoints)
- Why Big Pharma Will Continue To Choose India For Clinical Research In 2025 (Pink Sheet)
- European Pharmacopoeia Adopts New Standards To Accelerate mRNA Vaccine Development (Pink Sheet)
- Germany to lobby Trump on WHO withdrawal, agency hopes for U-turn (Reuters)
Pharma & Biotech
- With support from NFL owner Jeffrey Lurie, Icelandic biotech closes Series A for oral Alzheimer's drug (Endpoints)
- Sionna and Odyssey end JPM week with IPO filings (Endpoints)
- FDA puts Atara’s INDs on hold after rejection; Ascletis' safety data for obesity pill (Endpoints)
- Ascentage estimates $133M in proceeds as it plans Nasdaq dual listing (Endpoints)
- Leo bags EU rights to Junshi’s Loqtorzi, putting marketing muscle behind PD-1 launch (Fierce Pharma)
- Sanofi's consumer health arm Opella secures FDA green light to pursue OTC Cialis study (Fierce Pharma)
Medtech
- Medtronic names Thierry Piéton as CFO (MedTech Dive)
- Study: How Cost And Timeline Uncertainty Plague Medtech In The EU (MedTech Insight)
- New president, new rules: Trump rescinds Biden’s AI order (STAT)
Government, Regulatory & Legal
- Exiting Medicare director expects current law to guide next price negotiations (Endpoints) (Bloomberg)
- What to make of UnitedHealth Group’s rebate move (Endpoints)
- Walgreens Plunges After US Alleges Improper Opioid Dispensing (Bloomberg)
- Sage sues Biogen as analyst detects little interest in buyout at original offer price (Fierce Pharma)
- FDA Recommends Disclosure of Plant Source in Draft Guidance on Labeling Plant-Based Alternatives (FDA Law Blog)
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.
