Recon: J&J’s Spravato gets FDA approval for depression monotherapy; Chinese biotechs encroach on US drugmakers' dominance

• 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)

• 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)

• 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)

• 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)

• 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• FDA Recommends Disclosure of Plant Source in Draft Guidance on Labeling Plant-Based Alternatives (FDA Law Blog)