Recon: FDA warns Applied Therapeutics over clinical trial handling; Roivant to halt sarcoidosis drug development

• In RFK Jr.’s promise to go after ‘big food,’ some public health officials see a silver lining (STAT)
• Pfizer, Eli Lilly execs push back as senators scrutinize drugmakers’ telehealth moves (STAT)
• Humana CFO Susan Diamond to step down in latest management change (Reuters)
• Can US FDA Dodge DOGE? Return To Office Mandate May Be Biggest Hit (Pink Sheet)
• UK MHRA Reminds Industry Of Looming Deadline For New Packaging Requirements (Pink Sheet)

• Exclusive: Novo Nordisk India execs urge early Wegovy launch as weight-loss rival looms (Reuters)
• CSL Seqirus inks bird flu vaccine supply pact with UK after similar deals in US, Europe (Fierce Pharma)
• UK secures over 5 million H5 influenza vaccine doses as pandemic precaution (Reuters)
• Neo Medical Proclaims EU MDR Portfolio Success (MedTech Insight)
• South Korea’s Regulatory Science Council Targets Enhanced Standards (MedTech Insight)
• EMA PRIME Scheme: Two New Entries, 10 Rejections & One Withdrawal (Pink Sheet)
• English NHS Failing to Meet Targets For Availability Of NICE-Approved Cancer Drugs (Pink Sheet)
• India Regulatory Reform: ‘Redeliberation’ At SECs Tightened, ‘Unnecessary Load’ Reduced (Pink Sheet)

• Roivant to stop lung disease drug development after trial failure (Reuters)
• Biogen expects steady growth for Alzheimer's drug Leqembi in near term (Reuters)
• There’s an effective treatment for menopause symptoms. Why do so few women use it? (STAT)
• Is this the beginning of the AI-in-drug-discovery era, or the beginning of the end? (STAT)
• Ipsen secures rights to preclinical T cell engager in $610M pact with French biotech (Endpoints)
• Relay licenses cancer drug to Korean biotech for $75M (Endpoints)
• Takeda to pay $200M for rights to anemia drug from Keros (Endpoints)
• Cartesian tees up Phase 3 mRNA CAR-T study in myasthenia gravis (Endpoints)
• BMS inks deal with AI Proteins; Terns’ early-stage leukemia data (Endpoints)
• After deal about-face and a spinout, Maze assembles $115M Series D (Endpoints)

• Using AI to design small molecule drugs is tough. Here are five companies trying to crack the code (STAT)
• How CMR Surgical is taking on robotics’ ‘800-pound gorilla’ (MedTech Dive)
• Movano receives FDA nod for smart ring’s pulse oximeter feature (MedTech Dive)
• GE Healthcare to buy radiopharmaceutical firm Nihon Medi-Physics (MedTech Dive)

• The invisible wasteland of health care data (STAT)
• Private Medicare insurers are likely to benefit in Trump’s new administration (STAT)
• E. coli outbreak tied to McDonald's Quarter Pounders has ended, CDC says (Reuters)
• US FDA Revises Guidance Best Practices, Declines Detailed Public Comment Summaries (Pink Sheet)
• How Many Hours are Really in a Day? (FDA Law Blog)