Recon: Digital health, device leaders leave FDA; Walmart, Target get warning letters for recalled infant formula

• Pfizer foresees challenging 2026 on fading COVID sales, margin pressure (Reuters)
• AstraZeneca, Daiichi's breast cancer drug gets FDA nod as first-line treatment (Reuters)
• Biotech Share Sales in US Deliver Biggest Quarter Since 2021 (Bloomberg)
• US FDA Commissioner Makary Continues Pushing Boundaries With Novartis Photo-Op (Pink Sheet)
• Key digital health and device leaders depart FDA (STAT)

• We crunched the numbers on drug discovery in the U.S. vs. China. The results were alarming (STAT)
• South Korea's ADEL signs up to $1.04 billion Alzheimer's drug development deal with Sanofi (Reuters)
• Sanofi licenses Korean biotech’s tau-targeting Alzheimer’s drug for $80M upfront (Endpoints)

• Facing multibillion-dollar patent cliff, Pfizer plans slew of obesity trials (Endpoints)
• Nektar to advance alopecia drug to Phase 3, despite ‘violations’ in trial (Endpoints)
• Ambros Therapeutics, Ramaswamy’s latest startup, launches with plans for pain treatment (STAT) (Endpoints)
• In a banner year for biopharma, here are the best industry CEOs of 2025 (STAT)
• J&J backs financing round for Stanford CAR-T cell therapy spinout Link Cell (Endpoints)
• Caris signs Genentech deal worth up to $1.1 billion for rare cancer targets (Reuters)
• Gene Editing Superstars Team Up to Make Cheaper Rare Disease Cures (Bloomberg)
• Gilead's single-tablet HIV combo of bictegravir, lenacapavir passes another late-stage test on way to filings (Fierce Pharma)
• Novo gets FDA warning letter at troubled Indiana site formerly owned by Catalent (Fierce Pharma)

• Calming nerves with a hot wearable (Endpoints)
• Philips to acquire SpectraWAVE (MedTech Insight)
• FDA gets mixed feedback on performance monitoring for AI (MedTech Dive)

• Free pass or failing grade for saturated fats? Review sets off scientific and political debate (STAT)
• FDA sends warning letters to Walmart, Target for selling recalled baby formula (Reuters)

• Medline Survives Delays on Road to Biggest US 2025 IPO (Bloomberg)
• Where does the NIH go from here? (STAT)
• Avalere taps longtime Senate staffer to head up healthcare policy team amid regulatory turbulence (Fierce Pharma)
• Kennedy approves adding two rare disorders to newborn screenings (Reuters)
• Speaker Blocks House Moderates’ Push to Vote on Health Subsidies (Bloomberg)
• CMS considers expanding TAVR coverage to asymptomatic patients (MedTech Dive)