Recon: FDA rejects AstraZeneca’s lupus therapy Saphnelo; MAHA movement turns to dismantle state vaccine laws

• New data shows how HHS is implementing Trump AI mandates (STAT)
• FDA officials push for long-term monitoring of autoimmune patients receiving CAR-T therapy (STAT)
• AstraZeneca gets CRL for self-injectable pen version of lupus drug Saphnelo (Endpoints)
• Buoyed by Kennedy's success, MAHA groups take aim at state vaccine laws (Reuters)
• Senior FDA Official Under OIG Investigation Over Divorce, Assets (Bloomberg)
• Wegovy maker Novo Nordisk appoints Jamey Millar head of its US business (Reuters)

• From Croatia to MAHA: How an unapproved drug became the next hot peptide (STAT)
• WHO says first five patients evacuated via Gaza's Rafah crossing (Reuters)
• Acceptance Of Foreign Clinical Data Enshrined In China’s Revised Drug Law (Pink Sheet)
• Regulatory tracker: Acadia expects EU snub in Rett syndrome (Fierce Pharma)

• Novo Nordisk's next-gen obesity drug outperforms Wegovy in late-stage diabetes trial (Reuters)
• Pfizer moves forward with its hopes for a monthly obesity drug (STAT)
• Pfizer’s Metsera-originated monthly GLP-1 cuts weight by 10.5% at six months (Endpoints)
• Ultragenyx unwraps data that may be central to its gene therapy resubmission (Endpoints)
• Exclusive: Stanford duo joins AI scientist race with startup backed by a16z and Menlo (Endpoints)
• Carbon Health files for bankruptcy, seeking to sell or restructure (Endpoints)
• Novo Nordisk’s CagriSema bests semaglutide in type 2 diabetes study (Endpoints)
• GSK gives back rights to Wave Life Sciences' lead RNA editing program (Endpoints)
• Merck's 2026 outlook clouds upbeat fourth-quarter results (Reuters)
• AbbVie has ‘Love in Mind’ with new migraine educational campaign (Fierce Pharma)

• Boosting Your Brain With a Chip Carries a Price (Bloomberg)
• Medical device maker Medtronic to buy CathWorks in up to $585 million deal (Reuters)
• Beta Bionics receives FDA warning letter (MedTech Dive)
• STAAR names interim co-CEOs amid search for permanent leader (MedTech Dive)
• Time’s Up! QMSR Is Here. Device Makers Must Comply With New Regulatory Scheme (MedTech Insight)

• France Lowers Limit for Toxin in Baby Formula, May Spark Recalls (Bloomberg)
• McCormick tackles $50M tariff hit through pricing, other measures (Food Dive)

• First 10 Medicare-negotiated drug prices have taken effect: Are seniors really saving money? (Endpoints)
• We asked whether principal investigators have plans in place for how research can continue without them (STAT)
• AI could soon renew prescriptions without clinician help. Should the FDA make sure it’s safe? (STAT)
• STAT Plus:As U.S. officials move to reduce animal testing in research, focus may shift to restrictions on imports (STAT)
• Fearing ICE crackdown, immigrants nationally are avoiding treatment, sometimes with dire consequences (STAT)