Recon: FDA clears Dupixent for treating chronic hives; Administration sets new direction for AI

• When should six drugs count as one? The answer could be a big deal for pharma companies (STAT)
• How to think about Trump’s pharma tariffs — before they hit (STAT)
• CMS would absorb 340B drug discount program under leaked HHS reorganization proposal (Endpoints)
• Makary seeks to limit industry’s role in FDA advisory panels (MedTech Dive)

• In Ireland, a global hub for the pharma industry, Trump tariffs are a source of deep worry (STAT)
• Exclusive: VelaVigo inks another US biotech deal as China drug development scene booms (Endpoints)
• China startup injects CRISPR therapy into the brain for the first time (Endpoints)
• US drugs rely heavily on ingredients made overseas, new report shows (Endpoints)

• Immunovant replaces CEO, makes other changes as Roivant tightens control (STAT)
• Gilead says its therapy delayed growth of tumors in aggressive form of breast cancer (STAT)
• FDA approves blockbuster Dupixent for chronic hives (STAT)
• Gilead says Trodelvy-Keytruda combo effective for aggressive breast cancer type (Reuters)
• Roche discontinues low dose in Huntington’s trial, will switch patients to high dose (Endpoints)

• In directives to federal agencies, Trump charts a different course for AI (STAT)
• Intuitive, Boston Scientific and Edwards next up in medtech earnings (MedTech Dive)
• Ceribell wins FDA nod for algorithm to detect pediatric seizures (MedTech Dive)
• Illinois, Minnesota join FTC challenge against $627M Surmodics buyout (MedTech Dive)
• Illumina, Tempus AI partner to drive genomic testing beyond cancer (MedTech Dive)
• OneCell Diagnostics – Now 1Cell.Ai - Launches Multi-Modal Cancer Diagnostic Panel OncoIncytes (MedTech Insight)
• Upcoming CMS Meetings Address Tremor-Control Devices, Lab Test Reimbursement (MedTech Insight)
• Precision Neuroscience’s FDA Clearance For Core Component Of Brain Implant Expected to Accelerate R&D (MedTech Insight)

• FDA budget cut proposal puts states in charge of routine food inspections (Food Dive)
• FAO Reports on Future of New Food Sources and Production Systems (Food Safety)

• In Braidwood v. Kennedy, Supreme Court is hearing challenge to ACA rule requiring free preventive care (STAT) (Reuters)
• Five priorities to remake the FDA in a time of deep uncertainty (STAT)
• Health care industry, worried millions could lose ACA insurance, pushes for Trump to delay changes (STAT)
• Where Does Rare Disease and Patient-Focus Fall into Commissioner Makary’s Priorities & the MAHA Platform for FDA? A New Ultrarare Approval Pathway & More (FDA Law Blog)