Recon: FDA clears Dupixent for treating chronic hives; Administration sets new direction for AI
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- 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 Focus: International
- 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)
Pharma & Biotech
- 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)
Medtech
- 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)
Food & Nutrition
- 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)
Government, Regulatory & Legal
- 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)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
