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March 25, 2025
by Jason Scott

Recon: GSK reviews whether shingles jab reduces dementia risk; Axsome ADHD hits goal in late-stage trial

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US
  • Health insurers’ rapid adoption of AI tools is outpacing regulators’ ability to keep watch (STAT)
  • Trump picks Susan Monarez to run the CDC (STAT)
  • Lawmakers are pushing the HALT Fentanyl Act as the solution to the overdose crisis. Experts warn it will fall short (STAT)
  • Axsome's ADHD drug meets main goal in late-stage study (Reuters)
  • US FDA Under Makary: MAHA With A Lighter Touch (Pink Sheet)
In Focus: International
  • GSK studying if best-selling shingles vaccine lowers dementia risk (Reuters) (Pharmaphorum)
  • UK weight loss market: M&A opportunities (Pharmaphorum)
  • Japan Expands Priority R&D List For Regular Vaccinations (Pink Sheet)
  • EU Marketing Approval Gap Between Lilly’s Donamemab and Eisai’s Leqembi Could Narrow (Pink Sheet)
  • AstraZeneca, Pfizer rebuked over breaking UK drug marketing rules on LinkedIn use (Fierce Pharma)
Pharma & Biotech
  • Impatient about cell and gene therapy? Progress in biotech is not always linear (STAT)
  • Another immunology biotech emerges as Hillstar takes flight with $67M (Endpoints)
  • Ophthalmology startup Character Biosciences gets $93M for genetics-based approach (Endpoints)
  • FDA starts review of Sanofi's MS hope tolebrutinib (Pharmaporum)
  • Study Shows ‘Insurer-PBMs’ Dominate Medicare Part D, Steer Patients to Their Pharmacies (Pink Sheet)
  • Cassava Sciences' controversial Alzheimer's drug fails in second late-stage study (Reuters)
  • Activist investor Keith Meister to join Illumina's board (Reuters)
Medtech
  • 5 tips for building a predetermined change control plan (MedTech Dive)
  • Urine Test Could Halve Number Of CT Scans For Patients With Kidney Cancer (MedTech Insight)
  • Roche’s Bet On Next-Gen Sequencing Poses New Challenge For Illumina’s Market Dominance (MedTech Insight)
  • New CLIA Rule Updates Personnel Policies (MedTech Insight)
Food & Nutrition
  • Mississippi Becomes Third State to Ban Sale of Cell-Based Meat, Following Florida, Alabama (Food Safety)
  • RFK Jr.’s Plan to Test Baby Formula Clashes With FDA Staff Cuts (Bloomberg Law)
  • A movement to ban food dyes gains ground across the U.S. (NBC)
Government, Regulatory & Legal
  • NIH is removing some outside scientific advisers who evaluate agency research (STAT)
  • Cuts to Medicaid will set the U.S. back 35 years in dementia care (STAT)
  • Three major questions on pharma tariffs Trump claims are on the way (Endpoints)
  • AbbVie files trade secrets suit against ADC competitor (Endpoints)
  • Mifepristone Filing Supports 2023 US FDA Actions, But Experts Caution Against Overanalyzing (Pink Sheet)
  • Schedule III Marijuana Would Still Be Regulated Marijuana (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.
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