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)
- 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)
- 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)
- 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)
- 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)
- 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)
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