Recon: Makary’s fate as FDA commissioner up in the air; Roche to buy PathAI for $750M

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

In Focus: US

FDA cliffhanger: Makary's fate in limbo (Axios)
White House considering naming FDA food chief as acting commissioner (Reuters)
Trump Is Planning to Fire FDA Commissioner Marty Makary (WSJ) (Reuters) (Politico) (The Atlantic)
Trump responds to reports FDA chief Mark Makary could be fired: 'Know nothing about it' (Fox)
Kennedy's health officials explored US ban of some widely used antidepressants (Reuters)
US FDA mulls repurposing approved drugs to expand access (Reuters)
Lilly's obesity pill tops 7,000 prescriptions in fourth week, signals modest uptake (Reuters)
Why we left the FDA: Six former officials share their stories (STAT)

In Focus: International

GSK plans to sell chronic hepatitis B drug in China through Sino Biopharm (Reuters)
Roche to buy PathAI for $750 million (STAT)
All passengers on hantavirus-hit ship considered high-risk contacts, EU health agency says (Reuters)
WHO says seven cases of hantavirus confirmed from cruise ship (Reuters)
Experts race to write guidance to contain first ship-borne hantavirus outbreak (Reuters)
NHS to grant Palantir contractors ‘unlimited access’ to patient data (FT) (Reuters)
MHRA invites views on proposed changes to medical device regulation (MHRA)
MHRA opens UK-wide consultation on redefining gene therapies (MHRA)

Pharma & Biotech

US FDA approves Partner Therapeutics' bile duct cancer drug under fast-track review (Reuters)
‘Pharma, not really’: Why AI’s top young talent isn’t interested in a career at big drugmakers (Endpoints)
Zuckerberg backed-Cellular Intelligence acquires Novo Nordisk's Parkinson's cell therapy (Reuters)
Biotech layoffs are easing, but is the worst over? (PharmaVoice)
Former FDA leaders, pharma speak out on mifepristone (STAT)
MHRA strengthens safety warnings for finasteride and dutasteride (MHRA)
European regulators greenlight first clinical test of GLP-1 gene therapy (Endpoints)
Braveheart Bio's Hengrui-licensed cardiac drug scores second clinical win (Endpoints)
Inhibrx says combo therapy shrank more tumors than Merck's Keytruda alone (Endpoints)
Five years after disaster, a rare disease community gets new chance at treatment (STAT)
CSL slashes revenue projection and takes $5B impairment as interim CEO flags R&D misses, market erosion (Fierce)
A Single Infusion Could Suppress HIV for Years, Study Suggests (NYTimes)

Medtech

MHRA Outlines Plans For CE Mark Recognition, Early Access Pathway (Medtech Insight)
New Hepta blood test could predict GLP-1 response (Fierce)
Medtronic to close California site amid restructuring (MedtechDive)
Mobia Medical Goes Public, Banking On Sole FDA-Approved Stroke Implant (Medtech Insight)
FDA grants de novo authorization to Aurie Reusable Intermittent Catheter System (Urology Times)

Food & Nutrition

Government, Regulatory & Legal

With Commissioner Under Pressure, FDA Opens Door to Flavored Vapes (NYTimes)
Capricor Therapeutics accuses Nippon Shinyaku of slow-walking plans on Duchenne drug (STAT)
CGMPs: Changing Good Manufacturing Practices (and Preemption) (Drug & Device Law)

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.