Recon: FDA approves Merck’s HIV pill combo; Moderna gets EU nod for combined flu, COVID shot in older patients

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

In Focus: US

How Trump is pushing psychedelics reform through the health agencies (STAT)
Trump order to advance psychedelic treatments generates excitement — and worries (STAT)
A criminal sentence for OxyContin maker Purdue Pharma clears the way for completing its settlement (STAT)
COVID shots, newer vaccines in limbo after US court halts Kennedy’s advisory panel (Reuters)
US FDA approves Merck's pill combo to treat HIV infection (Reuters)

In Focus: International

Biogen buys China rights to immune disease drug in up to $850 million deal with TJ Biopharma (Reuters)
Boehringer Ingelheim to expand its AI footprint in UK, in £150M investment (Endpoints)
Exclusive: Boots owners hire consultants for overhaul before possible London IPO in 2027, sources say (Reuters)
World's top condom maker Karex to raise prices sharply as Iran war strains supply chain (Reuters)
Moderna wins EU approval for combined flu, COVID shot for older adults (Reuters)
Germany risks missing out on new drugs, AstraZeneca CEO tells paper (Reuters)
AI Medtech Regulation In Limbo After EU Rules Simplification (MedTech Insight)

Pharma & Biotech

In early trial, CAR-T results raise hope of preventing multiple myeloma in high-risk patients (STAT)
Former banker brought on to revitalize Pfizer’s strategy departs his post (STAT)
BioAge says experimental pill aimed at reducing heart risks significantly reduced inflammation (STAT)
Tortugas Neuroscience launches with hopes to develop drugs for brain disorders, other conditions (STAT)
Is this pancreatic cancer's 'Herceptin moment'? Revolution Medicines' breakthrough offers hope (Endpoints)
Flagship’s latest startup aims to solve gene therapy’s thorniest technical challenge (Endpoints)
Soleno sold at a discount to Neurocrine due to dwindling European prospects (Endpoints)
Novartis has its anticoagulant back. Now it's cutting two programs (Endpoints)
One of Kelonia's key investors will clear a 45-fold return on startup's sale to Lilly (Endpoints)

Medtech

Medtronic leads $100M investment in Pulnovo Medical (MedTech Dive)
MiniMed posts double-digit sales growth, widening net loss (MedTech Dive)
Medtronic closes $585M purchase of CathWorks (MedTech Dive)
STORM-PE 90-Day Data: CAVT Patients Walk 111 Meters Further Than Anticoagulation Alone (MedTech Insight)

Food & Nutrition

Senate bill floats workaround for hemp THC beverage ban (Food Dive)
4 tech tools food brands are using to enhance inventory, demand planning (Food Dive)

Government, Regulatory & Legal

FDA’s Pep(tide) Rally! What Compounders and Industry Need to Know (Post 1 of 2) (FDA Law Blog)
CMS to ask every state for new audits of health care providers (STAT)
The U.S. health care system is built around looking backward (STAT)
The contradiction at the heart of Republicans’ embrace of psychedelics (STAT)
Where Utah’s experiment with AI doctors is headed next (Endpoints)
UnitedHealth's strong first quarter and forecast cheers up Wall Street (Reuters)
Study Reveals How People Talk To AI About Health (MedTech Insight)

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.