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With new vaccine schedule secured, RFK Jr. allies head to statehouses (STAT)
ARS Pharma TV ad for Neffy needled by FDA in untitled letter (Fierce Pharma)
Sanofi vaccine sales face headwinds from US policy shifts (Reuters)
US names HIV, arthritis drugs for next Medicare price talks (Reuters)
Elon Musk's Neuralink says it has 21 participants enrolled in trials (Reuters)
In Focus: International
AstraZeneca sets out $15 billion China investment during Starmer visit (Reuters)
Roche earnings edge up 5% as forex effects weigh on drug sales growth (Reuters)
Pressure grows on ministers to end secrecy over UK medicines deal with Trump (The Guardian)
Sanofi says its €15B dealmaking budget, R&D spend should help ease looming Dupixent patent cliff (Endpoints)
Pakistan becomes latest Asian country to introduce checks for deadly Nipah virus (Reuters)
UK Warns of Severe Pancreatitis, Deaths Tied to Wegovy, Mounjaro (Bloomberg)
Covid Left Lasting Rise in Deaths in Rich Countries, Study Shows (Bloomberg)
Pharma & Biotech
AI biotech founded by ex-Google CEO Eric Schmidt is raising $150 million (STAT)
US FDA places clinical hold on Regenxbio's rare disease program (Reuters)
ImmunityBio’s Soon-Shiong mischaracterized talks with FDA over cancer drug, sources say (STAT)
Why I decided to share all my health information with ChatGPT Health (STAT)
Agomab anticipates $182M IPO as it builds fibrosis pipeline (Endpoints)
Summit says FDA will decide to approve its cancer drug by November (Endpoints)
Sanofi vows to stay committed to vaccines as portfolio takes a hit (Endpoints)
The disrupted fate of pharmacy startups (Endpoints)
Medtech
CDRH on track for review timelines despite staff cuts (MedTech Dive)
Thermo Fisher forecasts 2026 profit below estimates on research funding cuts (Reuters)
Cleveland Diagnostics names Michael Iskra CEO (MedTech Dive)
Medtech M&A took off in the second half of 2025: report (MedTech Dive)
Hey Doc, What’s That Sound? FDA Clearance Broadens Scope Of AI Heart Murmur Detection Platform (MedTech Insight)
Illumina Pins 2026 Growth On Clinical Sequencing As Research Spending Stays Constrained (MedTech Insight)
When Brain-Computer Interfaces Fail, Human Trial Participants Have Few Options (MedTech Insight)
Food & Nutrition
It’s Trendy to Mimic Breast Milk, But Formula Makers May Be Adding Risks (Bloomberg)
Bain, Blackstone Among Suitors for UK Vitamin Maker Vitabiotics (Bloomberg)
Government, Regulatory & Legal
US life expectancy hit an all-time high in 2024, CDC says (STAT)
HHS appoints 21 new members to federal autism advisory committee (STAT)
Secretary Kennedy names new chair, 10 members to federal Alzheimer's advisory panel (Reuters)
Kaiser Permanente, DOJ reach $556 million Medicare Advantage fraud settlement, the largest of its kind (STAT)
Do pediatricians make large profits from vaccines? (STAT)
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.
Three major pharmaceutical industry groups—two in the US and one in India—have called for changes to the US Food and Drug Administration's (FDA) Scale-Up and Post-Approval Changes (SUPAC) guidelines. They believe these guidelines should be updated to reflect more modern manufacturing methods and better align with International Council for Harmonisation (ICH) standards.
Patients with breast cancer said faster approval times for oncology products, as a trade-off for evidentiary certainty, is most permissible in situations where there are no treatment alternatives, the results from a recent qualitative study suggest.