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Recon: FDA career staff say political pressure is affecting their jobs; Supreme Court rejects bid to weigh in on FDA stem cell regulation
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
Inside FDA, career staffers describe how political pressure is influencing their work (STAT)
The long history of euphemisms around the use of animals in lab research (STAT)
New US COVID guidance makes getting a shot harder (Reuters)
Trump's Tylenol claims limit M&A options for parent company Kenvue (Reuters)
Supreme Court passes on fight over FDA stem cell regulation (Endpoints)
FDA delays decision on Denali drug; Astellas’ Vyloy fails mid-stage pancreatic cancer trial (Endpoints)
In Focus: International
India's Tamil Nadu cancels licence of cough syrup-maker linked to child deaths (Reuters)
US biotech Nabla Bio, Japan's Takeda expand AI drug design partnership (Reuters)
EU Decision Time For Insmed’s Brensocatib & Sanofi’s Belumosudil (Pink Sheet)
UK MHRA Tells Device Users To Get Ready For Registration Fee Uplift (MedTech Insight)
Pharma & Biotech
Kailera Therapeutics, an obesity drug startup, raises $600 million (STAT)
BioCryst deepens rare diseases focus with $700 million deal for Astria (Reuters)
US FDA Eager To Advance Oncology Registries (Pink Sheet)
Ethics Reviews A Sticking Point For EU Clinical Trials, Says Shionogi Policy Expert (Pink Sheet)
Shah Capital pushes for Novavax's sale on persistent underperformance, marketing missteps (Reuters)
Q&A with Nobel winner Fred Ramsdell on basic research in biotech, and the future of cell therapy (Endpoints)
A gene therapy pioneer reckons with the reality for ultra-rare diseases (Endpoints)
Exclusive: Bristol Myers, insitro extend research deal to find a drug for new ALS target (Endpoints)
Obesity biotech Kailera gets $600M to start Phase 3 this year (Endpoints)
Lila Sciences closes $350M Series A for its AI-doing-science vision (Endpoints)
Kardigan raises $254M to test cardio drugs from Sanofi, BMS and Ionis (Endpoints)
Virtual digestive care startup Cylinder Health adds evidence to its approach of treating GI symptoms (Endpoints)
Medtech
Lyra launches ‘clinical-grade’ chatbot amid growing concern about mental health and AI (STAT)
J&J to spin off orthopedics business, sees 2026 sales growth of over 5% (Reuters)
Current Opportunities and Challenges in RWE and its Future with AI (FDA Law Blog)
Cybersecurity triggers another recall of J&J’s Impella heart pump controller (MedTech Dive)
Food & Nutrition
CDC team running top survey on health and nutrition is laid off (STAT)
California becomes first state to ban ultraprocessed foods in schools (Food Dive)
Government, Regulatory & Legal
The Health-Care Debate That’s Driving the Shutdown (Again) (Bloomberg)
How Much Are Drug Companies Exposed To US Government Programs? (Pink Sheet)
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.