Recon: Supreme Court takes up ‘skinny labeling’ case; EC proposal would double EU regulators medtech staffs
Recon: Supreme Court takes up ‘skinny labeling’ case; EC proposal would double EU regulators medtech staffs
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
Tylenol use during pregnancy not linked to autism, new study says (STAT)
Supreme Court agrees to review ‘skinny labeling’ and generic drug access (STAT)
Limit on multiyear funding of NIH grants is a sticking point in Senate budget talks (STAT)
Some drugmakers quietly concerned about legal risk with speedy FDA review program (Reuters)
Trump announces "The Great Healthcare Plan," but it's sparse on details (CBS News)
In Focus: International
Novo Nordisk Foundation gives $850M to nonprofit to help commercialize research in Europe (STAT)
Makary cites higher FDA user fees as one key to counter China biotech (Endpoints)
European regulators recommended 38 novel drugs in 2025, 15 fewer than the FDA (Endpoints)
Europe Relies Too Much on China for Drugs, Fresenius CEO Warns (Bloomberg)
Commission Proposal Expected To More Than Double EU Regulators’ Medtech Staff (MedTech Insight)
EY Study Lays Bare Extent Of Regulatory Toll On Europe’s Medtech Sector (MedTech Insight)
Pharma & Biotech
Novo's Wegovy pill makes encouraging start in weight-loss race vs Lilly (Reuters)
Genmab and AbbVie's blood cancer drug fails to improve survival in late-stage study (Reuters)
Agomab and SpyGlass file for IPOs as investor enthusiasm builds after JPM (Endpoints)
Large drugmakers without a US pricing pact are bracing to make one (Endpoints)
Generic GLP-1s are coming this year. The CEO in charge doesn't know what to expect (Endpoints)
ImmunityBio's cell therapy posts encouraging early results in rare form of lymphoma (Endpoints)
Medtech
Intuitive says general surgery, acute care fuel US robot momentum (MedTech Dive)
STAAR CEO exits after company rejects Alcon buyout (MedTech Dive)
Siemens Healthineers Targets 5–6% Growth, Rules Out Large M&A As Tariff Mitigation Takes Shape (MedTech Insight)
More Medtech Dialog And Supercharged Hospital And DRGs Reform In Packed 2026 German Agenda (MedTech Insight)
Philips Exec: Innovation Launches Breakthrough Era For Imaging (MedTech Insight)
Abandoning packaging sustainability is a ‘serious strategic miscalculation’: Bain (Food Dive)
Government, Regulatory & Legal
Former AMA president says the U.S. health care system will implode without an overhaul (STAT)
US Supreme Court to hear Bayer's bid to curb Roundup cases (Reuters)
The Push for Lower US Drug Prices Uses Bad Logic (Bloomberg)
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.
The top observations identified in Form 483 reports from inspections conducted under the recently implemented Quality Management System Regulation (QMSR) include risk management, outsourcing and purchasing, and complaint handling and feedback.
The European Parliament and Council have reached a provisional agreement on the Critical Medicines Act (CMA), moving proposals designed to tackle shortages of key medicines closer to law.