Most Obamacare enrollment closes leaving Americans with higher bills or less health insurance (Reuters)
Exclusive: US FDA delays two drug reviews in new voucher program after safety, efficacy concerns (Reuters)
In Focus: International
Novo Nordisk Foundation gives $850M to nonprofit to help commercialize research in Europe (STAT)
BGI Genomics, Roche roll out diagnostic tests for Alzheimer's in China (Reuters)
UK Wary Of Complexities After EU ‘Unjams’ MDR (MedTech Insight)
‘Renewed EU-US Cooperation’: FDA & EMA Release AI Principles For Drugmakers (Pink Sheet)
Pharma & Biotech
Regeneron’s chief scientist on Trump’s drug pricing policy, gene therapy, and the problem with AI (STAT)
Pharma sector doubles down on AI amid hopes of slashing costs, timelines (Reuters)
Inside Fosun Pharma's ambition to be a global drug company (Endpoints)
FDA Change Gives New Hope for Osteoporosis Patients (Bloomberg)
Ocugen unwraps mid-stage data for eye disease gene therapy (Endpoints)
J&J reports positive Phase 3 data for Tecvayli in earlier blood cancer setting (Endpoints)
Scribe Therapeutics plans to test cholesterol-lowering epigenetic editing therapy (Endpoints)
Manufacturers benefit as pharma customers onshore to US, even as funding pressures persist (Endpoints)
Jazz sells priority review voucher for $200M, scoring highest price in a decade (Endpoints)
Health tech funding rounds get bigger when Andreessen Horowitz and General Catalyst join (Endpoints)
Weight-Loss Drugs Hold Promise of Big Savings for US Airlines (Bloomberg)
Medtech
Should Medicare automatically pay for medical devices that the FDA deems ‘breakthrough’? (STAT)
Altman’s Merge Raises $252 Million to Link Brains and Computers (Bloomberg)
Canon Eyes Possible Deals in Medical Devices and Chip Tools (Bloomberg)
5 topics to watch as MDUFA negotiations restart (MedTech Dive)
Edwards Lifesciences Disagrees With FTC Block on JenaValve But Gets Back To Business (MedTech Insight)
Food & Nutrition
Trump signs bill allowing whole milk back in school meals (Reuters)
Soybean Oil Surges With US Biofuel Quotas Expected by March (Bloomberg)
Government, Regulatory & Legal
Kaiser Permanente, DOJ reach $556 million Medicare Advantage fraud settlement, the largest of its kind (STAT)
My grandfather created the hepatitis B vaccine. Would he recognize public health in the U.S. today? (STAT)
After FDA’s pivot on clinical AI, we need AI safety research more than ever (STAT)
US Reports 168 New Measles Cases With Outbreak in South Carolina (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.
Adam Fisher, the staff director of the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), reported that the agency has approved 17 pharmaceuticals that utilize continuous manufacturing in their production.
The European Medicines Agency (EMA), in partnership with the European Commission (EC) and the Heads of Medicines Agencies (HMA), has published the first quarterly report on the state of clinical trials conducted in the EU and the European Economic Area (EEA). The report is intended to shed light on the progress being made to attract more clinical trials to the region and increase access to new treatments as part of the targets set by the EU in 2025.
An official from the US Food and Drug Administration (FDA) on Monday presented three case studies demonstrating how sponsors effectively utilized real-world evidence (RWE) and real-world data (RWD) to secure approval for their products.