Recon: Eli Lilly’s obesity pill assisted in weight loss maintenance after injection switch; Takeda’s AI-generated psoriasis therapy sees Phase 3 success
Recon: Eli Lilly’s obesity pill assisted in weight loss maintenance after injection switch; Takeda’s AI-generated psoriasis therapy sees Phase 3 success
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
Amid talk of a brain drain, some scientists leave U.S. behind (STAT)
We crunched the numbers on drug discovery in the U.S. vs. China. The results were alarming (STAT)
Eli Lilly’s obesity pill helped patients maintain weight loss after switch from injections (STAT)
In Focus: International
Moderna lands CEPI as new backer for its pandemic flu program (Endpoints)
UK Grapples With Disruption in Supplies of Epidural Infusions (Bloomberg)
MHRA And HSA Lay UK-Singapore Path To Closer Medtech Harmonization – ‘But SMEs Take Heed’ (MedTech Insight)
Fragmented Governance Must Be Tackled As Part Of EU Medtech Revision (MedTech Insight)
Pharma & Biotech
Novo files marketing application for next-gen weight-loss drug (Reuters)
Hospitals owned by real estate investors more likely to close or go bankrupt (STAT)
In major effort to end gender-affirming care, Trump administration takes aim at hospitals (STAT)
What I’ve learned by mapping the impacts of NIH cuts (STAT)
Medicare enrollees to pay 50% less for some drugs in 2025, report says (Reuters)
Trump to announce Medicare pilot program to pay for CBD treatments, report says (Reuters)
Consultant: Medicare Payment Changes May Expand Home Cardiac Monitoring and Reshape RPM Market (MedTech Insight)
New York Giants team doctor: Clinics offering ‘miracle injections,’ ‘next generation cell therapies’ are selling false hope (STAT)
Employers drop coverage for weight loss drugs as pharma’s direct-to-consumer programs grow (STAT)
Americans facing soaring health insurance costs may get a lifeline in 2026, experts say (Reuters)
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 US Food and Drug Administration (FDA) issued final guidance on 13 August regarding the types and timelines for formal meetings that sponsors can request during the development of new drugs and biological products.
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation, and what we’re reading from around the web.
Industry and other stakeholders want the US Food and Drug Administration (FDA) to provide more clarity and ensure flexibility in a revised guidance on how drug and medical device makers should communicate with payors and other stakeholders about their products.