Recon: UK, US ink deal for zero-tariffs on pharma products; EUDAMED notice heralds new era of compliance
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Prasad lays out stricter approach to FDA vaccine regulation (PoliticoPro)
- Experts say top FDA official’s claim that Covid vaccines caused kids’ deaths requires more evidence (STAT)
- Lilly slightly lowers self-pay prices for single-dose vials of Zepbound (Endpoints)
- Merck Seeks Up to $8 Billion in US Bond Sale Tied to Cidara Deal (Bloomberg)
- Distributors In Spotlight As OIG Highlights US Medicare’s Major Overspend On CGMs (MedTech Insight)
- À La Carte Clinical Trials? DCTs Promise Flexibility, But Reality Is Complex (Pink Sheet)
- US announces zero tariff pharmaceutical deal with Britain (Reuters)
- Ebola outbreak in Congo over, Congolese health officials and WHO say (Reuters)
- WHO backs use of GLP-1 therapies for obesity, warns access will remain limited (Reuters)
- Tanabe Pharma shifts gears for Bain-backed future, dropping Mitsubishi moniker after $3.3B deal (Fierce Pharma)
- EU Digital Omnibus Meets MDR And IVDR Revisions: Alignment Or Chaos? (MedTech Insight)
- Long-Awaited EUDAMED Notice Ushers In New Era Of Compliance (MedTech Insight)
- UK Budget: Little Mention Of Pharma, But Some Support For Innovators (Pink Sheet)
- A Look At How China’s Conditional Approval Scheme Has Been Working (Pink Sheet)
- Belite Bio aims for first approval of Stargardt disease treatment with Phase 3 success (Endpoints)
- Half of biopharma is now “heavy AI” — and they see a different future | Signal Pulse Report (Endpoints)
- Gene writing startup Tessera strikes $150M partnership with Regeneron (Endpoints)
- Protego gets $130M for AL amyloidosis drug from leaders behind Vyndaqel (Endpoints)
- Generate to launch Phase 3 TSLP drug studies, as AI bio enters its clinical era (Endpoints)
- Omnicom Health names IPG Health’s Dana Maiman CEO (Fierce Pharma)
- Postmarket Optimization Can Give Companies A ‘Competitive Advantage’ In Oncology (Pink Sheet)
- Building a better robot: How Virtual Incision plans to challenge Intuitive (MedTech Dive)
- J&J’s US orthopedic leader leaves amid DePuy spinout process (MedTech Dive)
- Philips Debuts Spectral CT With AI At RSNA 2025 (MedTech Insight)
- Ceribell’s Neonatal US Clearance Sets Up 2026 Growth Amid China Pressures (MedTech Insight)
- Private label’s allure transcends income levels, survey finds (Food Dive)
- FDA releases more inspection documents from ByHeart infant formula plants (Food Safety News)
- Chairman of vaccine committee leaves for new HHS job (STAT)
- Why first-generation mental health apps cannot ignore next-gen AI chatbots (STAT)
- One way to fight vaccine hesitancy: ditch the needles (STAT)
- BsUFA IV Is Coming: FDA Calls for Public Input (FDA Law Blog)
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.
