Recon: UK, US ink deal for zero-tariffs on pharma products; EUDAMED notice heralds new era of compliance

• 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)