Recon: FDA names new chief counsel; Trump says pharma imports to face ‘small tariff' at first
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- FDA Chief Says He Wants Gene Therapy Head Prasad to Return (Bloomberg)
- US to initially impose 'small tariff' on pharma imports, Trump says (Reuters)
- US FDA names Sean Keveney as chief counsel (Reuters)
- After ‘conflicting’ signals from FDA, rare disease drugmaker contemplates closure (STAT)
- Americans should have access to drugs approved overseas (STAT)
- First Corcym aortic valve implanted via new robotic procedure (MedTech Dive)
- Novo Nordisk faces investor lawsuit over 'false and misleading' semaglutide sales projections (Fierce Pharma)
- ‘Unprecedented’ FDA Leaks Sow Confusion For Patients, Sarepta and Capricor (BioSpace)
- German biotech plans Phase 3 study for ex-Sanofi depression drug despite mid-stage miss (Endpoints)
- Innogen Pharma Said to Take Orders This Week for Hong Kong IPO (Bloomberg)
- EMA Tackles Guidance Void As Proposals For External Controls Grow (Pink Sheet)
- Plans For EU Biotech Act Shift Up A Gear (Pink Sheet)
- India's Gland Pharma posts quarterly profit rise on Cenexi recovery, Europe sales growth (Reuters)
- Japan Gives Global-First Recommendations To Taisho’s Vornorexant, Santen’s Sepetaprost (Pink Sheet)
- Vaccine Developers To Benefit From CEPI’s ‘World First’ Adjuvant ‘Matchmaking’ Service (Pink Sheet)
- For some, a new approach to infertility is revolutionary. For others, it’s old wine in a new bottle (STAT)
- Vertex next-generation pain candidate fails Phase 2 trial (STAT)
- Pfizer bumps up EPS guidance, factors in some policy thorns (Endpoints) (Reuters)
- Altos Labs hires a new medical chief with mTOR experience, Novartis chops (Endpoints)
- Animal healthcare firm Zoetis raises annual forecast on strong pet product demand (Reuters)
- Hims & Hers falls as declining subscriber base weighs on revenue (Reuters)
- New Incyte CEO takes 'fresh look' at business, outlines BD plan (Fierce Pharma)
- BioMarin touts pipeline asset as potential Voxzogo replacement (Fierce Pharma)
- Y-mAbs shares spike on $412M buyout by SERB Pharmaceuticals (Fierce Pharma)
- Medical products maker Smith+Nephew soars as turnaround plan boosts profit (Reuters)
- A brain-computer interface lets him control an iPad with his thoughts (STAT)
- I’ve spent 30 years trying to harness AI to fight cancer. I’m dismayed by the AI pseudo-revolution (STAT)
- Former X CEO Yaccarino takes helm at digital health company eMed (Reuters)
- AI In Clinical Research: Benefits Across The Board, But ‘Nirvana’ Still Out Of Reach (Pink Sheet)
- J&J’s Ethicon Issues Class I Correction For Echelon Stapler Reloads Amid Lockout Risk (MedTech Insight)
- The GOP Is Choosing Pesticides Over the MAHA Moms (Bloomberg)
- RFK Jr. is waging a war against ultra-processed foods. What does it mean for your diet? (USA Today)
- The FDA is targeting orange juice. Here’s why, and what the science says. (WSJ)
- AIDS activists sue HHS to obtain Gilead settlement over patents for HIV prevention pills (STAT)
- Amgen, Lilly can continue fight over alleged improper drug discounts, judge rules (Endpoints)
- Court Allows MSN Marketing Of Entresto Generic, But More Legal Issues Pending (Pink Sheet)
- August Brings Fresh Faces And Tough Calls To US FDA User Fee Calendar (Pink Sheet)
- Federal Court Declares FDA’s Civil Monetary Penalty Provisions For Tobacco Products Unconstitutional (FDA Law Blog)
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