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August 5, 2025
by Jason Scott

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)
In Focus: International                                                                                                       
  • 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)
Pharma & Biotech
  • 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)
Medtech
  • 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)
Food & Nutrition
  • 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)
Government, Regulatory & Legal  
  • 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)
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.
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