Recon: WHO releases first interim list of medical device authorities; AstraZeneca using AI to hedge late-stage risks

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US

• White House offers its science blueprint: More AI, less life sciences (STAT)
• Ahead of hearing, FDA questions the efficacy of Capricor’s Duchenne drug (STAT)
• FDA approves Freenome's blood test for colorectal cancer screening (Reuters)

In Focus: International

• WHO Names First Medtech Regulators Ready For Listed Authority Status (MedTech Insight)
• Germany’s Prevention Offensive Must Cover Cardio, Diabetes, Wound Care, Say Medtechs (MedTech Insight)
• EMA Endorses New First-Line Roles For Enhertu, Trodelvy In Breast Cancer (Pink Sheet)
• Roche’s Eye Implant Susvimo Set For EU Approval After Earlier Challenges (Pink Sheet)
• EMA’s PRIME Scheme Sets First-Half Record, Eclipsing Its Weakest Full Year Intake (Pink Sheet)

Pharma & Biotech

• New data on Eli Lilly’s ‘triple-G’ drug leave open questions on heart benefit (STAT)
• Sleep apnea pill developer Apnimed targets $608 million valuation in US IPO (Reuters)
• AstraZeneca's rare disease drug misses main goal in late-stage trial (Reuters)
• Sarepta names former Abbvie president as CEO as Ingram retires (Reuters)
• Exclusive: Schrödinger CEO 'couldn't be more pleased to be wrong' in launch of AI agent Bunsen (Endpoints)
• MapLight’s schizophrenia drug dampens once-daily hopes despite Phase 2 win (Endpoints)
• AstraZeneca looks to AI to ease risk in late-stage trials, speed up filings (Endpoints)

Medtech

• Goldman Sachs Alternatives buys control of Italian medtech firm Numantec (Reuters)
• Why Aidoc is taking a generative AI device to the FDA (MedTech Dive)
• Boston Scientific removes stroke prevention catheter after injury (MedTech Dive)
• GE HealthCare CFO Jay Saccaro steps down (MedTech Dive)
• Edwards posts strong TAVR sales ahead of potential Medicare coverage expansion (MedTech Dive)
• Acute Care AI Pioneer Viz.ai Takes First Step Into Chronic Brain Disease (MedTech Insight)
• CareDx CEO On Precision Diagnostics Pivot, Oncology Expansion (MedTech Insight)

Food & Nutrition

• As some medical schools embrace RFK Jr.’s nutrition push, they deftly sidestep MAHA priorities (STAT)
• India firm on 'energy drink' crackdown despite Pepsi, Red Bull, Monster protest (Reuters)

Government, Regulatory & Legal

• Why the FDA’s top spot could sit empty for months (MedTech Dive)
• PEPTIDE-L WAVE! PCAC Approves Four Bulk Drug Substances for the 503A List (FDA Law Blog)
• New ADVOCATE Analysis Backs Tavneos Efficacy, Amgen Tells US FDA In Withdrawal Dispute (Pink Sheet)

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.