Recon: FDA approves Denali’s Hunter syndrome drug; Merck to buy Terns for $6.7B

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

In Focus: US

FDA approves Denali Therapeutics drug for Hunter syndrome (STAT)
Bhattacharya addresses CDC director role, works to bolster staff morale in first all-hands meeting (STAT)
CDC leadership in limbo as Trump administration set to miss deadline to nominate director (STAT)
Biopharma industry pushes back on FDA's 'America First' user fee proposals (Endpoints)
Post-Hoc: It’s time to make ACIP serious again (Endpoints)

In Focus: International

Iran War: Fuel Woes Exacerbate Fragility Of Europe’s Medicines Distribution System (Pink Sheet)
India Tightens Oversight Of GLP-1 Supply Chain Amid Concerns Of ‘On-Demand’ Availability (Pink Sheet)
Germany renews push for sugar tax and energy drinks ban for children (Reuters)

Pharma & Biotech

Merck braces for Keytruda patent loss with $6.7 billion Terns bet (Reuters)
Wegovy maker Novo sharpens consumer focus with board role for Mars CEO (Reuters)
Allogene’s off-the-shelf CAR-T is nearing an early but pivotal study readout (STAT)
Recordati says it's received a $12B+ takeover bid (Endpoints)
Wave crashes on obesity disappointment (Endpoints)
Corcept Therapeutics shares surge as lead drug gets FDA nod for ovarian cancer (Reuters)
Tom Brady-backed telehealth firm eMed valued at over $2 billion in latest funding round (Reuters)
Kodiak Sciences shares soar after eye drug succeeds in late-stage study (Reuters)

Medtech

CMR Surgical robot builds momentum ahead of US rollout (MedTech Dive)
Endologix to close production facility, lay off 31 people (MedTech Dive)
Manufacturers brace for price increases from Strait of Hormuz closure (MedTech Dive)
Medtronic lowers earnings forecast after MiniMed IPO (MedTech Dive)
Thermo Fisher completes $8.9B buyout of Clario (MedTech Dive)
Medtronic’s OmniaSecure defibrillation lead earns expanded FDA indication (MedTech Dive)
LSI Panel: Investors, Medtech Leaders Expect M&A Rebound In 2026, But Only For Strong Assets (MedTech Insight)
No Subscription, No Compromise: Ultrahuman Returns To US Market With Ring Pro To Take On Oura (MedTech Insight)
Medtronic Takes On Boston Scientific In Back Pain With ViaVerte BVNA Deal (MedTech Insight)

Food & Nutrition

California considers seal of approval for foods that are not ultra-processed (STAT)
Food safety nonprofit's lawsuit claims Panera Bread misled consumers, citing Reuters (Reuters)
AI is raising the stakes in functional ingredient formulation (MedTech Dive)

Government, Regulatory & Legal

Heart failure is common. A quick MRI could improve diagnosis and guide treatment (STAT)
AI Act Amendments Bring Relief Not Resolution (MedTech Insight)
US FDA Allergenics Staff Sees Single-Trial ‘Default’ As Helpful (Pink Sheet)
Outspoken ACIP member steps down amid vaccine panel uncertainty: reports (Fierce Pharma)

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.