Recon: FDA approves Regeneron’s hearing loss gene therapy; Novo’s oral diabetes drug reduced blood sugar in children in Phase 3a study

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

In Focus: US

Publicly, Kennedy embraces a more moderate MAHA (STAT)
Kennedy’s new silence on vaccines is political — and it won’t last (STAT)
Regeneron wins FDA approval for first gene therapy for genetic hearing loss (Reuters)
FDA declines Grace's stroke drug over manufacturing and packaging issues, shares slump (Reuters)
The Godmother of Silicon Valley is helping launch an AI healthcare residency program (Endpoints)
AbbVie's $1.4B North Carolina manufacturing site to finish during Trump's term (Endpoints)
US to loosen marijuana rules in major shift for $47 billion industry (Reuters)
White House to announce drug pricing deal with Regeneron, source says (Reuters)
What Does DOJ’s New Corporate Enforcement Policy Mean for the FDA- and DEA-Regulated Industry? (FDA Law Blog)

In Focus: International

UK investigates after big health dataset listed for sale on China's Alibaba (Reuters)
Fast-spreading measles outbreak has killed at least 30 in Bangladesh, WHO says (Reuters)
Deadly meningitis spreads as Sudanese refugees pack Chad camps, MSF says (Reuters)
Germany’s Higher Drug Rebates Would Send ‘The Wrong Message’ To Pharma (Pink Sheet)
Novo Nordisk's diabetes pill cuts blood sugar in key trial in children (Reuters)

Pharma & Biotech

In early trial, CAR-T results raise hope of preventing multiple myeloma in high-risk patients (STAT)
Can Erasca be biotech’s next big thing? We’ll see (STAT)
David Reese to retire from Amgen (Endpoints)
Exclusive: Gravity Rail raises $2.75M for customizable AI to communicate with patients (Endpoints)
Updated: Roche says its investigational breast cancer pill could outsell Herceptin (Endpoints)
Roche sales down 5% as currency effects outweigh gains for haemophilia drug (Reuters)
OpenAI's head of health lays out the AI giant’s healthcare ambitions (Endpoints)
Sanofi's solid earnings set stage for new CEO after drug trial 'setbacks' (Reuters)

Medtech

CMS, FDA team up to fast-track reimbursement for breakthrough devices (STAT)
Boston Scientific slashes 2026 guidance (MedTech Dive)
Tandem recalls Mobi insulin pumps over software malfunction (MedTech Dive)
CDRH Director Tarver previews AI guidance at AAMI event (MedTech Dive)
Intuitive Surgical lifts 2026 outlook for da Vinci robot procedure growth (MedTech Dive)
Apple fends off Masimo challenge to Apple Watch redesign (MedTech Dive)
IMDRF AI Framework Could Alter Cost Of Compliance (MedTech Insight)
Feeding Pump That Grew From A Father’s Mission Receives FDA Clearance (MedTech Insight)
Danaher Signals M&A Capacity For More Deals Even As $9.9Bn Masimo Integration Begins (MedTech Insight)

Food & Nutrition

Quality vs quantity: Food makers face tradeoffs when choosing protein source (Food Dive)
Little voluntary movement by companies to remove artificial food dyes spurs action by Consumer Reports (Food Safety News)

Government, Regulatory & Legal

Danaher reaches $172.5 million settlement with shareholders over post-pandemic outlook (Reuters)
Will bargain-basement telehealth visits help pharma drive drug scripts? (STAT)
US FTC settles case against anesthesia company (Reuters)
Dropping the flu vaccine requirement puts U.S. military readiness at risk (STAT)
Former tobacco executive joins CDC senior leadership, raising concerns over industry influence (STAT)
Trump reclassifies state-licensed medical marijuana as a less-dangerous drug in a historic shift (STAT)
Insurers refuse to join Medicare pilot offering weight loss drugs to seniors at steep discount (STAT)
Federal test of AI prior authorization is delaying care for seniors, report says (STAT)

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.