Recon: FDA releases draft guidance on gen AI-enabled devices; Industry warns Germany must reform drug pricing

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

In Focus: US

• FDA seeks public feedback to inform regulatory approach for generative AI-enabled medical devices (FDA)
• J&J’s Monarch robot wins FDA nod for AI features (MedTech Dive)
• FDA names second participant in TEMPO digital health pilot (MedTech Dive)
• FDA drug inspections return to pre-pandemic levels; Domestic OIA citations exceed global average (Pink Sheet)
• FDA drug repurposing pathway will drive research but faces many challenges (Pink Sheet)

In Focus: International

• Germany must reform drug pricing or risk losing pharma investment, industry warns (Pink Sheet) (Endpoints)
• Healthy volunteer studies only: UK limits eligibility for speedy Phase 1 trial approvals (Pink Sheet)
• Companies leaving UK Code of Practice to remain liable for pending cases (Pink Sheet)
• Third death in China's popular but opaque trials revealed, this time in CAR-T (Endpoints)
• India directs IND route for drugs without global approval running local phase 3 trials (Pink Sheet)
• Brazil aims to smooth road to advanced therapy GMP certification (Pink Sheet)
• Are biosimilars, price masking the answer to Europe’s problems amid US MFN policy? (Pink Sheet)

Pharma & Biotech

• Sanofi to lay off 229 Blueprint Medicines staffers, close Cambridge offices following acquisition (Fierce Pharma)
• Amylyx declares late-stage win with a GLP-1 antagonist in its post-ALS reset (Endpoints) (STAT)
• Leo Pharma to license Tanabe’s rare disease drug for pain with sun exposure (Endpoints)
• LEO Pharma buys worldwide dersimelagon rights for up to $435 million (Reuters)
• Regeneron ends eye disease study due to antibody’s safety profile (BioSpace)
• Rebounding biotech funds expected to spur CDMO growth within year (BioSpace)
• CMI adopts orphan drug field with dedicated center of excellence (Fierce Pharma)
• BMS’ Zenbexus approval is a myeloma milestone for minimal residual disease (Pink Sheet)
• Prominent AI startup rolls out virtual cell model in race to speed up science (STAT)

Medtech

• Mira fertility monitor’s ad claims of superiority withdrawn on Clearblue marketer P&G’s challenge (Medtech Insight) (Fierce Pharma)
• Samsung Galaxy Buds join Apple AirPods in FDA-cleared OTC hearing aid category (Medtech Insight)
• Cook Medical phishing, Baylor Genetics breach deepen medtech cybersecurity concerns (Medtech Insight)
• Coloplast expects Kerecis wound-care unit to return to growth in 2027, CFO says (Reuters)
• Medtronic bets its surgical AI future on Compute, not just the Hugo robot (Medtech Insight)

Food & Nutrition

• How cyclospora evaded the US food safety system to sicken thousands (New York Times)
• FDA classifies egg recall as class I, for highest health risk (New York Times)
• Doritos as farm-to-table snacks? Big Food, under duress, gets creative (STAT)

Government & Legal

• CDC’s new director is pressed to do something about its zombie programs (AP News)
• US school vaccination rates inch down yet again and exemptions reach record high (AP News)

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.