Recon: FDA to reconsider Atara, Pierre Fabre drug after surprise rejection; Amazon to stock Ozempic at US kiosks

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

In Focus: US

What was lost at the FDA (STAT)
FDA to reconsider treatment for rare cancer after its surprise rejection (STAT)
Amazon to carry Ozempic at US kiosks, offer same-day delivery (Reuters)
Trump administration’s drug strategy is at odds with recent actions on funding, policy (STAT)
Amgen, AbbVie say IRA negotiations impacted Q1 sales (Endpoints)
“Sounds Great. Do You Want FDA Approval?” A Regulatory Analysis of Psychedelics (FDA Law Blog)

In Focus: International

Novo and Lilly gain on signs weight-loss pills could expand the market (Reuters)
Cruise ship hantavirus outbreak worries experts, though they discount pandemic fears (STAT)
Countries scramble to track passengers of virus-hit cruise ship (Reuters)
Siemens Healthineers cuts 2026 outlook on Chinese market woes (Reuters)
Global crackdown on illicit pharmaceuticals sees $15.5 million in seizures (Reuters)
Medtech AI Act Simplification Push Fails At Last Hurdle (MedTech Insight)
Safety Not A Trade-Off For Innovation In MDR, Says Commission’s Giorgio (MedTech Insight)

Pharma & Biotech

Next-gen Duchenne drug from Entrada disappoints (STAT)
Lilly allots $4.5B for new manufacturing projects across Indiana (Endpoints)
Angelini Pharma buys Catalyst Pharmaceuticals and its rare disease drugs for $4.1B (STAT)
Sanofi asks to pull diabetes drug out of FDA voucher program after political appointee interfered with review (STAT)
Kenvue beats first-quarter estimates amid pending acquisition by Kimberly-Clark (Reuters)
Zealand unveils buyback, Roche payments; shares rise (Reuters)
Promising Revolution Medicines pancreatic cancer drug has high rate of mostly manageable side effects (Reuters)
BeOne culls five cancer programs and an autoimmune Phase 2 (Endpoints)
Lonza looks to ride ADC wave with upcoming factory, workforce expansion (Endpoints)
Exclusive: Startup aims to lift mRNA out of purgatory with more durable therapies (Endpoints)

Medtech

Becton Dickinson raises annual profit forecast on strength in drug delivery devices (Reuters)
FDA warns of neurosurgical supply disruptions (MedTech Dive)
Neptune Medical’s GI robot succeeds in colonoscopy study (MedTech Dive)
Integra reappoints Stuart Essig as CEO (MedTech Dive)
Insulet raises revenue expectations for 2026 (MedTech Dive)
J&J’s Ottava robot meets goals in gastric bypass study (MedTech Dive)
Solventum Bets On 20 Product Launches To Power Post-3M Growth (MedTech Insight)
Roche To Acquire PathAI, Signaling Intensifying AI Diagnostics Race (MedTech Insight)
Breakthrough Devices Bring New Flexibility And Scrutiny For Notified Bodies (MedTech Insight)

Food & Nutrition

How surging gas prices are impacting grocery (Food Dive)
DOJ confirms antitrust investigation into top beef producers (Food Dive)

Government, Regulatory & Legal

Pennsylvania sues AI chatbot company for posing as a licensed doctor (Endpoints)

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.