Recon: Pfizer’s experimental therapy falters in lung cancer study; European patient access to new drugs worsens

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

In Focus: US

• All US passengers from hantavirus-hit ship return to home states (Reuters)
• US FDA updates guidance to speed up drug development (Reuters)
• Whistleblower suit accuses Genentech, Novartis of running decades-long kickback scheme on allergy med Xolair (Fierce Pharma)
• US to investigate Germany's proposed drug spending reforms (Fierce Pharma)

In Focus: International

• Gene-editing startup launches with $230 million and a Chinese licensing deal (STAT)
• Europe must rethink medicine pricing or risk losing investments, pharma lobby chief says (Reuters)
• European patient access to new drugs worsens, pharma lobby says (Reuters)
• China closing in but US leads in biotech quality, commercial reach, survey finds (Reuters)
• Regulatory tracker: Pierre Fabre expands Braftovi’s European label to first-line colorectal cancer (Fierce Pharma)

Pharma & Biotech

• Eli Lilly gave extraordinary obesity drug access to a 79-year-old patient. Who was it? (STAT)
• Cadence raises $100 million to automate chronic disease care with regulated AI (STAT)
• Closely watched Pfizer lung cancer drug falls short in clinical trial (STAT)
• FDA to launch pilot program to speed up early-stage clinical trials (STAT)
• Sangamo’s three-decade run comes to a close as Lilly and Astellas eye assets (Endpoints)
• Boundless Bio's reverse merger; CARsgen wins first solid tumor approval for CAR-T (Endpoints)

Medtech

• Karl Storz laying off employees in North Carolina amid robotics strategy shift (MedTech Dive)
• Medtronic appoints veteran J&J exec as first CFO of innovation (MedTech Dive)
• India Considers Letting Hospitals Bypass Import Rules For High-End Medical Equipment, Faces Pushback (MedTech Insight)
• UK MHRA’s Global Device Ambitions Extend To Two-Way Reliance (MedTech Insight)

Food & Nutrition

• Restaurant inspection data may help strengthen foodborne illness prevention (Food Safety News)
• Why factory farms are a major threat to food safety (Food Safety News)

Government, Regulatory & Legal

• Small Sleep Sacks, Big Compliance Lessons: What FDA’s Happiest Baby Warning Letter Means for Device Manufacturers (FDA Law Blog)
• Acadia’s Daybu Faces Second Shot At EU Approval After EMA Re-Examination (Pink Sheet)
• Health Canada Offers Clinical Trial Sponsors A No-Fault Head Start On E6(R3) Compliance (Pink Sheet)
• Once-Weekly Insulin Race Heats Up As Lilly Awaits EU Verdict On Efsitora (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.