Recon: FDA approves Lilly’s GLP-1 pill Foundayo; White House announces 100% tariffs on some drugs

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

In Focus: US

• Makary marks one year at FDA with focus on achievements in speech to staff (STAT)
• Lilly gains after FDA approves weight-loss pill, sizing down investor doubts (Reuters)
• Trump administration prepares 100% tariffs on some imported drugs (STAT)
• Kennedy sidelining of US advisory panel delays updates to cancer screening guidelines (Reuters)
• US FDA clarifies policies on compounding of GLP-1 medicines (Reuters)
• Trump’s Obesity Drug Plan for Medicare Would Cost Insurers Billions (Bloomberg)

In Focus: International

• Poland, Romania must pay Pfizer $2.2B in fight over contested COVID vaccine doses: Belgian court (Fierce Pharma)
• China reports 219 cases of foot-and-mouth cattle disease in northwestern region (Reuters)
• Force Majeure, 35% Spike In Plastics Costs: Middle East Conflict Hits Medical Supply Chains (MedTech Insight)
• China Issues Global-First Approval For SPECT/CT Imaging Agent For Tumor Diagnosis (MedTech Insight)
• MFN: England’s HTA Appraisals ‘Hold Steady’ For Now (Pink Sheet)
• UK cost watchdog clears Novo's Wegovy for cardio risk reduction (Fierce Pharma)

Pharma & Biotech

• Novo claims that its obesity pill is better than Lilly’s. Only a head-to-head trial can prove it (Endpoints)
• Wall Street sees multi-billion dollar debut for Lilly's obesity pill despite Novo lead (Reuters)
• Immunovant's FcRn drug fails in a pair of Phase 3 trials in thyroid eye disease (Endpoints)
• Exclusive: OpenEvidence moves into prior authorization and prescriptions routing (Endpoints)
• Alto Neuroscience shelves schizophrenia cognitive impairment program after Phase 2 miss (Endpoints)
• Gilead ends a Phase 2/3 trial of long-acting HIV pills, following earlier clinical hold (Endpoints)
• AstraZeneca's liver cancer therapy combo slows disease progression in late-stage trial (Reuters)

Medtech

• Beyond detection: In the age of clinical AI, what counts as an FDA ‘breakthrough’ medical device? (STAT)
• ‘Cracks show’ as CDRH staff contend with heavy workloads (MedTech Dive)
• Merit Medical acquires View Point for $140M (MedTech Dive)
• J&J’s Impella heart pump shows no patient benefit in 2 trials (MedTech Dive)
• Distalmotion targets ASC robotic gynecology programs with FDA filing (MedTech Dive)
• Industry Underprepared for QMSR Launch, Survey Finds (MedTech Insight)

Food & Nutrition

• How AI is changing food supply chains (Food Dive)
• Food industry moves toward transparency with smarter barcodes (Food Dive)

Government, Regulatory & Legal

• Exclusive: US nicotine pouch fast-track scheme slowed by worries over youth, new users (Reuters)
• US MFN Policies Are Driving The Need For Better RWE (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.