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August 7, 2025
by Jason Scott

Recon: Lilly's weight loss pill shows disappointing results; FDA moves to boost US drug manufacturing

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

In Focus: US
  • As mRNA falls out of favor for HHS, are cancer vaccines next? (STAT)
  • Work on mRNA therapies was surging. Now Kennedy has rocked the field (STAT)
  • US FDA announces new program to boost domestic drug manufacturing (Reuters)
  • US FDA Requires Opioid Class Labeling Changes Despite Adcomm Advice (Pink Sheet)
  • US FDA Skips User Fee Increase For More Staff Amid Exodus, Hiring Difficulties (Pink Sheet)
  • Some Common Medications Have a Little-Known Side Effect (Bloomberg)
  • Trump, pharma industry discuss boosting medicine spending abroad to cut US prices, sources say (Reuters)
In Focus: International                                                                                                       
  • Danish drugmakers jump as Eli Lilly's weight-loss pill data disappoints (Reuters) (Bloomberg)
  • Chinese biotech Minghui raises $131M to advance its PD-1xVEGF bispecific (Endpoints)
  • Titanium Dioxide Stays: EU Decides Not To Pull Plug On Widely Used Excipient (Pink Sheet)
  • England: Pharma Firms To Benefit From Parallel HTA And Regulatory Pathway (Pink Sheet)
  • Merck KGaA Is Latest Drugmaker to Weigh Direct US Patient Sales (Bloomberg)
Pharma & Biotech
  • Alnylam could be the next mega-cap biotech (STAT)
  • Eli Lilly’s much-anticipated obesity pill yields modest results (STAT) (Reuters)
  • Superagers’ brains offer clues to cognitive resilience, and possible treatments, researchers say (STAT)
  • Lithium, a treatment for bipolar disorders, might be a key to Alzheimer’s disease (STAT)
  • Xanax-maker Viatris beats quarterly profit, revenue estimates; shares rise (Reuters)
  • Sarepta hired a Trump-connected firm to lobby on Duchenne treatment (STAT)
  • Scholar Rock expects September PDUFA for spinal muscular atrophy drug to stay unchanged despite CDMO woes (Endpoints)
  • Exclusive: Translucent raises $7M for AI to analyze financial performance (Endpoints)
  • FDA lifts pause of Valneva's chikungunya vaccine in older adults (Fierce Pharma)
Medtech
  • The companies that pledged to build patient AI assistant apps (STAT)
  • FTC moves to block Edwards’ JenaValve acquisition (MedTech Dive)
  • BD commits $35M to expand US syringe production plant (MedTech Dive)
  • Zimmer Biomet raises annual profit forecast on lower tariff impact (Reuters)
  • PathAI Talks PCCPs: ‘Accelerated Software Updates, Saves Time And Money’ (MedTech Insight)
  • SpotitEarly Sets Up US HQ, Launches Trials For Dog- And AI-Powered Early Cancer Detection Test (MedTech Insight)
  • Additional Death And Injuries Added To 2024 Philips Ventilator Recall (MedTech Insight)
  • Insulet beats second-quarter profit estimates on strong demand for insulin pumps (Reuters)
Food & Nutrition
  • Ultra-Processed Foods Make Up More Than 60% of US Kids’ Diets (Bloomberg)
  • Raw milk tied to over 21 illness cases in Florida: Here's why (The Hill)
Government, Regulatory & Legal  
  • Wyden, Warren launch investigation into UnitedHealth’s nursing home practices (STAT)
  • CDC adopts advisors' recommendation for Merck’s infant RSV antibody (Endpoints)
  • Planned Parenthood to close Louisiana clinics (The Hill
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.
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