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)
- 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)
- 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)
- 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)
- 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)
- 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)
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