Recon: Judge blocks CDC’s overhaul of childhood vaccines; FDA rejects Aldeyra’s eye disorder drug
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- NIH grant awards are again lagging far behind historical averages, analysis shows (STAT)
- Federal judge stalls health secretary RFK Jr.’s overhaul of vaccine policy (STAT)
- Pediatricians win Round 1 in vaccine fight, but damage has been done (Reuters)
- Asthma patients suffered as GSK pursued ‘egregious’ price hikes, senator says (STAT)
- White House digs in on ‘most-favored nation’ drug pricing despite Congress’ cool reception (STAT)
- US FDA declines to approve Aldeyra's eye disorder drug, shares slump (Reuters)
- Exclusive: China mRNA therapy startup Innorna to test gout treatment in US (Endpoints)
- MDR/IVDR Changes And A Question of Balance: EU’s Várhelyi On Device Safety And Innovation (MedTech Insight)
- Denmark Aims To Streamline First-In-Human Trials For Advanced Therapies (Pink Sheet)
- Valneva Asked To Strengthen Ixchiq Label After EMA’s Meningitis Signal Review (Pink Sheet)
- Roche, Nvidia will build pharma's largest 'AI factory,' eclipsing Lilly's supercomputer (Endpoints)
- Bicycle to cut 30% of staff after cancer drug's regulatory setback (Endpoints)
- Rhythm’s Imcivree fails Phase 3 for rare form of obesity as PDUFA date nears for larger indication (Endpoints)
- J&J pulls out of JLABS New York location as it shrinks incubator footprint (Endpoints)
- New renal disease biotech R1 Therapeutics nabs $77.5M for Phase 2b (Endpoints)
- BioMarin halts Phase 2 Voxzogo dosing in certain patients over safety concern (Endpoints)
- Lilly Gets Lone Sell From HSBC Ahead of Deeper Weight Loss Drug Price Cuts (Bloomberg)
- Alibaba AI Takes Aim at Silent Liver Epidemic (Bloomberg)
- Stryker attack raises concerns about role of device management tool (MedTech Dive)
- Alcon abandons effort to purchase LENSAR after FTC scrutiny (MedTech Dive)
- Vicarious Surgical applies for Nasdaq listing (MedTech Dive)
- AI Precision Testing Will Be Standard Of Care Within 5 Years, Says Waiv CEO After $33M Raise (MedTech Insight)
- BCI Maker Paradromics Builds Academic Network To Advance Brain-Computer Interface Research (MedTech Insight)
- Snack Brands Jockey to Invent the Next Hit Chip (Bloomberg)
- JBS workers go on strike at one of largest beef plants in the US (Food Dive)
- For decades, they’ve set the record straight in biology. Next up: science’s reproducibility crisis (STAT)
- Viridian’s Severe Thyroid Eye Disease Drug Veligrotug Among Latest EU Filings (Pink Sheet)
- The greatest threat to federally qualified health centers may not be federal funding cuts (STAT)
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