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- Rare-disease biotech coalition urges Trump admin to carve out orphan drugs from Medicare price-cut pilotsBiotech firms formed the Rare Disease Company Coalition and met with the White House Office of Management and Budget to discuss excluding orphan drugs from two Medicare price‑cut pilot programs. T…
- FDA issues warning letters for CGMP breaches and inadequate trial consent, EU releases AI transparency guidelinesThe U.S. Food and Drug Administration sent warning letters to several drug manufacturers for not meeting current good manufacturing practice requirements. One firm was also cited for failing to pr…