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The European Commission has granted orphan drug designation to fosbretabulin for the treatment of gastro-entero-pancreatic neuroendocrine tumors. Read More
The FDA slapped pharmaceutical manufacturer and repackager Safecor Health with a 13-item Form 483 citing lapses in quality control, batch specification and written procedures. Read More
A federal jury ruled that Gilead Sciences must dole out $200 million in damages to Merck and Ionis Pharmaceuticals for patent infringement over the active ingredient sofosbuvir in Gilead’s blockbuster hepatitis C drugs. Read More
There is a strong correlation between a surge in warning letters over data integrity issues and increased FDA inspections of manufacturers in India and China — one that could cause production headaches for U.S. drugmakers partnering with these facilities. Read More