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Japan’s Ministry of Health, Labour and Welfare has approved Biocon’s insulin glargine, the eighth biosimilar backed by the regulator since 2009. Read More
Eagle Pharmaceuticals is objecting to the FDA’s decision to grant orphan drug Bendeka only three years of exclusivity instead of the full seven years and says it may take action. Read More
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