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California-based Amgen may soon be the first to get a new class of cholesterol-lowering biologics onto the European market, following a positive opinion from the European Medicines Agency on Friday. Read More
Janssen Pharmaceuticals plans to make its long-acting atypical schizophrenia therapy Invega Trinza commercially available by mid-June, following FDA approval Monday. Read More
The FDA has issued draft guidance spelling out in detail how to prepare and submit an IND if the sponsor is an investigator and not a commercial entity — saying sponsor-investigators often lack the regulatory know-how to submit a proper IND. Read More
Ranbaxy is being accused in federal court of filing ANDAs with false documentation in an effort to block generic competitors from coming to market. Read More