Spectrum Pharma Investors Sue Over Rejected FDA Advice

By Melissa Daniels (February 23, 2017, 7:58 PM EST) -- Officers and directors at Spectrum Pharmaceuticals Inc. were hit with a shareholder derivative action in Delaware federal court on Thursday alleging they harmed investors and the company with a new drug application for a bladder cancer treatment drug filed in defiance of U.S. Food and Drug Administration advice. 

The FDA had warned Spectrum not to file a new drug application for Apaziquone using data from two clinical studies that regulators said didn't provide satisfactory data, the complaint said. But Spectrum in December 2015 submitted an NDA for the drug that included a post-hoc analysis of pooled data from the clinical studies...

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