1. In Vivo

Satraplatin's Stumble: Is Accelerated Approval Under Threat?

It was a shocking summer for Germany's GPC Biotech, whose stock lost over 70% of its value in late July after an FDA advisory committee recommended that FDA delay considering prostate cancer candidate satraplatin for approval. Regulatory snafus are nothing new, but this story sends some clear messages to the industry.

It was a shocking summer for Germany’s GPC Biotech AG . The biotech’s stock lost more than 70% of its value in late July after an FDA advisory committee unanimously recommended that FDA delay considering prostate cancer candidate satraplatin for approval until overall survival data from the group’s 950-patient SPARC (satraplatin and prednisone against refractory cancer) trial is available.

As if that wasn’t enough, GPC was then slapped with a class action lawsuit from shareholders alleging that it lied...

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