FDA forces Concert Pharma to hit the brakes on a mid-stage study so it can review tox studies
Concert Pharmaceuticals has been slammed with a clinical hold on a Phase IIa study of its drug CTP-543 for alopecia areata.
The biotech made it sound innocent enough. The FDA, it says, needs to review “certain recently completed non-clinical toxicology studies.” The agency did not cite a safety concern, Concert added in a brief statement, and regulators wanted to review the data to support its plans for a one-year dosing schedule of their new version of Jakafi.
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