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Novartis/Idenix HCV Studies Altered For GI Safety; Five Gleevec sNDAs Pending

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Idenix’ revision to the dosing scheme across its Phase IIb clinical program for valopicitabine reflects the firm’s and FDA’s concern that serious gastrointestinal side effects could represent key dose-limiting adverse events for the hepatitis C agent.

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