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Regulatory Briefs: Pradaxa’s New Indication, Lemtrada Resubmitted, New Hep C Drugs Under Review

Executive Summary

Boehringer’s anticoagulant Pradaxa adds DVT/PE claim, coming closer to labeling parity with market leader Xarelto; Bristol gets in on the race for new oral hepatitis C drugs with daclatasvir/asunaprevir filings; Genzyme reaches agreement with FDA on resubmission plan for Lemtrada; and Alkermes prepares to file its long-acting aripiprazole lauroxil.

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