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BioPharmaceutical Clinical Trials Regulation

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

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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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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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