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BioPharmaceutical United States Regulation

Bye, Bye ‘Breakthrough’: Bristol, Merck HCV Drugs Face Loss Of Special Designation

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Executive Summary

Recent approvals of hepatitis C treatments Sovaldi, Harvoni and Viekira Pak lead agency to reconsider ‘breakthrough’-worthiness of Bristol’s daclatasvir and Merck’s doublet therapy. FDA’s willingness to rescind shows the risk sponsors face in trying to retain the designation as other competitors reach market.

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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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