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

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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