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Merck Revives ‘Breakthrough’ Status For HCV Combo

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA told Merck it planned to rescind a ‘breakthrough’ designation for grazoprevir/elbasvir in genotype 1 HCV, but now has designated the combo in genotype 4 and in genotype 1 patients with end-stage renal disease.

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