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Bio Products' Coagadex Gets CHMP OK After Fast Track Assessment

This article was originally published in Scrip

Executive Summary

Coagadex, Bio Products Laboratory Limited's purified coagulation Factor X concentrate derived from human plasma, got the greenlight Jan. 29 from the EU's top scientific advisory panel, the Committee for Medicinal Products for Human Use (CHMP), as the first replacement therapy for patients with hereditary Factor X deficiency, a rare inherited bleeding disorder, just over three months after the therapy won marketing approval in the US.

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