Shire gets CHMP nod for US Vpriv manufacturing facility
This article was originally published in Scrip
Executive Summary
Shire has received a positive opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP) for the production of Vpriv (velaglucerase alfa) in its new, state-of-the-art manufacturing facility in Lexington, Massachusetts. Shire has been granted an expedited review, and expects a final decision from the European Commission soon. A US decision is expected in the first half of 2012.