BioCentury
ARTICLE | Clinical News

Thyrogen thyrotropin alpha regulatory update

March 21, 2011 7:00 AM UTC

EMA's CHMP said Genzyme notified the committee that due to a manufacturing issue the biotech will only be able to meet about 45% of European demand for thyroid cancer treatment Thyrogen thyrotropin alfa until July. Genzyme said it identified a processing problem in a batch of Thyrogen intended for the European market prior to the fill/finish process at one of its manufacturing plants in Framingham, Mass. Genzyme added that the shortage will also affect U.S. supplies of Thyrogen from mid-April through mid-July. Genzyme said the issue did not occur at its newest plant in Framingham, Mass. ...