Genzyme Program Update November 10th, 2008 Genzyme would like to take this opportunity to provide an update to the Pompe Community. The US Food and Drug Administration (FDA) held a meeting of its Endocrinologic and Metabolic Drugs Advisory Committee on October 21,...
Amicus Therapeutics Announces Positive Results From Two Phase 1 Clinical Studies of
MTAP Fact Sheet July 2007
MTAP FACT SHEET JUNE 2007
Myozyme® Temporary Access Program
Pompe Program Update May 2007 There are two studies to further evaluate Myozyme® (alglucosidase alfa) that will be conducted as part of Genzyme’s postmarketing commitments (PMC) to the FDA. A postmarketing commitment is an agreement between a regulatory agency and a...
Flying with a ventilator in the USA
GENZYME POMPE PROGRAM APRIL 2007
In an effort to complete the AGLU02704 study (Late-Onset Treatment Study, LOTS) as responsibly as possible, Genzyme has amended the study protocol to incorporate the use of an adaptive design. Genzyme utilized this method to help ensure a conclusive trial outcome in...
Expensive drug gives hope to rare disease sufferer