Jun 27, 2007 | NEWS
MTAP, the Myozyme® (alglucosidase alfa) Temporary Access Program, is a clinical program to provide access to Myozyme produced by a larger scale manufacturing process for a limited time until this manufacturing scale is approved by the FDA. Patients enrolled in MTAP...
Jun 27, 2007 | NEWS
Genzyme would like to take this opportunity to provide a brief update to the Pompe patient community regarding the US supply of Myozyme® (alglucosidase alfa). As planned, Genzyme submitted the necessary documentation to the FDA this month for the licensure of the...
May 2, 2007 | NEWS
MTAP, the Myozyme® (alglucosidase alfa) Temporary Access Program, is a clinical program to provide access to Myozyme produced by a larger scale manufacturing process for a limited time until this manufacturing scale is approved by the FDA. Patients enrolled in MTAP...
Apr 24, 2007 | NEWS
As many of you are aware, a standard part of the biologics drug development process is to incrementally scale-up manufacturing capacity as demand for the product increases. During the development of Myozyme®, Genzyme began the manufacturing process using a smaller...
Jun 8, 2006 | NEWS
Dear IPA members, Pompe patients, family members and GSD-net participants, The IPA board received several questions concerning participation in the LOTS trial. As there are certain restrictions to the market approval of Myozyme we asked Genzyme to make a written...
Apr 29, 2006 | NEWS
Genzyme Corp. (Nasdaq: GENZ) announced today that the Food and Drug Administration has granted marketing approval for Myozyme® (alglucosidase alfa) in the United States. Myozyme has been approved for the treatment of patients with Pompe disease, a debilitating,...
Apr 4, 2006 | NEWS
Product is First Treatment for Pompe Disease Genzyme Corp. (Nasdaq: GENZ) announced today that it has received marketing authorization for Myozyme® (alglucosidase alfa) in the European Union. Myozyme has been approved for long-term enzyme replacement therapy in...
Jan 18, 2006 | NEWS
Genzyme Corp. (Nasdaq: GENZ) announced today that the Food and Drug Administration has extended by 90 days the review period for the biologics license application for Myozyme® (alglucosidase alfa). The new action date for the application is April 28, 2006. The purpose...
Oct 2, 2005 | NEWS
The IPA has developed the Pompe connections brochure to help get patients and their families timely and relevant information about Pompe disease and the developments that are happening. Please visit the Pompe Connections Brochure page.
Jul 30, 2005 | NEWS
Genzyme Corp. (Nasdaq: GENZ) announced today that it has submitted a biologics license application (BLA) to the U.S. Food and Drug Administration for Myozyme® (alglucosidase alfa). If approved, Myozyme would be the first treatment developed for patients with Pompe...
