TOP NEWS
Essential Update: New Treatment Approaches for Late-Onset Pompe Disease
The AMDA is partnering with Medlive to bring this exciting program to HCPs in the Pompe community. Join leading experts Dr. Tahseen Mozaffar and Dr. Barbara Burton as they discuss late-onset Pompe disease (LOPD)A form of Pompe disease that begins after infancy and usually progresses more slowly.. Hear the latest advancements, including newly approved...
OTHER NEWS
Genzyme Submits All Information Requested by FDA for Lumizyme
CAMBRIDGE, Mass. – Genzyme Corporation (Nasdaq: GENZ) announced today that it has submitted the final documentation to address all items in the FDA’s complete response letter for LumizymeTM (alglucosidase alfaA form of enzyme replacement therapy used to treat Pompe disease by providing a lab-made version of the GAA enzyme.), produced at the 2,000 L bioreactor scale. The submission...
IPA Statement: The End of Myozyme Supply Restrictions
Dear IPA Affiliate, You will no doubt have heard the wonderful news that Myozyme from the Belgian production facility has been approved for patients within the European Community (see the IPA website for the press release). Another great success has been the adoption...
Pompe Program Update from Genzyme
Supply Update In January 2009, Genzyme notified the Pompe community that we were experiencing a temporary constraint in the global supply of Myozyme® (alglucosidase alfa) produced at the 2000 L bioreactor scale and that inventories were extremely tight. We are pleased...
Genzyme Receives Complete Response Letter from FDA on Lumizyme Application
CAMBRIDGE, Mass. – Genzyme Corporation (Nasdaq: GENZ) announced today that it has received a complete response letter from the FDA regarding its application to market Lumizyme™ (alglucosidase alfa) for the treatment of Pompe diseaseA rare genetic disease in which the body cannot properly break down glycogen, leading to buildup that damages muscles and can affect breathing and, in some cases, the heart.. In its letter, the agency outlines...
Amicus Therapeutics Suspends Enrollment for Phase 2 Clinical Trial of AT2220 for Pompe
Amicus Therapeutics announced today that the Company has suspended enrollment for the Phase 2 clinical trialA research study that tests new treatments or approaches in people. of its investigational drug AT2220 (1-deoxynojirimycin HCI) for the treatment of Pompe Disease and that it has received verbal notice from the U.S. Food and...
European Authorities Approve Larger-Scale Production of Genzyme’s Myozyme
CAMBRIDGE, Mass. – Genzyme Corporation (Nasdaq: GENZ) announced today that the European Commission has approved the production of Myozyme® (alglucosidase alfa) at the 4000 liter (L) bioreactor scale at its manufacturing facility in Geel, Belgium. The product will be...
Genzyme Receives Positive Opinion on Myozyme from CHMP
CAMBRIDGE, Mass. – Genzyme Corporation (Nasdaq: GENZ) announced today that the Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the company’s variation to produce Myozyme® (alglucosidase alfa) at the 4000 liter (L) bioreactor...
November 2008 Pompe Program Update 2
Genzyme Pompe Program Update- November 17, 2008 We would like to take this opportunity to provide an important update to the Pompe Community. The US Food and Drug Administration (FDA) has informed Genzyme that the FDA plans an accelerated approval for alglucosidase...
Myozyme Produced at the 2000 L Bioreactor Scale to Receive Accelerated Approval
Myozyme Produced at the 2000 L Bioreactor Scale to Receive Accelerated Approval
November 2008 Pompe Program Update
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,...
Acid Maltase Deficiency Association
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