May 22, 2009 | NEWS
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...
May 8, 2009 | EDITORIALS
By: IPA posted on: May 08, 2009 Dear IPA Affiliate, You will no doubt have heard the wonderful news that MyozymeA form of enzyme replacement therapy used to treat Pompe disease by providing a lab-made version of ... More from the Belgian production facility has been...
May 8, 2009 | NEWS
Dear IPA Affiliate, You will no doubt have heard the wonderful news that MyozymeA form of enzyme replacement therapy used to treat Pompe disease by providing a lab-made version of ... More from the Belgian production facility has been approved for patients within the...
Mar 3, 2009 | NEWS
Supply Update In January 2009, Genzyme notified the Pompe community that we were experiencing a temporary constraint in the global supply of Myozyme® (alglucosidase alfaA form of enzyme replacement therapy used to treat Pompe disease by providing a lab-made version of...
Mar 2, 2009 | NEWS
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 alfaA form of enzyme replacement therapy used to treat Pompe disease by...
Feb 27, 2009 | NEWS
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. More of its investigational drug AT2220 (1-deoxynojirimycin HCI) for the treatment of Pompe...
Feb 26, 2009 | NEWS
CAMBRIDGE, Mass. – Genzyme Corporation (Nasdaq: GENZ) announced today that the European Commission has approved the production of Myozyme® (alglucosidase alfaA form of enzyme replacement therapy used to treat Pompe disease by providing a lab-made version of ... More)...
Feb 19, 2009 | NEWS
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 alfaA form of enzyme replacement therapy...
Feb 4, 2009 | NEWS
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...
Feb 4, 2009 | NEWS
MyozymeA form of enzyme replacement therapy used to treat Pompe disease by providing a lab-made version of ... More Produced at the 2000 L Bioreactor Scale to Receive Accelerated...
