Oct 1, 2009 | NEWS
CRANBURY, N.J., Sept 30, 2009 – – Amicus Therapeutics today announced it plans to initiate a Phase 1 study of AT2220 (1-deoxynojirimycin HCl), its investigational drug in development for the treatment of Pompe Disease. The primary objective of this study...
Jul 23, 2009 | NEWS
In their second quarter earning statement, Genzyme provided an update on the situation at the Allston manufacturing plant, and the US Lumizyme application. To read full statement, please click here.
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 alfa), produced at the 2,000 L bioreactor scale. The submission...
May 8, 2009 | NEWS
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...
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 alfa) produced at the 2000 L bioreactor scale and that inventories were extremely tight. We are pleased...
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 alfa) for the treatment of Pompe disease. In its letter, the agency outlines...
Feb 27, 2009 | NEWS
Amicus Therapeutics announced today that the Company has suspended enrollment for the Phase 2 clinical trial 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...
Feb 26, 2009 | NEWS
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...
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 alfa) at the 4000 liter (L) bioreactor...
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...
