Genzyme Manufacturing Update Genzyme invites all patients to participate in a forum to discuss recent FDA reports and media attention related to manufacturing operations in Allston, Massachusetts. Date: Monday, November 23, 2009 Time: 6:00 PM – 7:00 PM (EST) US Toll...

Genzyme would like to provide an update to the US Pompe community about the status of the application for Lumizyme™ (alglucosidase alfaA form of enzyme replacement therapy used to treat Pompe disease by providing a lab-made version of ... More) produced at the 2000 L scale in the United States. To read full Program Update, please click here.

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 DiseaseA rare genetic disease in which the body cannot properly break down glycogen, leading to buildup tha... More. The primary objective of this study is to...

In their second quarter earning statement, Genzyme provided an update on the situation at the Allston manufacturing plant, and the US LumizymeA form of enzyme replacement therapy used to treat Pompe disease by providing a lab-made version of ... More application. To read full statement, please click here.

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 ... More), produced at the 2,000 L bioreactor scale. The submission...

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 European Community (see the IPA website for the press release). Another great success has been the adoption...

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 ... More) produced at the 2000 L bioreactor scale and that inventories were extremely tight. We are pleased...

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 providing a lab-made version of ... More) for the treatment of Pompe diseaseA rare genetic disease in which the body cannot properly break down glycogen, leading to buildup tha... More. In its letter, the agency outlines...

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 DiseaseA rare genetic disease in which the body cannot properly break down glycogen, leading to buildup tha... More and that it has received verbal notice from the U.S. Food and...

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) at the 4000 liter (L) bioreactor scale at its manufacturing facility in Geel, Belgium. The product will be...

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 used to treat Pompe disease by providing a lab-made version of ... More) at the 4000 liter (L) bioreactor...

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...

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 Approval

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,...

New video added to “Meet the Patients”

A compilation of the most pertinent information regarding the MyozymeA form of enzyme replacement therapy used to treat Pompe disease by providing a lab-made version of ... More supply issue. The IPA has done its best to gather the most relevant and commonly asked questions regarding this matter. Please download the pdf file. Download complete article

The AMDA is writing to our Pompe patient community to let everyone know that the AMDA has been working closely with the IPA and Genzyme in order to get communication out to our patient population about the status of the MyozymeA form of enzyme replacement therapy used to treat Pompe disease by providing a lab-made version of ... More supply issue. Download complete...