by United Pompe | Jan 18, 2016 | News
Date: January 27, 2006 Proposed Indication Includes All Patients with Pompe Disease Genzyme Corp. (Nasdaq: GENZ) announced today that the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency has adopted a positive opinion on the marketing...
by United Pompe | Jan 18, 2016 | News
Date: September 15, 2005 Genzyme Corp. (Nasdaq: GENZ) announced today that it has initiated a clinical trial evaluating the safety and efficacy of Myozyme® (alglucosidase alfa) in patients with late-onset Pompe disease. The trial is designed to provide additional...
by United Pompe | Jan 18, 2016 | News
Date: July 29, 2005 Pivotal Trial Meets Primary Endpoint 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...
by United Pompe | Jan 18, 2016 | News
Pompe Program Update July 2005 Steady progress is being made in all areas of the Genzyme Pompe program and the goal of obtaining worldwide regulatory approval for the investigational rhGAA enzyme remains one of Genzyme’s highest priorities. The screening...
by United Pompe | Jan 18, 2016 | News
Pompe Program Update December 2004 Genzyme is still on track for the Marketing Authorisation Application (MAA) filing in December with the European regulatory authorities, and they will issue a corporate press release once the filing has been formally accepted....
