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Genzyme Study of Myozyme® for Late-Onset Pompe Patients Meets Co-Primary Efficacy Endpoints
Genzyme Study of Myozyme® for Late-Onset Pompe Patients Meets Co-Primary Efficacy Endpoints
AMICUS THERAPEUTICS COMMENCES PHASE 1 CLINICAL TRIALS FOR AT2220 FOR POMPE DISEASE
Cranbury, NJ, DECEMBER 14, 2006 – Amicus Therapeutics, a biopharmaceutical company developing small molecule, orally-administered pharmacological chaperones for the treatment of human genetic diseases, today announced that it has commenced Phase 1 clinical trials for...
European Commission Approves Genzyme’s Myozyme®
Date: April 3, 2006 Product is First Treatment for Pompe Disease Genzyme Corp. (Nasdaq: GENZ) announced today that it has received marketing authorization for Myozyme® (alglucosidase alfa) in the European Union. Myozyme has been approved for long-term enzyme...
Genzyme Provides Update on U.S. Marketing Application for Myozyme®
Date: January 17, 2006 Genzyme Corp. (Nasdaq: GENZ) announced today that the Food and Drug Administration has extended by 90 days the review period for the biologics license application for Myozyme® (alglucosidase alfa). The new action date for the application is...
Myozyme® Receives Positive Opinion from European Regulatory Committee
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...
Genzyme Begins Trial of Myozyme® for Patients with Late-Onset Pompe Disease
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...
Genzyme Submits BLA for Myozyme® for Treatment of Pompe Disease
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...
Pompe Program Update July 2005
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 study...
Pompe Program Update December 2004
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....
Genzyme Files for European Approval of Myozyme For Treatment of Pompe Disease
Genzyme Files for European Approval of Myozyme For Treatment of Pompe Disease Date: December 20, 2004 Genzyme Corp. (Nasdaq: GENZ) announced today that the European Medicines Agency (EMEA) has accepted its marketing authorization application for Myozyme...