Jan 14, 2009 | NEWS
Since the first market approval of MyozymeA form of enzyme replacement therapy used to treat Pompe disease by providing a lab-made version of the GAA enzyme., the IPA has liaised directly with Genzyme LSDA group of diseases in which substances build up inside...
Jan 14, 2009 | NEWS
Since the first market approval of Myozyme, the IPA has liaised directly with Genzyme LSD Therapeutics to insist that an adequate inventory of the product was kept to ensure continuous supply to all patients receiving the treatment; whether through their commercial or...
Jan 13, 2009 | NEWS
This guidance is being distributed to all treating physicians worldwide except those in the European Union (EU). Separate guidance will be sent to European healthcare professionals in accordance with the requirements of the European Medicines Agency (EMEA); we expect...
Jan 1, 2009 | NEWS
We would like to take this opportunity to provide an important update to the Pompe Community. Background In the early stages of development of Myozyme® (alglucosidase alfa), Genzyme initiated manufacturing at the 160 liter (L) scale, and has since scaled-up the...
Jan 1, 2009 | NEWS
We would like to take this opportunity to provide an important update to the global Pompe Community. Background In the early stages of development of Myozyme® (alglucosidase alfa), Genzyme initiated manufacturing at a small scale, and has since scaled-up the process...
Nov 17, 2008 | NEWS
The US Food and Drug Administration (FDA) has informed Genzyme that the FDA plans an accelerated approval for alglucosidase alfa produced at the 2000 L bioreactor scale for the treatment of late onset Pompe diseaseA form of Pompe disease that begins after infancy and...
Nov 10, 2008 | NEWS
The US Food and Drug Administration (FDA) held a meeting of its Endocrinologic and Metabolic Drugs Advisory Committee on October 21, 2008 to discuss Genzyme’s Biologics License Application (BLA) for alglucosidase alfa produced at the 2000 L bioreactor scale to treat...
Jun 4, 2008 | NEWS
Amicus Therapeutics, a biopharmaceutical company developing small molecule, orally-administered pharmacological chaperones for the treatment of human genetic diseases, today announced that it has initiated a Phase 2 clinical trialA research study that tests new...
Apr 21, 2008 | NEWS
We would like to take this opportunity to provide an important update related to Myozyme (alglucosidase alfa) manufacturing in the United States. The FDA has informed Genzyme of its decision on the application for the larger scale manufacturing process to...
Jan 15, 2008 | NEWS
In April 2007, Genzyme implemented measures to manage the limited supply of Myozyme® (alglucosidase alfa) in the United States in order to ensure uninterrupted treatment for as many patients as possible. Since April, both the patient and physician communities have...
