Feb 4, 2009 | NEWS
Myozyme Produced at the 2000 L Bioreactor Scale to Receive Accelerated Approval
Feb 4, 2009 | NEWS
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,...
Feb 4, 2009 | NEWS
New video added to “Meet the Patients”
Jan 18, 2009 | NEWS
A compilation of the most pertinent information regarding the Myozyme 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...
Jan 17, 2009 | NEWS
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 Myozyme supply issue. Download complete...
Jan 16, 2009 | NEWS
The European Medicines Agency’s (EMEA) Committee for Medicinal Products (CHMP) has recommended that infants, children and adolescents be given priority access to Myozyme (alglucosidase alfa), from Genzyme, during the expected supply shortage of the medicine over the...
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 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...
