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Genzyme's new Myozyme formulation wins FDA panel backing

This article was originally published in Scrip

Executive Summary

A US FDAadvisory panel has endorsed approval of a new version of Genzyme's established Pompe disease therapy Myozyme (alglucosidase alfa) that is produced on a larger manufacturing scale and indicated for late-onset disease. The formulation, which is already licensed in more than 40 countries, would enable Genzyme to boost US sales because its current manufacturing capacity is not able to meet adult patient demand for the biological.



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