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US delay for Genzyme's new version of Myozyme

This article was originally published in Scrip

Executive Summary

Approval in the US of a new version ofGenzyme's established Pompe disease therapy Myozyme (alglucosidase alfa) has been delayed to allow the FDAto complete its review of the company's risk evaluation and mitigation strategy (REMS), which it submitted earlier this month, and to allow for time for the company and the FDA to agree on the design of a post-approval verification study.



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