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Genzyme manufacturing woes delay US Lumizyme approval
17 November 2009
Sue Sutter

Deficiencies at Genzyme's beleaguered Allston, Massachusetts manufacturing plant must be resolved before the US FDA will approve Lumizyme (alglucosidase alfa) for Pompe disease, the company said.
The FDA issued Genzyme its second complete response letter for Lumizyme on November 13th. The enzyme...



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