FDA Agrees To Accelerated Approval For Myozyme Scale-Up, Genzyme Says
This article was originally published in The Pink Sheet Daily
Executive Summary
The 2,000L version of Myozyme on track for approval with a post-market confirmatory trial in February; user fee date extended while FDA reviews REMS submission.
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The hits just keep on coming for Genzyme. On a March 2 call with investors, the firm had to announce not just a "complete response" letter for its 2000-liter scale-up of Myozyme (which will be called Lumizyme for the larger production scale), but also that its Allston Landing manufacturing site had received a 483 report from FDA and a subsequent warning letter
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