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Rationing Of Genzyme’s Myozyme In Europe Likely Through April Due To Supply Constraints

This article was originally published in The Pink Sheet Daily

Executive Summary

Until approval of the larger 4000 L bioreactor for the Pompe Disease product, EMEA recommends priority access for infants, children and adolescents.

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Genzyme Receives Complete Response, Warning Letters For Lumizyme

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

Genzyme Receives Complete Response, Warning Letters For Lumizyme

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

Genzyme Receives Complete Response, Warning Letters For Lumizyme

Despite receiving a “complete response” letter and manufacturing warning letter on the same day, Genzyme remains upbeat about the likelihood of approval for its 2,000L scale-up of Myozyme.

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