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Multiple Factors Suggest Genzyme Still Faces Problems Related To Cerezyme

This article was originally published in The Pink Sheet Daily

Executive Summary

The biotech's decontaminated plant has reopened, but FDA plans to re-inspect the facility. In addition, Genzyme had to discard more in-process Cerezyme than expected and a competitor's investigational drug has received clearance for emergency use by FDA.

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Continued Genzyme Problems Offer Gaucher Opportunity To Competitors

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Continued Genzyme Problems Offer Gaucher Opportunity To Competitors

Genzyme's Allston Landing, Mass., plant - currently the only facility that produces its Cerezyme and Fabrazyme drugs - resumed working at full capacity on Aug. 28. But it seems the big biotech's manu-facturing woes are far from over: a mid-August visit by the European Medicines Agency found deficiencies, and a critical FDA inspection is still to come

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