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Examples
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Genzyme has been beset by manufacturing and regulatory problems since 2009, when a contamination-related shutdown of its Allston, Mass., plant caused a shortage of Genzyme's top-selling products, Fabrazyme for Fabry disease, and Cerezyme for a condition called Gaucher's disease.
Genzyme Gets Nod From FDA For Plant Sten Stovall 2012
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Genzyme's production problems have been a boost for U.K. drug company Shire PLC, whose Gaucher's treatment Vpriv and Fabry drug Replagal have been approved as alternative drugs.
Genzyme Gets Nod From FDA For Plant Sten Stovall 2012
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The plant is the sole source of Genzyme's top-selling products, Gaucher's disease treatment Cerezyme and the Fabry disease drug Fabrazyme, which are recovering from shortages that stemmed from the shutdown.
Sanofi Wins Long-Sought Biotech Deal Jeanne Whalen 2011
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The company reiterated its previous projection for having full global supply of Gaucher's disease treatment Cerezyme by year-end.
Genzyme Profit Soars as Operating Costs Decline Thomas Gryta 2010
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Importantly, the company expects supply of Gaucher's disease treatment Cerezyme and Fabry disease drug Fabrazyme to rise later this year.
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It has drugs for two rare genetic enzyme deficiency diseases – Gaucher's and Fabry's.
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The Allston facility, which has failed multiple regulatory inspections dating back to 2008, is the sole source of Gaucher's disease treatment Cerezyme and Fabry's disease drug Fabrazyme.
Genzyme Reports Loss, Drug Shortage as Plant Woes Linger 2010
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The facility, which has failed multiple regulatory inspections dating back to 2008, is the sole source of Genzyme's two top-selling drugs, Gaucher's disease treatment Cerezyme and Fabry disease drug Fabrazyme.
Genzyme Says FDA Plans Enforcement Action Thomas Gryta 2010
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These are Campath for treating multiple sclerosis; mipomersen, in development with Isis Pharmaceuticals Inc. for a rare cholesterol-related disorder; and eliglustat, an oral treatment for Gaucher's disease.
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The facility, which has failed multiple regulatory inspections dating back to 2008, is the sole source of Gaucher's disease treatment Cerezyme and Fabry disease drug Fabrazyme.
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