What is the reason being for Genzyme Corp’s Pompe drug not approved- manufacturing deficiencies?
* FDA rejects Genzyme’s Pompe disease drug * Cites deficiencies at manufacturing plant in Boston * Shares up as shipping still on track (Updates with details from company conference call) By Toni Clarke BOSTON, Nov 16 (Reuters) – Genzyme Corp (GENZ.O), which is struggling through the most trying period in its history, said on Monday U.S. regulators will not approve its drug to treat Pompe disease, a rare muscle disorder, until it addresses manufacturing deficiencies at its Allston Landing plant in Boston. The ruling by the U.S. Food and Drug Administration follows the agency’s announcement last week that it had found foreign particles, such as stainless steel fragments and non-latex rubber, in vials of several Genzyme products, including its top-selling Gaucher disease treatment Cerezyme. Genzyme executives said on a conference call on Monday that the company has temporarily shut down the section of its Allston plant that handles vial filling and finishing while it fixes the problem. T
UPDATE 2-Genzyme’s Pompe drug rejected–new production woes Mon Nov 16, 2009 3:24pm EST * FDA rejects Genzyme’s Pompe disease drug * Cites deficiencies at manufacturing plant in Boston * Shares up as shipping still on track (Updates with details from company conference call) By Toni Clarke BOSTON, Nov 16 (Reuters) – Genzyme Corp (GENZ.O: Quote, Profile, Research, Stock Buzz), which is struggling through the most trying period in its history, said on Monday U.S. regulators will not approve its drug to treat Pompe disease, a rare muscle disorder, until it addresses manufacturing deficiencies at its Allston Landing plant in Boston. The ruling by the U.S. Food and Drug Administration follows the agency’s announcement last week that it had found foreign particles, such as stainless steel fragments and non-latex rubber, in vials of several Genzyme products, including its top-selling Gaucher disease treatment Cerezyme. Genzyme executives said on a conference call on Monday that the company ha
Genzyme Corp has been struggling through the roughest patch ever and informed on Monday that regulators have refused to approve its drug for the treatment of Pompe disease until the manufacturing deficiencies are addressed at its Allston Landing plant in Boston. Sources: http://topnews.
