Fabrazyme
Genzyme starts shipping Fabrazyme from Framingham facility
March 6, 2012Manufacturing and Production Fabrazyme, Framingham, Genzyme
Sanofi subsidiary Genzyme has shipped the first supplies of Fabry disease treatment Fabrazyme produced at its new plant in Framingham, …
Genzyme’s Framingham site cleared by FDA
January 24, 2012Manufacturing and Production FDA, Fabrazyme, Fabry, Genzyme
The FDA has cleared Genzyme to begin production of Fabrazyme at its new manufacturing site. The approval of the new …
Genzyme lifted by EU approval of Fabrazyme facility
January 20, 2012Manufacturing and Production Boston, EMA, Fabrazyme, Genzyme
Sanofi subsidiary Genzyme moved a crucial step closer to resolving its long-standing manufacturing problems after the European Medicines Agency gave …
Genzyme confirms further Fabrazyme delay
September 13, 2011Manufacturing and Production Fabrazyme, Genzyme, pharma manufacturing news
Genzyme has been forced to delay shipments of its Fabry disease treatment Fabrazyme once again, blaming its “quality release process”. …
GSK signs rare diseases deal with Amicus
November 1, 2010Research and Development, Sales and Marketing Amicus Therapeutics, Fabrazyme, Fabry disease, GSK, GlaxoSmithKline, pharmacological chaperones
GlaxoSmithKline is partnering with US biopharmaceutical company Amicus Therapeutics to develop and commercialise its late-stage Fabry disease drug Amigal. GSK …
EMA panel advises Fabrazyme switch
July 7, 2010Manufacturing and Production Fabrazyme, Genzyme, manufacturing compliance
Doctors in Europe have been told they should consider switching patients with Fabry disease away from treatment with Genzyme’s Fabrazyme …
More woe for Genzyme as shipping delays continue
July 6, 2010Manufacturing and Production Cerezyme, Fabrazyme, Gaucher, Genzyme, manufacturing compliance
Genzyme is expecting further delays in shipments of two key products as it struggles to bring its troubled Allston Landing …
Genzyme confirms details of consent decree and $175m fine
May 27, 2010Manufacturing and Production Cerezyme, Fabrazyme, Genzyme, Lumizyme, Thyrogen, manufacturing compliance
Genzyme’s predictions on the penalties levied for the ongoing problems at its manufacturing facility in Allston Landing have been confirmed, …
Shire revenue dips after generic Adderall hit
April 30, 2010Sales and Marketing Adderall, Fabrazyme, Gaucher's, Shire
Shire’s first quarter revenues fell by 5% after its ADHD treatment Adderall XR succumbed to generic competition from Teva. This …
Genzyme fined $175m for manufacturing problems
April 22, 2010Manufacturing and Production Cerezyme, Cerezyme Fabrazyme Gaucher's Genzyme, Fabrazyme, Gaucher's, Genzyme, manufacturing compliance
The FDA seems to have lost patience with biotechnology company Genzyme over contamination problems at its manufacturing facilities, levying a …
FDA flexes muscles over ailing Genzyme plant
March 29, 2010Manufacturing and Production Cerezyme, Fabrazyme, Gaucher, Genzyme, manufacturing compliance
Manufacturing compliance problems continue to weigh down US biotechnology company Genzyme, with the US Food and Drug Administration now saying …
Genzyme plays down Irish contamination
March 18, 2010Manufacturing and Production Cerezyme, Contamination, Fabrazyme, Genzyme
The contamination problems plaguing Genzyme in the US have also appeared in product manufactured at its plant in Waterford, Ireland, …
Hospira helps Genzyme tackle manufacturing problems
January 6, 2010Manufacturing and Production Cerezyme, Fabrazyme, Genzyme, Hospira
Genzyme has taken the decision to move the fill and finish stages of its manufacturing process to Hospira in order …
