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Fabrazyme

Showing 13 posts of 13 posts found.

Genzyme Framingham image

Genzyme starts shipping Fabrazyme from Framingham facility

March 6, 2012
Manufacturing 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, …

News
Genzyme picture

Genzyme’s Framingham site cleared by FDA

January 24, 2012
Manufacturing 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 …

News

Genzyme lifted by EU approval of Fabrazyme facility

January 20, 2012
Manufacturing 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 …

News
Genzyme

Genzyme confirms further Fabrazyme delay

September 13, 2011
Manufacturing 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”. …

News

GSK signs rare diseases deal with Amicus

November 1, 2010
Research 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 …

News
GenzymeGate

EMA panel advises Fabrazyme switch

July 7, 2010
Manufacturing 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 …

News

More woe for Genzyme as shipping delays continue

July 6, 2010
Manufacturing 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 …

News

Genzyme confirms details of consent decree and $175m fine

May 27, 2010
Manufacturing 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, …

News

Shire revenue dips after generic Adderall hit

April 30, 2010
Sales 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 …

News
Genzyme

Genzyme fined $175m for manufacturing problems

April 22, 2010
Manufacturing 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 …

News

FDA flexes muscles over ailing Genzyme plant

March 29, 2010
Manufacturing 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 …

News
Genzyme

Genzyme plays down Irish contamination

March 18, 2010
Manufacturing 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, …

News

Hospira helps Genzyme tackle manufacturing problems

January 6, 2010
Manufacturing 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 …

News
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