Gaucher

Showing 11 posts of 11 posts found.

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Sanofi Gaucher drug approved in Europe

January 22, 2015
Sales and Marketing Cerdelga, Cerezyme, Gaucher, Sanofi, eliglustat, imiglucerase

The European Commission has approved Sanofi-owned Genzyme’s Cerdelga for the treatment of Gaucher disease Type 1.Designed for a condition that …

Sanofi image

Priority review for Gaucher drug

December 12, 2013
Sales and Marketing EMA, FDA, Gaucher, Genzyme, Sanofi

The FDA is to conduct a speedy investigation into Sanofi’s twice-daily oral candidate for Gaucher disease, which means that Cerdelga …

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Pfizer Gaucher drug rejected by CHMP

June 25, 2012
Sales and Marketing Elelyso, FDA, Gaucher, Pfizer, Shire, Vpriv

A European committee has refused marketing authorisation for Pfizer’s Gaucher disease drug Elelyso, as a competitor drug has exclusivity to …

Pfizer enters Gaucher disease market

May 3, 2012
Sales and Marketing Cerezyme, Elelyso, Gaucher, Genzyme, Pfizer, Shire, Vpriv

Pfizer has gained FDA approval for its new Gaucher disease drug Elelyso.  Elelyso (taliglucerase alfa) is an enzyme replacement therapy …

Shire facility could answer rare disease drug shortage

November 27, 2011
Manufacturing and Production Fabry disease, Gaucher, Shire, Vpriv

Shire has filed applications with the European and US regulators to produce its Gaucher disease drug Vpriv (velaglucerase alfa) at …

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 …

Shire’s Vpriv recommended for European approval

June 28, 2010
Sales and Marketing Brinavess, Gaucher, Rapiscan, Ruconest, Shire, Sycrest

Shire has won backing from a key European regulatory committee for its new Gaucher disease orphan drug. Vpriv was one …

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 …

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Predatory Icahn moves in on weakened Genzyme

February 23, 2010
Research and Development, Sales and Marketing Gaucher, Genzyme, Icahn

Corporate raider Carl Icahn has made a bid to gain control of beleaguered Genzyme as it struggles to overcome major …

Shire

Shire files for Gaucher drug in Europe

December 1, 2009
Sales and Marketing Cerezyme, Gaucher, Shire

 Shire has followed up its marketing applications for Gaucher disease treatment velaglucerase alfa in the US and Canada with a …

Genzyme says Cerezyme shortages could last longer than expected

August 17, 2009
Research and Development, Sales and Marketing Gaucher, Genzyme

The shortage of Genzyme's enzyme replacement therapy Cerezyme look set to last longer than expected, as the company has taken …

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