Gaucher
Sanofi Gaucher drug approved in Europe
January 22, 2015Sales 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 …
Priority review for Gaucher drug
December 12, 2013Sales 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 …
Pfizer Gaucher drug rejected by CHMP
June 25, 2012Sales 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, 2012Sales 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, 2011Manufacturing 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, 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 …
Shire’s Vpriv recommended for European approval
June 28, 2010Sales 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, 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 …
Predatory Icahn moves in on weakened Genzyme
February 23, 2010Research 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 files for Gaucher drug in Europe
December 1, 2009Sales 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, 2009Research 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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