Gaucher disease: FDA approves VPRIV
The U.S. Food and Drug Administration has approved velaglucerase alfa for injection (VPRIV) to treat children and adults with a form of the rare genetic disorder Gaucher disease.
View ArticleShire receives marketing approval from FDA for VPRIV
Shire plc, the global specialty biopharmaceutical company, announced today that the U.S. Food and Drug Administration has granted marketing approval for VPRIV, a human cell line derived enzyme...
View ArticlePositive data from Shire's Phase III trial of TKT-034 in Type 1 Gaucher...
Shire plc, the global specialty biopharmaceutical company, today presented positive data from a Phase III clinical trial (TKT-034) designed to evaluate the safety of switching to VPRIV (velaglucerase...
View ArticleShire announces study results of Vyvanse Capsules CII for treatment of ADHD...
Shire plc, the global specialty biopharmaceutical company, today announced the results of a study evaluating the safety and efficacy of Vyvanse (lisdexamfetamine dimesylate) Capsules CII for the...
View ArticleVPRIV receives positive opinion from CHMP for treatment of type 1 Gaucher...
Shire plc, the global specialty biopharmaceutical company, announced today that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion on the...
View ArticleShire presents positive data from TKT-025 EXT Phase I/II study for VPRIV in...
Shire plc, the global specialty biopharmaceutical company, today announced positive data from its long-term extension to its open label Phase I/II study (TKT-025 EXT) for VPRIV® (velaglucerase alfa),...
View ArticleShire receives European marketing approval for VPRIV therapy to treat type 1...
Shire, the global specialty biopharmaceutical company, announced today that the European Commission has granted marketing authorisation for VPRIV(R) (velaglucerase alfa), a human cell line derived...
View ArticleHealth Canada approves VPRIV enzyme replacement therapy for type 1 Gaucher...
Shire plc, the global specialty biopharmaceutical company, announces that Health Canada has approved VPRIV (velaglucerase alfa), an enzyme replacement therapy (ERT) for long-term use in pediatric and...
View ArticleShire's Replagal and VPRIV data on Gaucher and Fabry patients presented at...
Shire plc, the global specialty biopharmaceutical company, presented new data for Replagal in patients with Fabry disease, and VPRIV in patients with type 1 Gaucher disease, at the 2011 American...
View ArticleEMA approves Shire's new REPLAGAL manufacturing facility in Lexington
Shire plc, the global specialty biopharmaceutical company, today announced that the European Medicines Agency has approved the purification of REPLAGAL® (agalsidase alfa) drug substance at its new...
View Article
