Navigation Links
Shire Receives CHMP Positive Opinion for VPRIV(TM) (velaglucerase alfa) for the Treatment of Type 1 Gaucher Disease in the European Union
Date:6/25/2010

CAMBRIDGE, Massachusetts, June 25, 2010 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion on the marketing authorisation for VPRIV(TM) (velaglucerase alfa), the company's enzyme replacement therapy (ERT) for the treatment of type 1 Gaucher disease. The CHMP positive opinion will now be forwarded to the European Commission for ratification, and marks a significant milestone in bringing a new Gaucher treatment to market in all EU Member States.

"Gaucher disease is a rare and often debilitating condition," said Professor Timothy Cox, Department of Medicine, University of Cambridge based at Addenbrookes Hospital UK. "I am pleased that, given the difficulties in supplying enzyme treatment for our patients over the last year, we will soon have the opportunity to prescribe velaglucerase alfa without regulatory constraints; the treatment represents an important option in this therapeutic arena."

In many European countries patients have been receiving VPRIV on an early access named patient basis, developed in partnership with national and regional authorities. These programs, designed specifically to address the continuing supply shortage of the only other commercially marketed ERT, have experienced strong uptake from physicians and patients and have garnered the support of treatment working groups and advocacy organisations. To date, hundreds of patients in the EU have been treated with VPRIV through Shire's clinical trials or early access mechanisms.


'/>"/>
SOURCE Shire plc
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related biology technology :

1. Shire plc Appoints Two New Board Directors
2. INTUNIV(TM) - Shire Files Suit Against Anchen Pharmaceuticals, Inc. and Anchen, Inc.
3. Shire Receives 2010 Corporate Award From the National Organization for Rare Disorders (NORD) for the Development of VPRIV (velaglucerase alfa for Injection)
4. INTUNIV(TM) - Shire Files Suit Against Actavis Elizabeth LLC and Actavis Inc.
5. Shires Replenished Portfolio Drives Excellent Quarterly Performance
6. Shire Receives INTUNIV (TM) Paragraph IV Notice Letter From Teva Pharmaceuticals
7. Shire Supports Rare Disease Day 2010
8. Shire Announces FDA Approval of VPRIV(TM) (velaglucerase alfa for injection) for the Treatment of Type 1 Gaucher Disease
9. Shire Provides Update on Biologics License Application (BLA) Filing for REPLAGAL(R) (agalsidase alfa) With the U.S. Food and Drug Administration (FDA)
10. Shire Submits European Marketing Authorization Application (MAA) for velaglucerase alfa for the Treatment of Type 1 Gaucher Disease
11. New Shire Board Member
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/24/2014)... and NEW YORK , ... from its open-label pilot study of mazindol in children ... Development and Therapy in December 2014 . ... mazindol in children with attention deficit/hyperactivity disorder" ( Konofal ... 2014 Dec 1;8:2321-2332. eCollection 2014 ) shows ...
(Date:12/22/2014)... 22, 2014 GenomeDx Biosciences today announced that ... Classifier, a genomic test for prostate cancer, was able ... managed by radical prostatectomy without adjuvant therapy. Although rapid ... uncommon, using tumor genomics to identify these men who ... an important advance. The study has been published ...
(Date:12/19/2014)... Hershey, PA (PRWEB) December 19, 2014 ... a leading developer and manufacturer of needle-free injection ... an agreement with Immunomic Therapeutics, Inc. (“ITI”) for ... injection device with its LAMP™ vaccine platform. ... for an exclusive Worldwide license to the Biojector®-2000 ...
(Date:12/19/2014)... , Dec. 19, 2014 Bina Technologies, Inc. ... announced today that they have been acquired by Roche ... is a privately held company that provides a big ... generation sequencing (NGS) data for the academic and translational ... Sequencing Unit, and will continue to focus on development ...
Breaking Biology Technology:Redefining ADHD: A New Approach & A Shift of Paradigm in ADHD Therapeutics 2Redefining ADHD: A New Approach & A Shift of Paradigm in ADHD Therapeutics 3Study Published in European Urology Shows that the Decipher Prostate Cancer Classifier is Predictive of Rapid Metastasis in High-Risk Men who have had Prostate Surgery 2Study Published in European Urology Shows that the Decipher Prostate Cancer Classifier is Predictive of Rapid Metastasis in High-Risk Men who have had Prostate Surgery 3Bioject and Immunomic Therapeutics Enter into an Agreement for License of Needle-Free Technology for LAMP-vax Vaccines 2Bioject and Immunomic Therapeutics Enter into an Agreement for License of Needle-Free Technology for LAMP-vax Vaccines 3Bina Technologies is acquired by Roche. 2Bina Technologies is acquired by Roche. 3
... May 25, 2012  Oncobiologics, Inc. announced today that ... established biopharmaceutical industry experts. Stephen J. McAndrew, Ph.D. ... J. Benn, Ph.D. has joined the company as ... also announced its new Scientific Advisory Board, which ...
... and microbiologists have sent out biopsies, slides, X-rays and ... take days to get back and cannot be used ... entrepreneur-inventor and Chairman of New York College of Health ... Acupuncture and Massage Therapy in the nation, is changing ...
... YORK, May 24, 2012 Reportlinker.com announces ... available in its catalogue: ... http://www.reportlinker.com/p0157456/Optical-Coatings-Technologies-and-Global-Markets.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Paint_and_Coating ... OBJECTIVES This BCC study analyzes the ...
Cached Biology Technology:Oncobiologics Fills Key Leadership Positions and Names Scientific Advisory Board 2Oncobiologics Fills Key Leadership Positions and Names Scientific Advisory Board 3College Chairman And Prolific Inventor Develops Life-Saving, Real-Time Diagnostic Technologies 2College Chairman And Prolific Inventor Develops Life-Saving, Real-Time Diagnostic Technologies 3Optical Coatings: Technologies and Global Markets 2Optical Coatings: Technologies and Global Markets 3Optical Coatings: Technologies and Global Markets 4Optical Coatings: Technologies and Global Markets 5Optical Coatings: Technologies and Global Markets 6Optical Coatings: Technologies and Global Markets 7Optical Coatings: Technologies and Global Markets 8Optical Coatings: Technologies and Global Markets 9Optical Coatings: Technologies and Global Markets 10Optical Coatings: Technologies and Global Markets 11Optical Coatings: Technologies and Global Markets 12
(Date:12/10/2014)... Dec. 9, 2014  Wake Forest Baptist Medical Center today ... its School of Medicine. Funding for this $50 million ... that will be publicly launched next summer. ... the former 60 series R.J. Reynolds Tobacco Company complex, ... will begin immediately with plans to be ready to ...
(Date:12/5/2014)... Calif. , Dec. 4, 2014 ... has boosted investments in new testing and inspection ... also given rise to a range of innovative ... the requirements of Generation Y, which is generally ... As a result, product development strategies of test ...
(Date:12/3/2014)... -- As part of our commitment to offering the ... announce the release of a new reader that will ... data that they need. The Atlas 2000 ... readers. Many such devices have serious shortcomings when it ... models force users to navigate numerous complicated steps in ...
Breaking Biology News(10 mins):Wake Forest Baptist to Build New Medical Education Facility In Wake Forest Innovation Quarter 2Wake Forest Baptist to Build New Medical Education Facility In Wake Forest Innovation Quarter 3Wake Forest Baptist to Build New Medical Education Facility In Wake Forest Innovation Quarter 4Emerging Technologies Enable Smarter Monitoring of Assets, Push Industrial Testing, Inspection and Monitoring Market 2Emerging Technologies Enable Smarter Monitoring of Assets, Push Industrial Testing, Inspection and Monitoring Market 3Emerging Technologies Enable Smarter Monitoring of Assets, Push Industrial Testing, Inspection and Monitoring Market 4Inception Technologies to Release New Biometric Reader 2
... to a chemical once used widely in plastic bottles and still ... for higher risk of heart and kidney disease in children and ... School of Medicine researchers published in the January 9, 2013, online ... Laboratory studies suggest that even low levels of bisphenol ...
... of Korea, January 9, 2013The Korea Advanced Institute of ... energy and petrochemicals enterprise, signed a memorandum of understanding ... and pledged to jointly collaborate in research and development ... energy challenges. Under the MOU, the two ...
... Biophysical Society has announced the winners of its Education ... Annual Meeting at the Pennsylvania Convention Center in Philadelphia, ... all of whom are students and postdoctoral fellows, are ... be presenting their research during the meeting, will receives ...
Cached Biology News:BPA linked to potential adverse effects on heart and kidneys 2BPA linked to potential adverse effects on heart and kidneys 3Biophysical Society announces winners of 2013 Education Committee travel awards 2Biophysical Society announces winners of 2013 Education Committee travel awards 3Biophysical Society announces winners of 2013 Education Committee travel awards 4Biophysical Society announces winners of 2013 Education Committee travel awards 5Biophysical Society announces winners of 2013 Education Committee travel awards 6
Alkaline Phosphatase (E. coli C75), 100 units. Removes 5'-phosphates from DNA. Category: Nucleotides & Enzymes & Biochemicals, Modifying Enzymes, Alkaline Phosphatases....
... Kit with CyScribe GFX Purification Kit, ... purification of Cy3- and Cy5-labeled cDNA.Optimized ... cDNA labeling and purification.Flexible and optimized ... labeling reactions with either Cy3- or ...
... CyScribe Post-Labeling Kit with CyScribe GFX ... generation and purification of Cy3- and ... for complete cDNA labeling and purification.Flexible ... for performing labeling reactions with either ...
Collected from sexually mature, mixed sex, mixed breed dogs. Serum from specific breeds available by request....
Biology Products: