Navigation Links
Shire Presents Positive Efficacy and Safety Data for velaglucerase alfa in Treatment of Naive Patients With Type 1 Gaucher Disease
Date:2/11/2010

nal pain, pharyngolaryngeal pain and headache. Most adverse events were of mild to moderate severity. No patients withdrew from the trial due to an adverse event. No patients in the 5 year extension study developed antibodies.

About velaglucerase alfa

Velaglucerase alfa is an investigational enzyme replacement therapy for Type 1 Gaucher disease. Velaglucerase alfa is made using Shire's gene-activation technology, in a human cell line. The enzyme produced has the exact human amino acid sequence and has a human glycosylation pattern.

The United States Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) for velaglucerase alfa and has issued an action date for the NDA for velaglucerase alfa of February 28, 2010 under the Prescription Drug User Fee Act (PDUFA).  

About Gaucher disease
Gaucher disease is an autosomal recessive disorder caused by mutations in the GBA gene which results in a deficiency of the lysosomal enzyme beta-glucocerebrosidase. This enzymatic deficiency causes an accumulation of glucocerebroside, primarily in macrophages. In this lysosomal storage disorder (LSD), clinical features are reflective of the distribution of Gaucher cells in the liver, spleen, bone marrow, skeleton, and lungs. The accumulation of glucocerebrosidase in the liver and spleen leads to organomegaly. Bone involvement results in skeletal abnormalities and deformities as well as bone pain crises. Deposits in the bone marrow and splenic sequestration lead to clinically significant anemia and thrombocytopenia.

Gaucher disease is the most prevalent LSD. Gaucher disease has classically been categorized into 3 clinical types. Type 1 is the most common; it is distinguished from Type 2 and Type 3 by the lack of neurological symptoms. Type 1 Gaucher disease is characterized by variability in signs
'/>"/>

SOURCE Shire plc
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related medicine technology :

1. Shire Submits Biologics License Application (BLA) for REPLAGAL(R) With the U.S. Food and Drug Administration (FDA)
2. Shire Expands its Award-Winning ADHD Support Resource, ADHDSupport.com, by Launching an ADHD Twitter(TM) Page
3. Shire and Teva Settle Litigation Concerning Supply of ADDERALL XR Authorized Generic
4. Shire Announces Publication of Open-Label Study on Coadministration of INTUNIV(TM) (guanfacine) Extended-Release Tablets with Stimulants
5. Shire Re-Launches FOCUS, an Online, Personalized Patient Support Program for Adults with ADHD Taking Vyvanse(R) (lisdexamfetamine dimesylate) Capsules CII
6. Shire Reports Tolerability and Clinical Effects Results of Daytrana(R) (methylphenidate transdermal system) from Study in Adolescents with ADHD
7. Shire Continues to Deliver Excellent Growth From Core Products
8. Shire to Present Important Study Findings on its ADHD Treatments at a Major Psychiatric Meeting on October 29 and 30
9. Shire Presents Results of Five Lialda(R) (mesalamine) Analyses at ACG 2009 Annual Scientific Meeting
10. Shire Targets Fourth Quarter Filing of BLA for REPLAGAL(R) for Fabry Disease With U.S. FDA
11. Shire and Sandoz Settle all Pending Litigation Concerning ADDERALL XR(R)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/24/2014)... 2014 PuraMed BioScience®, Inc., (OTC Pink: PMBS), ... and healthcare products, announced it received the initial funding ... advanced headache relief product, for planned distribution to 1,000 ... , Washington State , and ... MigraPure H Advanced headache relief gel formulation completed, PuraMed ...
(Date:12/24/2014)... 23, 2014   Synageva BioPharma Corp. ... developing therapeutic products for rare disorders, today announced ... the Marketing Authorization Application (MAA) for sebelipase alfa ... company,s request for accelerated assessment, which has the ... The MAA, and the Biologics ...
(Date:12/24/2014)... 23, 2014 In response to urgent requests from the ... Sierra Leone , Direct Relief delivered two 10-bed ... the treatment of local health workers who contract Ebola while ... Ebola care center was constructed for foreign health care workers ... available for local Sierra Leonean health workers. With ...
Breaking Medicine Technology:PuraMed BioScience Nears Final Stages Needed for Distribution of MigraPure H 2PuraMed BioScience Nears Final Stages Needed for Distribution of MigraPure H 3Synageva BioPharma Announces Sebelipase Alfa Marketing Authorization Application Validated By The EMA 2Synageva BioPharma Announces Sebelipase Alfa Marketing Authorization Application Validated By The EMA 3First Ebola Treatment Unit for Local Health Workers Arrives in Sierra Leone 2
... proposal now under consideration by the Medicare Payment Advisory ... services as part of a broader effort to fix ... of many clinical labs. That was the message of ... sent today to MedPAC Chairman Glenn Hackbarth. The letter ...
... 16, 2011 Many failing NHS hospitals across the ... billion rescue mission, according to a leading figure. Tony ... 40 trusts do not have enough money and therefore will need ... the Reform think tank, the professor argues that the NHS hospitals ...
Cached Medicine Technology:ACLA Voices Strong Concern Over MedPAC Proposal to Cut Medicare Reimbursement for Laboratory Services 2Failing NHS Hospitals in Need of a Business Rescue Plan 2
(Date:12/26/2014)... (PRWEB) December 26, 2014 India Network ... insurance in the USA, announced today a new version ... members in choosing the right plan for their visiting ... complexity out of the selection process when choosing an ... age group with only a few clicks. Many elderly ...
(Date:12/25/2014)... 26, 2014 This is a professional ... global Sterilizers industry with a focus on the Chinese ... status of the Sterilizers manufacturers and is a valuable ... interested in the industry. This report provides a basic ... manufacturing technology. In this part, the report presents the ...
(Date:12/25/2014)... December 26, 2014 “Every three months the ... changes. A-line sweetheart evening dress will be one of the ... manager of Yunx.co.uk says. Today, the company releases 26 A-line ... up to 80% off. , “We are trying our ... style with our latest designs. Along with affordable prices, we ...
(Date:12/25/2014)... (PRWEB) December 25, 2014 BambooFlooringChina.com sells ... high quality bamboo flooring. Today, the company announces ... in many styles and colors. , BambooFlooringChina.com is the ... CEO, the promotion is valid until Jan. 20, 2015. ... strips and woven with a natural thread. All the ...
(Date:12/25/2014)... -- The risk of burns from fires and cooking ... be extra cautious, an expert says. "Between Thanksgiving ... in patients coming in with burns," said Dr. Steven ... Burn Center of Stony Brook University Hospital in New ... but if not careful, could quickly turn tragic," Sandoval ...
Breaking Medicine News(10 mins):Health News:India Network Health Insurance Announces new Comprehensive Pre-existing Condition Coverage policy for Visitors to the United States 2Health News:India Network Health Insurance Announces new Comprehensive Pre-existing Condition Coverage policy for Visitors to the United States 3Health News:Sterilizers Industry Global and Chinese Analysis for 2009-2019 Now Available at ReportsnReports.com 2Health News:Sterilizers Industry Global and Chinese Analysis for 2009-2019 Now Available at ReportsnReports.com 3Health News:Various Styles of Bamboo Mats in Many Colors from BambooFlooringChina.com 2Health News:Don't Let Burns Mar Your Holidays 2
... , ... Panama City, Fla. (PRWEB)July ... today announced AdvancedSMAT™, an innovative tool that helps healthcare organizations ... functionality. AdvancedSMAT saves time and improves searching efficiencies by offering ...
... July 14 /Xinhua-PRNewswire/ -- WuXi PharmaTech (NYSE:,WX), ... research,and development outsourcing company with operations in ... Dr. Richard M. Soll has joined WuXi ... (Logo: http://www.newscom.com/cgi-bin/prnh/20040705/CNM002LOGO ), As ...
... Latinos with tools to lead a healthy ... ... with the National Council of La Raza (NCLR) to unveil a small,tool aimed ... 148-page pocket-sized health book, Buena Salud, Buena Vida --,Su Guia de Recursos de ...
... which can cause skin cancer , , SUNDAY, July 13 (HealthDay ... people use as the summer sun rises high and threatens ... are not only painful, they can lead to skin cancer, ... , But, new research has led some to question the ...
... and staff of the,American Heart Association extend their sympathy ... died yesterday at the age of 99., "Michael ... responsible for developing the field of cardiovascular surgery,",said Timothy ... started surgery of the aorta, the main artery in ...
... LOUISVILLE, Ky., July 12 Dave Robert,Armstrong, a 32-year-old ... around the world by receiving a hand transplant today, ... Hand Care Center by,Kleinert Kutz and University of Louisville ... at approximately 2:08 a.m. (EDT),today involved a six-member hand ...
Cached Medicine News:Health News:Noesis Health Introduces AdvancedSMAT for Better Management of Cloverleaf Message Files 2Health News:Dr. Richard M. Soll Joined WuXi PharmaTech (NYSE: WX) as VP of Medicinal Chemistry 2Health News:Lilly Partners With the National Council of La Raza to Fight Chronic Disease 2Health News:Lilly Partners With the National Council of La Raza to Fight Chronic Disease 3Health News:Lilly Partners With the National Council of La Raza to Fight Chronic Disease 4Health News:Are You Getting Burned by Your Sunscreen? 2Health News:Are You Getting Burned by Your Sunscreen? 3Health News:American Heart Association Saddened by Death of Surgical Pioneer Michael E. DeBakey 2Health News:Nation's Fourth Hand Transplant Performed at Jewish Hospital Hand Care Center by Kleinert Kutz and University of Louisville Surgeons 2Health News:Nation's Fourth Hand Transplant Performed at Jewish Hospital Hand Care Center by Kleinert Kutz and University of Louisville Surgeons 3
Angled shafts with 9 mm scaled jaws. 1 mm teeth on one jaw fit into holes on the other jaw. Slide lock and serrated handle with polished finish. Left....
Shafts angled 45 degrees, 10 mm from tip to bend. Tips curved with 0.5 mm, 1 x 2 teeth. Serrated handle with polished finish....
Smooth pointed tips open to 3.0 mm. 45 degree cross action angled shafts. Tip to Angle Length: 12.0 mm. Round handle....
Curved shafts with fine pointed tips. Smooth handle with dull finish....
Medicine Products: