Navigation Links
Shire Receives Fast Track Designation for velaglucerase alfa for Gaucher Disease
Date:7/15/2009

LEXINGTON, Massachusetts, July 16 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for velaglucerase alfa, its enzyme replacement therapy in development for the treatment of Type I Gaucher disease. Shire is working with the FDA to determine subsequent steps and timing for the filing of its NDA.

Fast Track designation is an FDA approved process that facilitates the development and expedites the review of drugs to treat serious diseases and fill an unmet medical need with the goal of getting important new treatments to patients earlier. This process allows a company to file the sections of the NDA as they become available instead of filing all the sections at once. It also enables the agency to commence its review and proceed on a rolling basis as the additional sections are completed and submitted for review.

Shire is completing a phase III clinical program that includes three phase III controlled studies involving over 100 patients at 24 sites in 10 countries around the world.

On July 6th, Shire announced that it filed a treatment protocol for velaglucerase alfa at the request of the FDA, which if accepted would allow physicians to treat Gaucher disease patients with velaglucerase alfa on an early access basis, ahead of commercial availability in the US. Under the conditions of the treatment protocol, Shire would provide velaglucerase alfa free of charge initially, in order to provide access to patients as quickly as possible.

Velaglucerase alfa is made with Shire's proprietary technology, in a human cell line. The enzyme produced has the exact human amino acid sequence and carries a human glycosylation pattern.


'/>"/>

SOURCE Shire Plc
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Shire has Filed a Treatment Protocol for Velaglucerase Alfa for Gaucher Disease
2. Shire Presented Results of a New Database Analysis on Lialda(R) (Mesalamine) and Other 5-ASAs for Ulcerative Colitis at Digestive Disease Week
3. Shire Announces Study Results of the Effects of INTUNIV(TM) (Guanfacine) Extended Release on Secondary Measures in Children with ADHD and Oppositional Symptoms
4. Shire Withdraws European Application for DAYTRANA(TM) (Methylphenidate Transdermal System)
5. Shire to add New Orphan Drug to its HGT Portfolio - EU Launch Imminent
6. Shire Announces Approval of ELAPRASE(R) (idursulfase) in Brazil
7. Shires Investigational Nonstimulant ADHD Treatment INTUNIV(TM) (Guanfacine Extended Release) Demonstrated Significant Efficacy in Reducing ADHD Symptoms at All Measured Time Points Up to 24 Hours Postdose
8. Shire to Present Additional Scientific Data on ADHD Treatment Portfolio at American Psychiatric Association Annual Meeting
9. Shire Enhances its Orphan Drug Pipeline With the Acquisition of a New Clinical Candidate for Metachromatic Leukodystrophy
10. Shire Strives to Increase Adherence Among Chronic Kidney Disease Stage 5 Patients
11. USC Keck School of Medicines Dr. Alan Epstein Receives Prestigious National Cancer Institute RAID Award for Breakthrough IL-2 Molecule Therapeutic
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/29/2014)... Aug. 29, 2014  Chuma Holdings, Inc. (OTCBB:CHUM) ... and turnkey support services for the lawfully organized ... processed and approved the Company,s name and symbol ... Corporation will be known as Chuma Holdings, Inc. ... through a merger with the Company,s wholly-owned subsidiary, ...
(Date:8/29/2014)... , Aug. 29, 2014 Pomerantz LLP ... S.A. ("EDAP" or the "Company") (NASDAQ: EDAP ) ... in United States District Court, Southern District of ... is on behalf of a class consisting of all ... 1, 2013 and July 30, 2014, inclusive (the "Class ...
(Date:8/29/2014)... Aug. 29, 2014 Thoratec Corporation (NASDAQ: ... circulatory support therapies to save, support and restore failing ... 2014 Morgan Stanley Global Healthcare Conference on Wednesday, September ... and Chief Executive Officer, will provide an update on ... (9:55 a.m., Pacific Daylight Time).   A ...
Breaking Medicine Technology:CannaMed Announces Name Change and Trading Symbol Change 2CannaMed Announces Name Change and Trading Symbol Change 3SHAREHOLDER ALERT: Pomerantz Law Firm Announces the Filing of a Class Action against EDAP TMS S.A. and Certain Officers - EDAP 2SHAREHOLDER ALERT: Pomerantz Law Firm Announces the Filing of a Class Action against EDAP TMS S.A. and Certain Officers - EDAP 3
... ORANGE, N.J., July 13, 2011 Kessler Foundation ... ( www.kessler-rehab.com ) are the first rehabilitation centers ... V6, an advanced robotic training system designed to ... brain injury, stroke, multiple sclerosis or other neurological ...
... NEW YORK, July 13, 2011 ACCESS PHARMACEUTICALS, ... biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments ... announced that it has signed an agreement to restructure ... year. The amended agreement provides for extension of 50% of ...
Cached Medicine Technology:Kessler is the First Rehabilitation Center in the Nation to Use New Robotic Gait Training System 2Kessler is the First Rehabilitation Center in the Nation to Use New Robotic Gait Training System 3Access Pharmaceuticals Announces Restructuring of Outstanding Senior Convertible Note 2Access Pharmaceuticals Announces Restructuring of Outstanding Senior Convertible Note 3
(Date:8/30/2014)... (PRWEB) August 30, 2014 Ticket Down ... Chile exhibition match next Saturday at Levi's Stadium. ... diehard soccer fans in the United States due to the fact ... just about every major city. Many of these games were ... Brazil this past summer. , Levi’s Stadium is a brand new ...
(Date:8/30/2014)... Patients suffering from vitiligo can now discover ... review published by Daily Gossip. , Vitiligo is ... is no wonder that numerous sufferers search for an ... is one of the most appreciated such methods at ... stop the spread of this disorder immediately, while completely ...
(Date:8/30/2014)... (PRWEB) August 30, 2014 The Plastic ... in New Jersey and even in the U.S. to ... takes inches off of patients’ waists with deep-tissue heating. ... in small sections, Vanquish is more inclusive to target ... Patients lay comfortably under panels about one inch away ...
(Date:8/30/2014)... Hicksville, NY (PRWEB) August 30, 2014 ... Organizations throughout the planet has been one of ... in order to create a positive impact around ... aesthetics and staffed with top trained executives and ... millions of people worldwide. Vital statistics demonstrate ...
(Date:8/30/2014)... VA (PRWEB) August 30, 2014 Seniors Guide, ... articles recently that focus on Alzheimer’s Disease, Dementia, and ... revealed to the public of being diagnosed with the Alzheimer’s, ... latest movie, “I’ll Be Me”. The movie, out on ... while focusing on his diagnosis of the disease – which ...
Breaking Medicine News(10 mins):Health News:Mexico vs. Chile Tickets at Levi's Stadium in Santa Clara, CA: TicketDown.com Offers Promo Code for Mexico vs. Chile Exhibition Game on September 6th 2Health News:Natural Vitiligo Treatment Review Exposes Fast Method for Skin Repigmentation 2Health News:NJ Top Docs Presents, The Plastic Surgery Group 2Health News:Cradle of Aviation Museum Opens Its Doors to Long Island Scientologists 2Health News:Alzheimer’s Disease and Dementia Focus on Retirement Website SeniorsGuideOnline.com 2
... assured that the Federal Government would provide $47,000 as ... ,This money would help the community health care ... this difficult transitional period. Health services play a major ... problems backing that up with financial support. Due to ...
... extremely optimistic trends in the reaction to same-sex ... to such marriages across the country. Gay rights ... opposition to same-sex marriages, while also expressing that ... highest court order prohibiting inter-state homosexual marriages. ...
... the firing of editor-in –chief, John Hoey, the Canadian ... controversies//. The February firing of Dr. Hoey and senior ... international controversy regarding the editorial independence of medical journals. ... ran several articles and editorials that sparked anger among ...
... and lifestyle alone will suffice to prevent about two-thirds of ... disposition play a role in skin cancer. While anyone can ... light-colored skin that freckle easily, researchers said. ... members who also have had the disease, but everyone should ...
... According to the joint study conducted by India and Canada which ... research institute reported// a decrease in the HIV prevalence. The ... HIV in the states of Tamil Nadu, Maharashtra, Karnataka and Andhra ... period. This tread is mainly seen in the four south Indian ...
... planning to record the barks and growls of hundreds of dogs ... Taylor, 23, of Brighton in southern England, is looking for about ... part in the study, it was reported Thursday. ,"We ... and growl including banging on doors and windows, playing with them ...
Cached Medicine News:Health News:Future of Canadian Medical Association Journal Threatened 2
Lightly Curved-Blunt Tips Rounded Blades; 1mm Eye in Blades; 27mm from mid screw to tip. Matte finish; Stainless Steel, overall length 120mm...
... SURPASS Perfusion Catheter is indicated ... stenotic portion of a coronary ... for the purpose of improving ... Catheters are also designed to ...
16mm from Mid-screw to Tips, blunt tips; overall length 110mm; Stainless Steel...
Angled 45 Degrees to Right, 9.5mm blade, gently curved .5x .25mm blunt tips; Lower blade is 0.5mm longer; 14mm from mid screw to tip; (Available in left and right; ) overall length 120mm; Stainless ...
Medicine Products: