Navigation Links
Shire Provides Update on Biologics License Application (BLA) Filing for REPLAGAL(R) (agalsidase alfa) With the U.S. Food and Drug Administration (FDA)
Date:2/24/2010

is currently approved for the treatment of Fabry disease in 45 countries and has been available to U.S. patients since December 2009 under an FDA-approved treatment protocol filed at the request of FDA. The REPLAGAL early access program was put in place as a result of the supply disruption of the only currently marketed treatment for Fabry disease in the U.S.

Financial guidance for 2010 provided in Shire's year-end results press release and earnings call on February 19, 2010 remains unchanged.

About REPLAGAL(R) (agalsidase alfa)

REPLAGAL is a human form of enzyme alpha-galactosidase A (a-Gal A) manufactured in a human cell line by gene activation. REPLAGAL is approved in 45 countries worldwide. REPLAGAL is not currently approved for commercial sale in the U.S.

REPLAGAL is the only human-cell-line-derived form of enzyme replacement therapy (ERT) that is indicated for the long-term treatment of patients with a confirmed diagnosis of Fabry disease ([alpha]-galactosidase A deficiency).


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

Page: 1 2 3 4 5 6 7

Related biology technology :

1. Shire Submits European Marketing Authorization Application (MAA) for velaglucerase alfa for the Treatment of Type 1 Gaucher Disease
2. New Shire Board Member
3. Shire Secures European Wide Label Extension for FOSRENOL(R) in Chronic Kidney Disease
4. New CapSure™ Cleanroom Wiper from Berkshire Corporation Captures and Retains 42 Times More Contaminant Particles
5. Shire Builds Competitive Position of its HGT Business through Research Collaboration with Santaris Pharma A/S on LNA Drug Platform
6. Santaris Pharma A/S Forms Strategic Alliance With Shire plc to Develop RNA-Based Medicines for the Treatment of Rare Genetic Disorders
7. Shire Initiates Two Adult ADHD Outreach Programs
8. Shire plc: Core Portfolio of Products Delivers 20% Sales Growth
9. Doctors in New Hampshire Now Treating Cancer with Non-Invasive Image-Guided Radiosurgery Using Novalis Tx(TM) Technology
10. The Crohns & Colitis Foundation of America and Shire Launch Virtual IBD March on the Hill to Increase Funding for Digestive Disease Research
11. Shire begins the year with a strong performance
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/10/2014)... 2014 On July 9 Prime ... presented Russia,s first national "Industry" ... Company is developing a unique project called MabNext ... a number of innovative drugs based on monoclonal antibodies ... took place at the International Exhibition "Innoprom 2014" in ...
(Date:7/10/2014)... July 10, 2014 Research and Markets ... the "International Photonic Integrated Circuit (Monolithic Integration, ... 2019" report to their offering. ... concept of photonic integration traces its roots in ... promise of photonic integration went unexplored and unfulfilled ...
(Date:7/10/2014)... fight against terrorism with the creation of a sensor ... use of light and special glass fibres. , Published ... , the researchers describe a novel optical fibre sensor ... 6.3 ppm (parts per million). It requires an analysis ... detection has involved looking for metals that encase them ...
(Date:7/10/2014)... extremely challenging because there are many genetic variants that ... Now investigators reporting in the July 3rd issue of ... describe a strategy that may help reveal how such ... environmental exposures to affect the development of the nervous ... predispose individuals to schizophrenia. , The work takes ...
Breaking Biology Technology:Dmitry Medvedev Presented BIOCAD the First National "Industry" Award 2International Photonic Integrated Circuit (Monolithic Integration, Hybrid Integration, Module Integration) Market - Forecasts to 2019 2Detecting trace amounts of explosives with light 2New strategy could uncover genes at the root of psychiatric illnesses 2
... Robotic cars attracted attention last decade with a 100-mile driverless ... put up by the U.S. government. The past ... microrobots, miniaturized mobile machines designed to perform specific tasks. And ... some think the time has come for a microrobotics challenge. ...
... CASTRES, France , July 2, 2010 Olivier ... Pierre Fabre,Group starting September 1, 2010 . , ... Until now, Olivier Bohuon , 51, ... such, he ran the,group,s entire pharmaceutical activities from Chicago ( $22 ...
... ... progenitors into specific T cell lineages to the activity of a single gene encoding a ... for the development of blood cells lineages. , ... (PRWeb UK) July 1, 2010 -- A research team in Japan has ...
Cached Biology Technology:Thermal-powered, insect-like robot crawls into microrobot contenders' ring 2Thermal-powered, insect-like robot crawls into microrobot contenders' ring 3Olivier Bohuon Joins Pierre Fabre 2The Last Checkpoint to T Cell Fate 2
(Date:7/11/2014)... available in German . ... that uses the refraction of X-rays through a specimen ... with this method are often of much higher quality ... team of Prof. Franz Pfeiffer are particularly interested in ... including X-ray phase-contrast imaging. One main goal is ...
(Date:7/11/2014)... at the National Institute of Standards and Technology ... work more effectively, they often prove that necessity ... the case recently for M. Lorna De Leoz ... growing specialization of glycomics. Glycomics is the study ... that are attached to proteins and lipids and ...
(Date:7/11/2014)... 2014, Shenzhen, China Researchers from Salk Institute for ... first time evaluated the safety and reliability of ... developed a new method, TALEN-HDAdV, which could significantly ... cell (hiPSC). This study published online in ... foundation for stem cell-based gene therapy. , The ...
Breaking Biology News(10 mins):New simple setup for X-ray phase contrast 2A new genome editing method brings the possibility of gene therapies closer to reality 2
... Health (NIMH), part of the National Institutes of Health, ... social behavior in humans--one of the most important but ... reported in Nature Neuroscience, published online on July 10, ... volunteers to those with a genetic abnormality, Williams Syndrome, ...
... Academy of Sciences (CAS) and the Danish Committee of ... release of pig genomic sequences. The released sequence data ... different domestic pig breeds from Europe and China. The ... genome sequencing effort, the Sino-Danish Pig Genome Project, started ...
... truckers and college students pulling all-nighters, appears to do ... is one of several in a new study that ... the modulation of sleep, wake, and arousal states. , ... colleagues at The Neurosciences Institute in San Diego. , ...
Cached Biology News:Scientists uncover new clues about brain function in human behavior 2Scientists uncover new clues about brain function in human behavior 3‘Blue Brain?project explores thought at molecular level 2