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

CAMBRIDGE, Massachusetts, February 24, 2010 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces it has received Fast Track designation from the FDA for REPLAGAL(R) (agalsidase alfa), its enzyme replacement therapy for Fabry disease.

Shire filed a BLA for REPLAGAL in December 2009. The FDA requested additional human pharmacokinetic data to confirm comparability between product that was manufactured in roller bottles, and that which is manufactured in bioreactors. Product made by the bioreactor process is already approved for commercial use in the European Union as well as a number of other countries.


'/>"/>
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:8/29/2014)... Due to a misstatement posted by the ... Stem Cell Technology Center, LLC ( ASCTC ) was reported ... research that might benefit ALS patients. Because of ASCTC's ... cell technologies and therapeutic applications, FRC listed ASCTC as one ... donors who wish not to support research that requires the ...
(Date:8/28/2014)... August 28, 2014 Best Sanitizers, Inc., ... the food processing industry, is asking industry professionals to ... comparison of the E2 soap they’re currently using to ... Soap . Hand hygiene is critical to fighting ... processing environment. Six key criteria are identified to evaluate ...
(Date:8/28/2014)... spintronics, an electronic which is not only based ... their spin and the spin-related magnetism. Spin-charge converters ... and vice versa. Recently, the research group of ... at Johannes Gutenberg University Mainz in collaboration with ... for the first time realised a new, efficient ...
(Date:8/28/2014)... ATLANTA , Aug. 28, 2014   SunTrust ... of three industry veterans to its equity research ... "Our ongoing expansion in equity research demonstrates ... with unique insights to enhance their investment decision ... Equities at STRH.  "We continue to make significant ...
Breaking Biology Technology:The Adult Stem Cell Technology Center, LLC Declines ALS Ice Bucket Challenge Donors Wishing to Support Ethical Research for New Stem Cell Therapies 2The Adult Stem Cell Technology Center, LLC Declines ALS Ice Bucket Challenge Donors Wishing to Support Ethical Research for New Stem Cell Therapies 3Best Sanitizers, Inc. Asks Food Industry Professionals: With Fall Harvest On the Way, Is Your E2 Hand Soap Up to the Task? 2A new, tunable device for spintronics 2A new, tunable device for spintronics 3SunTrust Robinson Humphrey Expands Equity Research in Healthcare and Energy 2SunTrust Robinson Humphrey Expands Equity Research in Healthcare and Energy 3
... - illumin8 Combines Scientific Content From ... Intelligent Web Search Technology to,Address Complex Technology and ... Elsevier, the world,s leading publisher ... announced the European availability of,illumin8 ( http://www.illumin8.com ), ...
... of Chemistry at the University of Helsinki and ... agreement. ASM Microchemistry Ltd. is a subsidiary of ... based in the Netherlands. The new agreement is ... project started in 2004 and includes research funding ...
... seekers in targeted industries and geographic markets. , ... ... job board company, onTargetjobs Inc. (OTJ), has announced new ... reach beyond focused industries and into specific, geographically localized markets. , ...
Cached Biology Technology:Elsevier Introduces Breakthrough Technology Intelligence Solution for Accelerating R&D and Innovation in Europe 2Elsevier Introduces Breakthrough Technology Intelligence Solution for Accelerating R&D and Innovation in Europe 3Elsevier Introduces Breakthrough Technology Intelligence Solution for Accelerating R&D and Innovation in Europe 4University of Helsinki and ASM International renew research agreement on atomic layer deposition 2onTargetjobs Offers Employers New Recruitment Solutions to Reach Local Career Candidates 2
(Date:8/28/2014)... A new study reports that an expansion of marine ... perform key ecological functions. According to investigators from ... at protecting fish have focused on saving the largest ... species that provide key and difficult-to-replace ecological functions. ... are performed by fish species that also are food ...
(Date:8/28/2014)... (Maximizing Access to Research Careers) Program has announced the ... Genetics from October 18 22, 2014 in San ... the entry of students, post doctorates and scientists from ... community and to encourage the participation of young scientists ... year MARC conferred 16 awards totaling $29,600., The FASEB ...
(Date:8/28/2014)... Bethesda, MD FASEB MARC (Maximizing Access to ... recipients for the Genetics Society of America,s 27th ... October 3, 2014 in Pacific Grove, California. ... entry of students, post doctorates and scientists from ... science community and to encourage the participation of ...
Breaking Biology News(10 mins):Study finds marine protected areas inadequate for protecting fish and ocean ecology 2
... first time in Germany that healthy ovarian tissue has been ... after cancer therapy. The patient is now 32 years old ... described by Ralf Dittrich and his colleagues from Erlangen University ... Arztebl Int 2008; 105[15]: 274-8). Anal carcinoma was diagnosed ...
... . , The President of the Deutsche Forschungsgemeinschaft ... the decision by the German Federal Parliament on the ... and grateful for the decision taken by Parliament. We ... contributed towards the critical debate of the issue. ...
... of electrical and computer engineering at McMaster University, ... for his work in electrical, electronic and communications ... outstanding scientists and scholars whose fundamental discoveries, new ... on their own discipline and who are expected ...
Cached Biology News:McMaster University engineering professor receives Humboldt Research Award 2