Navigation Links
Repligen Receives Orphan Drug Designation from the FDA for RG2833 for Friedreich's Ataxia
Date:5/24/2010

WALTHAM, Mass., May 24 /PRNewswire-FirstCall/ -- Repligen Corporation (Nasdaq: RGEN) announced today that the Office of Orphan Products Development of the Food and Drug Administration (FDA) has granted orphan drug designation to RG2833, a selective histone deacetylase 3 (HDAC-3) inhibitor for the treatment of Friedreich's ataxia.  Orphan drug designation qualifies Repligen to receive seven years of marketing exclusivity in the United States if the company is the first to obtain marketing approval for RG2833 for the treatment of Friedreich's ataxia.  This designation may also qualify Repligen to benefit from certain tax credits and a waiver of the company's obligation to pay the FDA application user fees for this product as required by the Prescription Drug User Fee Act. The U.S. Orphan Drug Act provides incentives for companies developing and marketing therapies for rare diseases, defined as those affecting fewer than 200,000 Americans.  There are approximately 15,000 people worldwide with Friedreich's ataxia.

"We are very pleased to receive Orphan Drug Designation for our Friedreich's ataxia program," stated Walter C. Herlihy, President and Chief Executive Officer of Repligen.  "RG2833 is the first compound that targets activation of the defective gene responsible for Friedreich's ataxia.  If this approach is successful, it has the potential to significantly impact patients' lives."

Earlier this month, we filed an Investigational New Drug Application with the FDA for a Phase 1 study of RG2833 to evaluate the pharmacokinetic and safety profile of RG2833 in up to 40 healthy volunteers.  This study will also evaluate the phar
'/>"/>

SOURCE Repligen Corporation
Copyright©2010 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3 4

Related biology technology :

1. Repligen Announces Conference Call of Third Quarter Fiscal Year 2008 Results
2. Repligen Announces Settlement with Bristol-Myers Squibb in Orencia(R) Lawsuit
3. Repligen Reports Fourth Quarter and Fiscal Year 2008 Financial Results
4. Repligen Announces Conference Call of First Quarter Fiscal Year 2009 Results
5. Repligen Receives Research Grants to Support Friedreichs Ataxia Development Program
6. Repligen Announces Publication of Positive Results with Proprietary HDAC Inhibitor in Huntingtons Disease Model
7. Repligen to Present at the 2008 UBS Global Life Sciences Conference Wednesday, September 24th, 1:00 p.m. EDT
8. Repligen to Present at the Rodman & Renshaw 10th Annual Healthcare Conference Monday, November 10th, 4:55 p.m. EST
9. Repligen Announces Conference Call of Third Quarter Fiscal Year 2009 Results
10. Repligen to Present at the BIO CEO & Investor Conference Monday, February 9th, 11:30 a.m. EST
11. Repligen Reports Third Quarter Fiscal Year 2009 Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/20/2013)... , May 20, 2013 Pacific Biomarkers and ... solutions for developers of biosimilars at the 2013 ... Sheraton San Diego Hotel and Marina ... will have the opportunity to speak with company representatives ... Paths That Cross" on May 21 from 1-2 p.m. ...
(Date:5/20/2013)... NY (PRWEB) May 20, 2013 With bed ... Products said that although bed bugs need to be eliminated, ... will not compromise a person's health. And so to help ... how to get rid of bed bugs without ... non-pesticide bed bug spray it called Bed Bug Bully. , ...
(Date:5/20/2013)... BALTIMORE , May 20, 2013 ... regional private-public partnership focusing on commercializing market-relevant biohealth ... Central Maryland , today announced ... the first Entrepreneur-in-Residence (EIR) for BHI at the ... Lung and Blood Institute (NHLBI). Dr. Aiyar ...
(Date:5/20/2013)... , May 20, 2013 Cempra, ... on developing differentiated antibiotics to meet critical medical ... announced that it presented data at the American ... Philadelphia demonstrating the antibacterial and ... Cempra,s prior Phase 2 clinical trial in outpatients ...
Breaking Biology Technology:Pacific Biomarkers and Clinigene International To Announce Laboratory Solutions for Developers of Biosimilars at 2013 AAPS/ National Biotechnology Conference 2New Non Pesticide Discovery on How to Get Rid of Bed Bugs Tipped by My Cleaning Products 2BioHealth Innovation, Inc. Names Ram Aiyar as Entrepreneur-in-Residence to NIH National Heart, Lung and Blood Institute 2BioHealth Innovation, Inc. Names Ram Aiyar as Entrepreneur-in-Residence to NIH National Heart, Lung and Blood Institute 3BioHealth Innovation, Inc. Names Ram Aiyar as Entrepreneur-in-Residence to NIH National Heart, Lung and Blood Institute 4Cempra Presents Post-Phase 2 Analysis of Solithromycin's Efficacy and Safety Results from Patients with Community Acquired Bacterial Pneumonia (CABP) 2
... XIANYANG, China, Aug. 12 /PRNewswire-Asia-FirstCall/ ... or "the Company"),a Xianyang-based developer, manufacturer and supplier ... of diseases and conditions,today announced that management will ... quarter at 10:30 a.m. EDT on Friday, August ...
... team of researchers from the Netherlands, Russia and ... set the mobility in self-assembled monolayer field-effect transistors ... chemical sensors that can be produced in a ... Research Eindhoven and Eindhoven University of Technology. The ...
... , , SAN MARINO, ... researcher for bio technology company Viral Genetics (Pink Sheets: VRAL), will ... Stem Cell Therapy. Her presentation will highlight the potential for combining ... cells to generate the energy needed to repair chemotherapy induced DNA ...
Cached Biology Technology:Biostar Pharmaceuticals, Inc. to Host Fiscal Year 2009 Second Quarter Earnings Conference Call on Friday, August 14, 2009 at 10:30 a.m. EDT 2Biostar Pharmaceuticals, Inc. to Host Fiscal Year 2009 Second Quarter Earnings Conference Call on Friday, August 14, 2009 at 10:30 a.m. EDT 3Mysterious charge transport in self-assembled monolayer transistors unraveled 2Viral Genetics Scientist Presents Potential New Treatment for Drug Resistant Brain Tumors at Aspen Symposium 2Viral Genetics Scientist Presents Potential New Treatment for Drug Resistant Brain Tumors at Aspen Symposium 3
(Date:5/20/2013)... University of Bristol and published online today in the ... how the brain and inner ear developed in dinosaurs. ... Sciences, together with Tom Hbner from the Niederschsische Landesmuseum ... year old dinosaurs. , The two palaeontologists studied different ... a very young (juvenile) individual of approximately three ...
(Date:5/20/2013)... New Geology articles posted online ... cover a wide swath of geoscience subdisciplines, including ... and paleobotany. Locations studied include Siberia; the Sumatran ... Apuane, Italy; Ukraine; Mars; and the Southeastern U.S. ... Rubies, jadeite, and plate tectonics;, 2. The clear ...
(Date:5/19/2013)... study reports that white men and women of European ... valgus) and lesser toe deformities, including hammer or claw ... estimate the heritability of foot disorders in humansappear in ... by Wiley on behalf of the American College of ... many as 60% of older adults have foot disorders ...
Breaking Biology News(10 mins):Fossil brain teaser 2New in GEOLOGY: Gems, Darwin, Mars, Hemp, Snowball Earth, a Siberian Impact Crater, and More 2New in GEOLOGY: Gems, Darwin, Mars, Hemp, Snowball Earth, a Siberian Impact Crater, and More 3New in GEOLOGY: Gems, Darwin, Mars, Hemp, Snowball Earth, a Siberian Impact Crater, and More 4New in GEOLOGY: Gems, Darwin, Mars, Hemp, Snowball Earth, a Siberian Impact Crater, and More 5New in GEOLOGY: Gems, Darwin, Mars, Hemp, Snowball Earth, a Siberian Impact Crater, and More 6New in GEOLOGY: Gems, Darwin, Mars, Hemp, Snowball Earth, a Siberian Impact Crater, and More 7New in GEOLOGY: Gems, Darwin, Mars, Hemp, Snowball Earth, a Siberian Impact Crater, and More 8New in GEOLOGY: Gems, Darwin, Mars, Hemp, Snowball Earth, a Siberian Impact Crater, and More 9New in GEOLOGY: Gems, Darwin, Mars, Hemp, Snowball Earth, a Siberian Impact Crater, and More 10New in GEOLOGY: Gems, Darwin, Mars, Hemp, Snowball Earth, a Siberian Impact Crater, and More 11Blame your parents for bunion woes 2
... the strange, bony crests on the heads of the ... long, convoluted nasal passages that loop up over the ... of Toronto, Ohio University and Montana State University now ... and reconstruct the brains and nasal cavities of four ...
... . Tomislav Domazet-Loo and Diethard Tautz from the ... systematically analysed the time of emergence for a large number ... studies show for the first time that the majority of ... the first cells. The search for further genes, particularly those ...
... grants exceeding $3 million will assist Michigan State ... to turn animal waste into usable heat, electricity ... Digestion Research and Education Center will consolidate new ... south of campus, at MSU,s expanding farm animal ...
Cached Biology News:Key to function of dinosaur crests found in brain structure 2Genetic based human diseases are an ancient evolutionary legacy 2Cost-effective farm waste-to-energy technology focus of research 2Cost-effective farm waste-to-energy technology focus of research 3
Rabbit anti Xanthine Oxidase Xanthine Oxidase, Bovine Buttermilk...
... Kits without ammonium sulfate are compatible with ... as Taq and AmpliThem™™ DNA polymerases. You ... systems in one experiment by adding your ... the PreMixes supplied with the kit. This ...
Application: for RNase- decontamination , Registered Trademark of Ambion. ,Special grade: for molecular biology Density: 1.00 g/mL (20 C) Suitab tst: RNase decontamination in accordance...
Matrix for protein MALDI-MS...
Biology Products: