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

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:8/22/2014)... The AMA is pleased to share with the ... Alaska Governor Sean Parnell has signed House Bill 255 ... of Unmanned Aircraft Systems and the continuation of the ... it is, “An Act relating to unmanned aircraft systems; ... system.” It defines State of Alaska laws regarding data ...
(Date:8/21/2014)... Aug. 21, 2014  BioSpecifics Technologies Corp. (NASDAQ: ... first in class collagenase-based products marketed as XIAFLEX ... the U.S. and XIAPEX ® in the ... a randomized, double-blind Phase 2a study of CCH ... fibrosclerotic panniculopathy. The results showed that all three ...
(Date:8/21/2014)... 2014 2014 Deep Research ... a professional and in-depth research report on ... basic Seaweed Fertilizer information, including Seaweed Fertilizer ... as well as industry overview. This research ... market as well as global industry analysis ...
(Date:8/21/2014)... Rochelle, N.Y. (PRWEB) August 21, 2014 ... is the first private college in the Mid-Hudson Region ... College will now begin accepting applications from qualified “high-technology” ... , “We are very pleased to have been selected ... support Governor Cuomo’s transformative initiative to stimulate economic development ...
Breaking Biology Technology:State of Alaska Signs Unmanned Aircraft Systems Bill 2BioSpecifics Technologies Corp. Announces Positive Data from Phase 2a Study of CCH for Treatment of Cellulite 2BioSpecifics Technologies Corp. Announces Positive Data from Phase 2a Study of CCH for Treatment of Cellulite 3BioSpecifics Technologies Corp. Announces Positive Data from Phase 2a Study of CCH for Treatment of Cellulite 4BioSpecifics Technologies Corp. Announces Positive Data from Phase 2a Study of CCH for Treatment of Cellulite 5Internationals Seaweed Fertilizer Industry 2014 Development Trend Analysis in New Research Study at DeepResearchReports.com 2Internationals Seaweed Fertilizer Industry 2014 Development Trend Analysis in New Research Study at DeepResearchReports.com 3The College of New Rochelle Becomes First Private College in Mid-Hudson Region to Earn START-UP NY Designation 2The College of New Rochelle Becomes First Private College in Mid-Hudson Region to Earn START-UP NY Designation 3
... Caliper Life,Sciences, Inc. (Nasdaq: CALP ) today ... Small and Mid Cap Growth Conference in Naples, ... 4:40 p.m. EST. Kevin,Hrusovsky, President and CEO of ... business. The live webcast can be accessed at, ...
... Candidate Represents Potential New Short-Course Treatment Option for ... Serious Gram-Positive Skin Infections, Including MRSA, CAMBRIDGE, ... TARG ) announced today that it has,submitted a ... and Drug,Administration (FDA) for its lead antibiotic candidate, ...
... PROENCY will provide real-world clinical data on the ... Boston Scientific,Corporation (NYSE: BSX ) today announced ... PROENCY (PROMUS(TM), ENdeavor(R) and CYpher(R)) European,registry. The registry ... It will collect real-life clinical outcome data for ...
Cached Biology Technology:Targanta Submits Oritavancin New Drug Application 2Targanta Submits Oritavancin New Drug Application 3Targanta Submits Oritavancin New Drug Application 4Boston Scientific Announces Start of Major European Registry Assessing Different Olimus-Eluting Stents 2Boston Scientific Announces Start of Major European Registry Assessing Different Olimus-Eluting Stents 3Boston Scientific Announces Start of Major European Registry Assessing Different Olimus-Eluting Stents 4
(Date:8/22/2014)... , August 22, 2014 /PRNewswire/ ... http://www.researchandmarkets.com/research/mtm27l/biometrics_market ) has announced the addition ... America 2014-2018"  report to their offering.  ... , ,Biometrics is a technology that ... based on their physical or behavioral ...
(Date:8/22/2014)... Thomson Reuters , a leading source of information ... the University of California, Riverside in its 2014 list ... our times." , To generate the list, the company ... researchers whose published work has had enormous impact. , ... 3,200 individuals who published the greatest number of highly ...
(Date:8/22/2014)... at the 29th Annual International Papillomavirus Conference shows ... Inc. combats three types of human papillomavirus, including ... cervical cancer. , When tested in several cultured ... HPV-16, HPV-18 and HPV-11 cells, according to Louise ... presented the findings at the Seattle conference. The ...
Breaking Biology News(10 mins):Biometrics Market in North America 2014-2018: Key Vendors are 3M Cogent, Cross Match, NEC and Safran SA 2Biometrics Market in North America 2014-2018: Key Vendors are 3M Cogent, Cross Match, NEC and Safran SA 35 UC Riverside scientists among world's most influential scientific minds 2
... University scientist Chittaranjan Kole was awarded the Outstanding Crop ... He was one of three scientists to receive the ... the field of crop science. He also chaired a ... this month, "Genomics and Breeding of Climate Resilient ...
... out of research conducted on the edge of the ... Gorge in Tanzania since that produced by Louis and ... special issue of the prestigious Journal of Human ... the Bernard Price Institute for Palaeontological Research, and Professor ...
... consumer products such as shampoos, gels, hair dyes and ... food crops, as reported in a paper in the ... of Sciences . Manufactured nanomaterials are man-made materials ... scale. Their effects on human health and the environment ...
Cached Biology News:Dawn of humanity illuminated in special journal edition 50 years after the Leakeys 2Soybeans susceptible to man-made materials in soil 2Soybeans susceptible to man-made materials in soil 3
... Simultaneously perform 96 assays on four ... four microarray slides with 96 (6mm x ... protein, gene expression, or screening analysis studies. ... compression fit gasket, eliminating the presence of ...
... is an automated multiplexing platform that uses ... pathogen sequence detection and pharmacogenetics applications. Multiple ... to an open and flexible electronic microarray, ... until all tests sites have been utilized. ...
... with sequence siTrio siRNA --- a ... target gene of interestis our most popular product. ... 75% knockdown of your target gene when used ... and confirmation of optimal transfection with one of ...
The Bio-Plex Manager version 3.0 to 4.0 workstation software upgrade kit is used to upgrade existing Bio-Plex Manager version 3.0 software to version 4.0 security edition software....
Biology Products: