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:12/24/2014)... 2014 The report expects global cell ... 2019. It also provides a carefully analyzed data about ... for the market. , Full Copy of Report @ ... global market for cell expansion will keep witnessing growth ... this growth to be driven by rapid technological advancements, ...
(Date:12/24/2014)... LOUIS , Dec. 23, 2014 ... today that the waiting period under the Hart-Scott-Rodino ... the acquisition expired on December 22, 2014, thereby ... review requirement for the acquisition of the Company ... U.S. antitrust clearance satisfies another condition to closing ...
(Date:12/22/2014)... , Dec. 22, 2014 /PRNewswire/ - RepliCel Life Sciences ... medicine company focused on the development of autologous cell ... of the University of Calgary in conjunction with co-authors ... which further validates the company,s ongoing clinical research using ... of pattern baldness. The paper entitled " ...
(Date:12/22/2014)... 22, 2014 ITRA Global, one of ... of commercial real estate, has further expanded its global ... Perth and Brisbane, Western Australia, reports Mylinda Vick, CCIM, ... ITRA Global / ACORPP (Australian Corporate Property and ... company providing property services to a wide range of ...
Breaking Biology Technology:The Cell Expansion Market is Expected to Reach $14.8 billion by 2019 - New Research Report by MarketsandMarkets 2The Cell Expansion Market is Expected to Reach $14.8 billion by 2019 - New Research Report by MarketsandMarkets 3Acquisition of Sigma-Aldrich by Merck KGaA, Darmstadt, Germany, Receives U.S. Antitrust Clearance 2Acquisition of Sigma-Aldrich by Merck KGaA, Darmstadt, Germany, Receives U.S. Antitrust Clearance 3Newly Released Peer-Reviewed Publication Further Validates RepliCel's Use of Dermal Sheath Cup Cells to Treat Pattern Baldness 2Newly Released Peer-Reviewed Publication Further Validates RepliCel's Use of Dermal Sheath Cup Cells to Treat Pattern Baldness 3Newly Released Peer-Reviewed Publication Further Validates RepliCel's Use of Dermal Sheath Cup Cells to Treat Pattern Baldness 4Newly Released Peer-Reviewed Publication Further Validates RepliCel's Use of Dermal Sheath Cup Cells to Treat Pattern Baldness 5ITRA Global Continues International Expansion in Perth and Brisbane, Australia 2
...  bioTheranostics, Inc., a bioMerieux company that develops innovative ... introduced a new product line of high medical ... called PRECIS Precision Medicine by bioTheranostics(SM). Precision medicine, ... diagnosis of primary tumor site and predictive biomarkers ...
... 26, 2012 Lend Lease is pleased to announce ... for the Life Sciences group in the Atlantic Region.  ... will be based out of the Raleigh, NC office, working closely ... in the South Atlantic offices. He will report directly ...
... Jan. 25, 2012  DATATRAK International, Inc. (OTCQX: DATA), ... eClinical solutions for the clinical trials industry, today ... Program, Excel Life Sciences (ELS). Excel Life Sciences ... clinical trial and site management services. ...
Cached Biology Technology:bioTheranostics Launches Precision Medicine Biomarkers for Tumor Pathway Interrogation 2bioTheranostics Launches Precision Medicine Biomarkers for Tumor Pathway Interrogation 3Lend Lease Announces the Appointment of Tom Chapman as Director Operations for the Life Sciences Group in the Atlantic Region 2Excel Life Sciences Joins DATATRAK's Connect Partner Program 2Excel Life Sciences Joins DATATRAK's Connect Partner Program 3
(Date:12/11/2014)... DUBLIN , Dec. 09, 2014 Research ... http://photos.prnewswire.com/prnh/20130307/600769 ( http://www.researchandmarkets.com/research/twhjll/biometrics_market ) ... Market in the APAC Region 2015-2019"  report to ... emerging in this market is advances in technology. ... to upgrade biometric solutions to the latest standard ...
(Date:12/10/2014)... 2014 You,ve been here before: you desperately need ... your password, site key or the answer to your secret ... teacher? Today, Hoyos Labs , a ... will finally put an end to the frustration that comes ... . 1U leverages a user,s smartphone to acquire his or ...
(Date:12/10/2014)... , Dec. 08, 2014 Research and Markets ... addition of the "Biometrics Market in Japan ... http://photos.prnewswire.com/prnh/20130307/600769 The ... such as rural banking and upgradation of the ... witnessed in the market. Besides the aforementioned projects, ...
Breaking Biology News(10 mins):Biometrics Market in the APAC Region 2015-2019: Key Vendors are 3M Cogent, NEC, Safran and Suprema 2The Password is Finally Dead: Launch of 1U Mobile App Eliminates Need for All Usernames and Passwords 2The Password is Finally Dead: Launch of 1U Mobile App Eliminates Need for All Usernames and Passwords 3Biometrics Market in Japan 2014-2018: Key Vendors are DDS, Fujitsu, Hitachi and NEC 2
... GAINESVILLE, Fla. Contrary to a widespread assumption, global warming ... malaria control, development and other factors that are at work ... of scientists including two University of Florida researchers in a ... Nature . Scientists and public policy makers have been ...
... New research shows that nearly 1 in 5 cases of ... are caused by not one but multiple strains of the ... of Minnesota Medical School report their findings today in the ... journal published by the American Society for Microbiology. "Koch,s ...
... WASHINGTON -- As part of its most comprehensive study of ... three reports emphasizing why the U.S. should act now to ... adapt to the inevitable impacts of climate change. The ... National Academy of Sciences and National Academy of Engineering, are ...
Cached Biology News:Scientists: Malaria control to overcome disease’s spread as climate warms 2Unexpectedly high rate of multiple strains in fungal infection 2New climate change reports underscore need for action 2New climate change reports underscore need for action 3New climate change reports underscore need for action 4New climate change reports underscore need for action 5
... - Proliferation Marker, prediluted Ki67 antigen ... protein, expressed by proliferating cells in all ... S, G2 and M phase). It is ... are useful in establishing the cell growing ...
Request Info...
Rabbit polyclonal to Aortic Elastin ( Abpromise for all tested applications). entrezGeneID: 2006 SwissProtID: P15502...
Vascular Endothelial Growth Factor C Class: Antibody Product Group: Angiogensis...
Biology Products: