Navigation Links
EMD Serono Receives Complete Response Letter From FDA on Cladribine Tablets New Drug Application
Date:3/2/2011

dies are expected by the end of 2011. Top-line results from the ONWARD(3) study are expected in the first half of 2012.

Cladribine Tablets are approved and available under the trade name Movectro® in Australia and Russia as a treatment of relapsing-remitting MS and are under regulatory review in other countries.(1) CLARITY: CLAdRIbine Tablets treating MS orallY(2) ORACLE MS: ORAl CLadribine in Early MS(3) ONWARD: Oral Cladribine added oN to interferon beta-1a in patients With Active Relapsing DiseaseAbout Cladribine TabletsEMD Serono's oral formulation of cladribine (Cladribine Tablets) is an investigational treatment for patients with relapsing forms of multiple sclerosis (MS). Cladribine is a small molecule that may interfere with the behavior and the proliferation of certain white blood cells, particularly lymphocytes, which are thought to be involved in the pathological process of MS. Cladribine Tablets were approved in Russia in July 2010 and in Australia in September 2010 as a treatment of relapsing-remitting MS and are under regulatory review in other countries.

The clinical development program for Cladribine Tablets includes:

- The CLARITY (CLAdRIbine Tablets treating MS orallY) study and its extension: a two-year Phase III placebo-controlled trial designed to evaluate the efficacy and safety of Cladribine Tablets as a monotherapy in patients with relapsing-remitting MS and the CLARITY EXTENSION two-year Phase III study designed to provide data on the long-term safety and efficacy of extended administration of Cladribine Tablets for up to four years.

- The ORACLE MS (ORAl CLadribine in Early MS) study: a two-year Phase III placebo-controlled trial designed to evaluate the efficacy and safety of Cladribine Tablets as a monotherapy in patients at risk of developing MS (patients who have experienced a first clinical event suggestive of MS). This trial was announced in September 2008.

- The ONWARD (Oral Cladribine added o
'/>"/>

SOURCE EMD Serono, Inc.
Copyright©2010 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3 4

Related biology technology :

1. EMD Serono Named as a Top Employer by Science Magazine
2. Merck Serono Named as a Top Employer by Science Magazine
3. Michael J. Fox Foundation Awards $2 Million Grant From EMD Serono to Research Projects on Cognitive Deficits in Parkinsons Disease
4. EMD Serono Launches Landmark Patient Registry for Egg Freezing
5. Merck Serono Launches Strategic Venture Capital Fund
6. Oncothyreon announces temporary suspension of Stimuvax clinical trials by Merck Serono
7. Serono Symposia International Foundation (SSIF) Launches a New Web Site Dedicated to Medical Education on Phenylketonuria (PKU)
8. Medicsight Receives Brazilian State Food and Drug Administration Approval for ColonCAD Software
9. Angiotech receives CE Mark approval of HemoStream(TM) Chronic Dialysis Catheter
10. SGX - Lilly Merger Offer Receives Positive Opinions From Proxy Advisory Firms
11. CV Therapeutics Receives European Approval for the Brand Name Ranexa(R)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/18/2013)... June 18, 2013 The Regulatory ... of two new offices in Asia—one in Singapore and ... serve as RAPS’ Pan-Asia office , serving the ... more focused on audiences within China. , The announcement ... partnership with five Singapore government agencies to develop and ...
(Date:6/18/2013)... Wilmington, DE (PRWEB) June 18, 2013 ... teachers to the 11th annual DuPont National AgriScience Teachers ... Chesapeake Farms in Chestertown, Md. , ... sponsored by DuPont and is a special project of ... National Association of Agricultural Educators (NAAE) . The ...
(Date:6/18/2013)... 18, 2013 The Pistoia ... the HELM biomolecular representation standard software toolkit and ... HELM (Hierarchical Editing Language for Macromolecules) ... biomolecules (e.g. proteins, nucleotides, antibody drug conjugates) whose ... informatics methodologies impractical or unusable. HELM solves this ...
(Date:6/18/2013)... 2013  AMRI (NASDAQ: AMRI ) ... , site has received approval to expand ... to handle Schedule 2 and 2N controlled substances. ... Burlington,s physical security and quality ... (Logo: http://photos.prnewswire.com/prnh/20120229/NY61160LOGO ) With ...
Breaking Biology Technology:RAPS Opens Offices in Singapore and China 2RAPS Opens Offices in Singapore and China 3DuPont Sponsors National AgriScience Ambassador Academy 2DuPont Sponsors National AgriScience Ambassador Academy 3The Pistoia Alliance Releases HELM Biomolecular Representation Standard Open Source Tools 2AMRI Burlington Receives DEA Approval to Handle Controlled Substances 2
... physicians and scientists from institutions around the world such ... Control and the National Institutes of Health will meet ... Hygienes Annual Meeting on Nov. 4-8, in Philadelphia to ... and global health threats. , Highlights include: , ...
... (Nasdaq: HGSI ) today announced that it will ... the quarter ended,September 30, 2007. These results are expected ... http://www.newscom.com/cgi-bin/prnh/20010612/HGSLOGO ) The conference call will be ... November 1, 2007, at 11:00 am Eastern Time. ...
... PITTSBURGH, Oct. 24 The Pittsburgh Life ... region,s life,sciences industry on a fast track ... $115,000 in Innovention Technologies, LLC, a developmental-stage,medical ... and commercialize a,highly-maneuverable surgical probe that will ...
Cached Biology Technology:Specialists in infectious disease and global health convene at Philadelphia meeting 2Human Genome Sciences To Sponsor Conference Call To Discuss Third Quarter 2007 Financial Results 2The PLSG Invests $115,000 in Innovention Technologies, LLC 2
(Date:6/18/2013)... chemical modification of DNA and this modification can ... sequence. Until now, scientists believed that this epigenetic ... Today, a team of researchers from the University ... Louis-Jeantet Professor at the Faculty of Medicine, reveals ... that DNA methylation may play both a passive ...
(Date:6/17/2013)... in the U.S. exposed to high levels of air pollution ... a child with autism as women who lived in areas ... School of Public Health (HSPH). It is the first large ... across the U.S. , "Our findings raise concerns since, depending ... our study lived in areas where risk of autism was ...
(Date:6/17/2013)... An international team led by scientists at The Scripps ... Albert Einstein College of Medicine of Yeshiva University has ... the tuberculosis (TB) bacterium in two different ways. , ... of the major global health crises of our timethe ... Peter G. Schultz, the Scripps Family Chair Professor of ...
Breaking Biology News(10 mins):The secret of DNA methylation 2Exposure to high pollution levels during pregnancy may increase risk of having child with autism 2New compound excels at killing persistent and drug-resistant tuberculosis 2New compound excels at killing persistent and drug-resistant tuberculosis 3New compound excels at killing persistent and drug-resistant tuberculosis 4
... plants can inadvertently get transported with them, resulting in new ... Such invasions of exotic species can occur rapidly, taking over ... weeds and invasive plants develop and interact in their new ... addressed in a newly revised book, Ecology of Weeds ...
... ISIS Second Target Station at the Rutherford Appleton Laboratory ... project in the UK, it is on time and ... addition to the existing ISIS facility which supports an ... for research in physics, chemistry, materials science, geology, engineering ...
... latest American Chemical Society (ACS) News Service Weekly press ... journals and Chemical & Engineering News. With more than ... Please cite the individual journal, or the American Chemical ... ARTICLE #1 FOR IMMEDIATE RELEASE ...
Cached Biology News:Book on weeds and invasive plants discusses how to manage them using ecological approaches 2Book on weeds and invasive plants discusses how to manage them using ecological approaches 3Building blocks of life 2American Chemical Society's Weekly PressPac -- Sept. 26, 2007 2American Chemical Society's Weekly PressPac -- Sept. 26, 2007 3American Chemical Society's Weekly PressPac -- Sept. 26, 2007 4American Chemical Society's Weekly PressPac -- Sept. 26, 2007 5American Chemical Society's Weekly PressPac -- Sept. 26, 2007 6American Chemical Society's Weekly PressPac -- Sept. 26, 2007 7American Chemical Society's Weekly PressPac -- Sept. 26, 2007 8
... Translation Detection Systems allow non-radioactive detection ... these systems, biotinylated lysine residues are ... eliminating the need for labeling with ... This biotinylated lysine is added to ...
...
... your microarray data using Asuragens bioinformatics ... need from consultation to extensive data ... date methods. Utilize our expertise in ... Service or from your own microarray ...
... Maximize the value of your microarray data ... support you need from consultation to extensive ... date methods. Utilize our expertise in combination ... from your own microarray experiments., ,Normalization and ...
Biology Products: