Cladribine News and Research

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MS Awareness Week: Time for nation to go orange and move it to end MS

MS Awareness Week March 8-14 is the time for the nation to go orange and move it to end multiple sclerosis, a disease where someone is newly diagnosed every hour of every day. Supported by a Congressional resolution, this year MS Awareness Week and the state of MS research aptly coincide. Move it to create a world free of MS!

8 Mar 2010

EMD Serono announces results from CLARITY Phase III trial in MS patients

EMD Serono, an affiliate of Merck KGaA, Darmstadt, Germany, announced today the online publication of the results from the CLARITY Phase III trial using Cladribine Tablets (EMD Serono's proprietary investigational oral formulation of cladribine) in The New England Journal of Medicine. The CLARITY study was a two-year (96-week), randomized, double-blind, placebo-controlled Phase III trial of Cladribine Tablets in 1,326 people with relapsing-remitting multiple sclerosis (MS).

21 Jan 2010

BioTrends Research Group releases Wave One LaunchTrends: EXTAVIA report

BioTrends Research Group, Inc. announces the release of the Wave One LaunchTrends(®): EXTAVIA report. The survey was completed by U.S. Neurologists Extavia (Interferon beta 1b).

12 Jan 2010

New Sermo Event Report assesses physicians' perception of multiple sclerosis drugs

Sermo (http://www.sermo.com), the world's largest online physician's community, today announced a new Sermo Event(TM) Report assessing physician perception of FDA's "refuse to file" (RTF) letter on EMD Serono's Cladribine tablets and its potential impact, if any, on Novartis' oral MS agent in development; Fingolimod. Cladribine is expected to be one of the first oral agents to be approved for the treatment of relapsing and remitting multiple sclerosis.

7 Jan 2010

Oral cladribine to be the first oral disease-modifying multiple sclerosis therapy despite receiving RTF letter

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that a recent "refuse to file" (RTF) letter issued by the Food and Drug Administration (FDA) regarding Merck Serono's oral cladribine has heightened the competition between oral cladribine and its primary competitor, Novartis/Mitsubishi Tanabe's FTY-720 (fingolimod), to be the first oral disease-modifying multiple sclerosis therapy to reach the market in the United States.

6 Jan 2010

National MS Society calls for grant applications to examine the impact of CCSVI hypothesis

2009 saw exciting research progress, unprecedented opportunities on the horizon, and more scientists than ever working on resolving important questions. Despite the year's economic and financial challenges, the National Multiple Sclerosis Society continues to propel research forward to end MS. In 2009 the Society provided over $33.5 million to support 345 new and ongoing projects in its research portfolio, plus $1.5 million for Fast Forward, the Society's drug development subsidiary which continues to attract new funding streams.

23 Dec 2009

Results of preclinical studies evaluating AC220 to be presented at ASH annual meeting

Ambit Biosciences Corporation announced today the presentation of two posters presenting the results of preclinical studies evaluating AC220 at the 51st Annual Meeting of the American Society of Hematology (ASH) in New Orleans.

8 Dec 2009

Refuse to file letter on NDA for Cladribine Tablets issued to EMD Serono

EMD Serono, an affiliate of Merck KGaA, Darmstadt, Germany, announced today that it received a refuse to file letter from the US Food and Drug Administration (FDA) on the New Drug Application (NDA) for Cladribine Tablets, EMD Serono's proprietary investigational oral formulation of cladribine, as a therapy for relapsing forms of multiple sclerosis (MS).

1 Dec 2009

EMD Serono submits NDA for Cladribine Tablets in the U.S.

EMD Serono, Inc. an affiliate of Merck KGaA, Darmstadt, Germany, announced today the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Cladribine Tablets, EMD Serono's proprietary investigational oral formulation of cladribine, as a therapy for reducing relapses in people with relapsing forms of multiple sclerosis (MS).

1 Oct 2009

Neurologists recommend oral cladribine for treating multiple sclerosis

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, owing to its infrequent dosing and positive efficacy, nearly 90 percent of surveyed neurologists indicate they will prescribe Merck Serono/EMD Serono's oral cladribine for the treatment of multiple sclerosis.

11 Sep 2009

Giving children access to drug clinical trials is crucial, clofarabine approval shows

The accelerated approval of the drug clofarabine to treat relapsed or refractory pediatric acute lymphoblastic leukemia (ALL) demonstrates the importance of offering children rapid access to new treatments through clinical trials, according to investigators at St. Jude Children's Research Hospital. Refractory or relapsed ALL is a disease that resists treatment.

2 May 2005

FDA approval for Cladribine to treat active Hairy Cell Leukemia

American Pharmaceutical Partners, Inc. today announced it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Cladribine Injection.

27 Apr 2004

Cladribine Targeted to Become First Oral Therapy for Multiple Sclerosis

Serono and IVAX Corporation has announced positive results from two clinical trials with a new proprietary oral formulation of cladribine, a potential new treatment for multiple sclerosis (MS). The study results showed that the formulation of oral cladribine which has been developed by Serono and IVAX has met the targets for an orally administered product, with blood levels of cladribine in the expected therapeutic range. Efficacy studies of oral cladribine in MS patients are planned to start late 2004.

23 Mar 2004

New therapy for multiple sclerosis sufferers

Serono and IVAX Corporation have announced positive results from two clinical trials with a new proprietary oral formulation of cladribine, a potential new treatment for multiple sclerosis (MS).

23 Mar 2004