Dive into the archives.
- Merck KGaA Submits Application For Cladribine Tablets In US
Germany’s Merck KGaA has made further progress in its bid to be the first company to market an oral multiple sclerosis treatment by filing cladribine in the USA.
The German company’s US subsidiary EMD Serono has submitted a New Drug Application with the Food and Drug Administration for cladribine as a therapy for reducing relapses in [...]
- Hot off the ECTRIMS Press…Cladribine Reduces Disease Activity in a Big Way
Darmstadt, Germany, September 11, 2009 – Merck KGaA announced today new data from a post-hoc analysis of the two-year (96-week) placebo-controlled CLARITY(1) Phase III trial using a short-course of Cladribine Tablets (the proprietary investigational oral formulation of cladribine) to treat patients with relapsing-remitting multiple sclerosis (MS). The data from this post-hoc analysis of the CLARITY [...]
- Merck Sumbits Cladribine Application for EU Approval
July 23, 2009 — 9:05am ET | By John Carroll
Racing to beat Novartis to the world’s biggest drug markets with a new oral therapy for multiple sclerosis, Merck KGaA has filed for regulatory approval of cladribine in Europe and plans to file in the U.S. later this quarter.
The application brings Merck ”closer to the possibility of providing an [...]
- Hot off the ENS Press: Cladribine Is Safe Overall in Patients With Multiple Sclerosis
MILAN, Italy — June 24, 2009 — According to a safety analysis of a study presented here at the 19th Meeting of the European Neurological Society (ENS), the incidence of treatment-emergent adverse events in the trial was comparable between 2 doses of cladribine and placebo in patients with multiple sclerosis (MS), with exceptions related to [...]
- Hot off the AAN Press: Cladribine Reduces Relapses, Disability, Disease Progression
April 29, 2009
Merck KGaA on Wednesday presented detailed results from a previously announced Phase III study of investigational oral multiple sclerosis drug cladribine at the American Academy of Neurology annual conference. The findings demonstrated that annual short-course treatment with cladribine significantly reduced the rate of clinical relapses, disability progression and brain lesions in patients [...]
- LATE BREAKING: New Phase III Data for Cladribine to be Presented at AAN
CLARITY (CLAdRIbine tablets Treating MS OrallY) Study Data to be Presented as Late-Breaking Oral Presentation
By: PR Newswire
Mar. 30, 2009 08:01 AM
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GENEVA, Switzerland, March 30 /PRNewswire/ — Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that the American Academy of Neurology (AAN) has accepted a late-breaking abstract regarding cladribine tablets, its oral [...]
- The Age of Orals: Who Will Win the Race to the Market?
Jan 23, 2009
Oral Cladribine Reduces MS Relapses in Phase 3 Clinical Trial
Oral cladribine (EMD Serono) reduced the relapse rate significantly more than inactive placebo in the phase 3 “CLARITY” study of 1,326 people with relapsing-remitting MS. These initial results – the first from any phase 3 study of oral therapy for MS — are reported [...]
