Dive into the archives.
- FDA Grants Cladribine Priority Review
July 28 (Bloomberg) — Merck KGaA said U.S. regulators granted the cladribine multiple sclerosis pill priority review, reducing to six months from 10 the time it will take the Food and Drug Administration to decide on approval. The regulator is expected to rule on the treatment in the fourth quarter, the Darmstadt-based maker of drugs [...]
- EX-US: First Oral Approved for PWMS: Cladribine approved in RUSSIA
Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that the Russian Federal Service on Surveillance in Healthcare and Social Development has become the first government agency to grant marketing approval to Cladribine Tablets for the treatment of relapsing-remitting multiple sclerosis (MS). Cladribine Tablets will be available in Russia under the trade name [...]
- Merck Refiles Cladribine for US Approval
FRANKFURT (Dow Jones)–German pharmaceutical and chemicals company Merck KGaA (MRK.XE) said Tuesday it resubmitted its application for U.S. regulatory approval of oral multiple sclerosis treatment cladribine–seven months after the Food and Drug Administration rejected its initial submission.
- 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 [...]
- Merck Discontinues Ph 2 Trial of Atacicept in MS
September 28, 2009 by Matthew Dennis Merck KGaA has decided to discontinue Phase II clinical trials of atacicept for the treatment of multiple sclerosis based on a recommendation from a data monitoring panel, according to ZymoGenetics. The panel observed an increase in disease activity in patients receiving the drug compared to those administered placebo in one [...]
