Dive into the archives.
- FDA delays ruling on Acorda’s MS drug until 1/2010
October 22, 2009 6:38 AM ET
HAWTHORNE, N.Y. (AP) – Acorda Therapeutics Inc. said Thursday the Food and Drug Administration delayed a ruling on its multiple sclerosis drug candidate Fampridine-SR by three months.
The agency was due to make a decision by Thursday, but the ruling is now due by Jan. 22, 2010.
Acorda said the FDA extended [...]
- Acorda Announces Positive Vote by FDA Advisory Committee for Fampridine-SR
Wed, Oct 14, 2009
* Committee Views Fampridine-SR as Safe, Effective and Clinically Meaningful for
Improving Walking in People with Multiple Sclerosis
* Conference Call Scheduled for Thursday, October 15 at 8:00 a.m. Eastern TimeHAWTHORNE, N.Y.–(Business Wire)–
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced the U.S. Food and Drug
Administration (FDA) Peripheral and Central Nervous System Drugs (PCNSD)
Advisory Committee voted [...]
- Luteolin as a therapeutic option for MS
Multiple sclerosis (MS) remains without an effective treatment in spite of intense research efforts. Interferon-beta (IFN-beta) reduces duration and severity of symptoms in many relapsing-remitting MS patients, but its mechanism of action is still not well understood.
Moreover, IFN-beta and other available treatments must be given parenterally and have a variety of adverse effects. Certain naturally [...]
- Avanir posts mixed late stage Zenvia study results
ALISO VIEJO, Calif. — Avanir Pharmaceuticals Inc. on Friday reported mixed results for its drug candidate Zenvia, which is intended to reduce involuntary emotional outbursts in patients with neurological disorders.
In a late stage trial, Avanir was testing two doses of Zenvia against emotional outbursts in patients with multiple sclerosis and amyotrophic lateral sclerosis. The lower [...]
- MS Walking Improvement Drug Receives Negative FDA Review
By MATTHEW PERRONE (AP) – 2 days ago
WASHINGTON — Shares of Acorda Therapeutics plummeted Friday after the Food and Drug Administration issued a negative opinion that questioned the safety and effectiveness of the company’s multiple sclerosis drug.
A panel of FDA advisers is scheduled to meet next week to vote on Acorda’s Fampridine-SR, which is designed [...]
- 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 [...]
- RegeneRx’s Tβ4 Significantly Improves Functional Recovery in MS Animal Model
BETHESDA, Md.–REGENERX BIOPHARMACEUTICALS, INC. (NYSE Amex:RGN) announced today that researchers at the Henry Ford Health System in Detroit, Michigan, demonstrated for the first time that Tβ4 treatment of EAE (experimental autoimmune encephalomyelitis – an [...]
- Novartis says FTY720 reduces relapses
ZURICH, Sept 30 (Reuters) – Swiss drugmaker Novartis AG said on Wednesday its FTY720 oral drug to treat multiple sclerosis reduced both relapses and disability progression.
Initial results from the two-year Phase III study show that oral FTY720 was significantly superior to placebo in reducing both relapses and disability progression in patients with relapsing-remitting multiple sclerosis, [...]
- 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 study
Merck [...]
- Hot off the ECTRIMS Press…Alemtuzumab Shows Lasting Benefits in RRMS
(RTTNews) - Friday, biotechnology company Genzyme Corp. said that four-year follow-up data from its completed Phase [...]
