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 [...]
- Newly Published Data Show Copaxone Promoted Remyelination of Damaged Axons
The purpose of this study was to examine the effect of glatiramer acetate on oligodendrogenesis (the formation of myelin-producing glial cells in the central nervous system) and myelin formation in damaged nerve cells in mice
The mice were subjected to lysolecithin-induced demyelination of the spinal cord, then treated daily for seven days with a 2mg injection [...]
- Teva Sues Mylan Over MS Drug Copaxone
Teva Pharmaceutical Industries Ltd. issued a press release last week discussing the abbreviated new drug application (ANDA) containing a Paragraph IV certification for COPAXONE® (glatiramer acetate injection), filed by Mylan Pharmaceuticals Inc. Teva announced that it has filed a lawsuit against Mylan Pharmaceuticals, Inc., Mylan Inc. and Natco Pharma Ltd. for patent infringement in the [...]
- A New Cause for MS?
By Henry L. Davis
NEWS MEDICAL REPORTER
October 15, 2009, 6:36 AM
Buffalo physicians announced Wednesday that they have started a large study that could overturn thinking about the generally accepted cause for multiple sclerosis.
MS is believed to stem from an abnormal response of the body’s immune system directed against the fatty sheath that surrounds nerve [...]
- What’s the Point of Extavia?
Featured Story Oct. 16, 2009
By Angela Maas, Managing Editor
Another drug in the self-injected multiple sclerosis (MS) class recently came onto the marketplace. But many within the pharmaceutical industry are saying that other than giving Novartis an entry into the MS market before its [...]
- 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 [...]
- Copaxone Used for First-Episode/CIS Halves MS Risk
PARIS — Early treatment with a key drug to fight multiple sclerosis (MS) nearly halves the risk of progression to the full-blown disease, according to a study published online on Wednesday by The Lancet.
The treatment, glatiramer acetate, marketed as Copaxone, was tested in 16 countries among 481 patients with a telltale lesion in the central [...]
