Biogen Idec and Knopp Neurosciences announced they have entered into an exclusive, worldwide license agreement under which Biogen Idec will develop and commercialize KNS-760704 for the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease. KNS-760704 is a novel oral neuroprotective therapy under development. In a Phase 2 study of ALS patients, the compound achieved its primary endpoint evaluating safety and showed favorable dose-related effects in preserving motor function.

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H. Lundbeck A/S (Lundbeck) and Teva Pharmaceutical Industries Ltd. announced newly published long-term data on Azilect® (rasagiline tablets) from the TEMPO study and its open-label extension. The findings confirm the long-term efficacy, safety and tolerability of Azilect® in patients with Parkinson’s disease (PD) and further demonstrate the benefits obtained with early treatment initiation. The data was published in the June 2010 issue of the International Journal of Neuroscience.

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FDA has lifted a clinical hold on Geron’s Investigational New Drug (IND) application – the Phase I clinical trial of GRNOPC1 in patients with acute spinal cord injury may now go ahead. GRNOPC1 is the first clinical trial of a human embryonic stem cell based therapy. The Phase I trials aims to establish the safety of GRNOPC1 in patients with “complete” American Spinal Injury Association (ASIA) Impairment Scale grade A subacute thoracic spinal cord injuries.

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Edge Therapeutics, Inc. has announced that it has entered into a feasibility agreement with SurModics, Inc. According to the agreement, SurModics will develop a novel biodegradable, site-specific, sustained-release formulation (NimoGel™, EG-1961) for treatment of delayed complications of ruptured brain aneurysms or traumatic brain injury (TBI). NimoGel, Edge’s lead drug, is a combination of the FDA-approved drug nimodipine, a calcium channel blocker, and a proprietary biodegradable delivery system.

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ArmaGen Technologies has developed the BBB molecular Trojan horse platform technology for solving the BBB drug delivery problem, and has used this technology to create a brain penetrating form of human EPO. ArmaGen® has successfully re-engineered human EPO as an IgG fusion protein that penetrates the brain following intravenous (IV) administration. Human EPO is fused to a genetically engineered monoclonal antibody (MAb) to the human insulin receptor (HIR).

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The research team, led by Dr. Richard Ambron, Professor of Pathology & Cell Biology at Columbia University Medical Center, has started developing N60 after his colleague, Dr. Ying-Ju Sung, Assistant Professor of Clinical Pathology, discovered the pathway that neurons use to inform the brain of an injury. Left uncontrolled, this pathway, called PKG, persistently alters the electrical properties of the neuron, ultimately causing chronic pain. Laboratory tests have shown that N60 is a powerful and very selective PKG blocker.

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The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has recommended approval for the novel oral agent fingolimod in the treatment of patients with relapsing-remitting multiple sclerosis (MS). The highly anticipated drug, Gilena, is the first in a new class of disease-modifying agents called sphingosine 1 phosphate receptor modulators. The drug reduces the frequency of clinical exacerbations and delays the accumulation of physical disability.

CytRx Corporation has announced that its drug candidate bafetinib (formerly known as INNO-406) demonstrated statistically significant inhibition of glioblastoma multiforme cell lines in a preclinical trial. Glioblastoma multiforme is the most common and aggressive primary adult brain tumor. Data from the trial, titled “Preclinical evaluation of Lyn kinase inhibition for treatment of glioblastoma multiforme,” will be presented in a poster at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO).

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XenoPort Inc. and GlaxoSmithKline PLC have said that the FDA needs three more months to review an application to a neuropathic pain drug being developed by them. The FDA should complete its review of the drug, called gabapentin enacarbil, by Feb. 9, 2010 said the companies. The FDA wanted the companies to develop a strategy to evaluate the drug’s risks, and after GlaxoSmithKline submitted that strategy, the agency needed additional time to review it.

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An FDA panel voted 12 to 1 that Acoherapeutics Inc’s Phase III trials provided substantial evidence that fampridine sustained-release was effective in improving the walking ability in patients with multiple sclerosis. The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee also voted 10 to 2, that there are conditions under which fampridine SR could be safely used as a therapy to improve walking in patients with MS.