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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Integra LifeSciences Holdings Corporation has announced the launch of the CUSA ShearTip(TM) for its CUSA EXcel(R) Ultrasonic Surgical Tissue Ablation platform that includes the CUSA EXcel(R) and the CUSA EXcel(R)+ systems. The CUSA ShearTip(TM) has received 510(k) clearance from the United States Food and Drug Administration (FDA) and CE Mark Certification in the European Union. The new tip design will expand the use of the CUSA EXcel(R) platform in neurosurgical applications and beyond.

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.

Neuralstem Inc has received approval from the US health regulators to start an early-stage human trial of its spinal cord stem cells in Lou Gehrig’s disease, a fatal neuromuscular condition. The trial, which will test the safety of the cells and the surgery procedure, will ultimately consist of 18 patients suffering from the disease, also known as amyotrophic lateral sclerosis (ALS), the company said.

Covidien plc received the FDA approval for the use of its tissue sealant product DuraSeal for use during spine surgery. Covidien expects to start selling DuraSeal for spinal use within a few weeks. The product has been on the market since 2005 for use during brain surgery. “DuraSeal continues Covidien’s dedication to scientific, evidence-based innovation that improves patient outcomes,” Dr. Michael Tarnoff, chief medical affairs officer for Covidien’s surgical devices unit, said in a statement.

The FDA has approved BrainScope ZOOM-100DC, a handheld device for people with possible traumatic brain injury. The ZOOM-100DC is intended to monitor the state of the brain by acquisition and display of electroencephalogram (EEG) signals. The 8-channel product, capable of recording and displaying EEG waveforms and providing conventional EEG measures displayed in tables, is designed especially for those patients who don’t have immediate access to a hospital.

Genentech, Inc. has submitted an application to the U.S. Food and Drug Administration  for its product Avastin® as a therapy for patients of glioblastoma who have received a treatment previously. If the supplemental Biologics License Application (sBLA) is accepted by the FDA, the drug can be considered for a provisional approval for treatment of cancer and other such deadly diseases. Glioblastoma is the most aggressive form of brain cancer. It has no cure. The study found that Avastin, when as evaluated as a single agent, showed that 43 percent of patients experienced no progression of disease.

The U.S. Food and Drug Administration has given the approval to UCB’s Vimpat® (lacosamide) for use as an adjunct therapy in the treatment of partial-onset seizures in epilepsy patients older than 17 years of age. The novel anti-epileptic drug has an innovative mechanism of action which involves the modulation of activity of sodium channels in the nervous system. It prolongs the long-lasting resting condition of the channel, thereby controlling the hyperactive nerve cells.

The U.S. Food and Drug Administration has cleared US Spine’s Preference 2 Complex Spine System™ for use in the United States. With this approval, US Spine makes an entry into the deformity and trauma market. Designed by some of the leading spine surgeons for the treatment of complex spinal conditions, the system is featured by a number of new components that include hooks, screws and rods. The anchoring implants in the system are featured by Helical Flange® Closure mechanism that reduces cross threading drastically and eliminates head splay.

The U.S. Food and Drug Administration has approved AstraZeneca’s once-daily Extended-Release Tablets, SEROQUEL XR (quetiapine fumarate) for the acute treatment of episodes of depression and mania related to bipolar disorder. In the long term, patients suffering from this disease may experience depressive symptoms as long as three times to that of manic symptoms. It must be noted that this is the first such medication approved buy the regulatory authority for treating the serious psychiatric illness.