Acceptance of the NDA indicates that the FDA has found the company's resubmission to be sufficiently complete to review. Eisai originally submitted the perampanel NDA to the FDA in May 2011, however, resubmitted it in December 2011 after reformatting and reanalyzing some datasets in the dossier as requested by the FDA in a Refuse to File letter issued in July 2011. Perampanel is a novel chemical entity discovered and being developed by Eisai. If approved, the agent will be the first in a new class of highly selective, non-competitive AMPA-type glutamate receptor antagonists. Eisai defines epilepsy as a therapeutic area of focus, and seeks to make further contributions to address the diversified needs of, and increase the benefits provided to, epilepsy patients and their families by offering them multiple treatment options. About Eisai Eisai Co., Ltd. (TSE: 4523; ADR: ESALY) is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: integrative neuroscience, including neurology and psychiatric medicines; integrative oncology, which encompasses oncotherapy and supportive-care treatments; and vascular/immunological reaction. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all … Continue reading →

Newswise CHARLOTTESVILLE, Va., March 5, 2012 For about 25 percent of patients suffering from epilepsy, medications do not effectively control the disease and stop seizures. For some, epilepsy surgery is the best answer. In the past, epilepsy surgery meant a craniotomy, which requires a surgeon to open the patients skull to remove the brain lesion causing epilepsy. To determine whether a noninvasive surgery could effectively treat patients with a certain type of epilepsy mesial temporal lobe epilepsy University of Virginia School of Medicine neurologist Mark S. Quigg, MD, is helping lead an international clinical trial examining the effectiveness of Gamma Knife radiosurgery. The Gamma Knife delivers focused beams of radiation guided by MRI to the brain lesion in hopes of damaging the lesion and preventing it from causing epileptic seizures. This trial could offer patients with the appropriate kind of epilepsy a choice of noninvasive surgery, says Quigg, the trials co-principal investigator. Epilepsy surgery probably is underutilized, and an alternate method may bring the benefits of surgery to a wider group of patients. Gamma Knife vs. craniotomy Supported by a grant of up to $20 million from the National Institutes of Health, the clinical trial will randomly assign 217 volunteer … Continue reading →

Eric Courchesne managed to find a positive thing about getting polio: It gave him a clear idea of what he would do when he grew up. Courchesne was stricken in 1953, when he was 4. The infection left his legs so wasted that he couldnt stand or walk. My mother had to carry me everywhere, he says. His parents helped him learn how to move his toes again. They took him to a pool to learn to swim. When he was 6, they took him to a doctor who gave him metal braces, and then they helped him learn to hobble around on them. Doctors performed half a dozen surgeries on his legs, grafting muscles to give him more strength. Courchesne was 11 when the braces finally came off, and his parents patiently helped him practice walking on his own. Through their encouragement, I went on to have dreams beyond what youd expect, he says. He went to college at the University of California, Berkeley. One day he stopped to watch the gymnastics team practicing, and the coach asked him to try out. Before long Courchesne was on the team, where he won the western U.S. championship in still rings. … Continue reading →

The Michigan Supreme Court on Thursday expects to hear arguments relating to union activist Robert Davis' suit against Detroit Public Schools emergency manager Roy Roberts. Davis, who also sits on Highland Park's school board, filed suit against Roberts claiming that his oversight of DPS is invalid due to him belatedly taking an oath of office. The case will be heard in Lansing on Thursday. On Tuesday, the Senates Health Policy Committee could vote on a bipartisan package to mandate autism diagnosis and treatment be covered by health insurance. Virtual voting ban clears House, heads to state Senate. Tuesday, Feb. 28 What happened: Elected leaders would need to physically attend a meeting in order for their vote to be counted according to a bill that was approved in the state House. Rep. Richard LeBlanc, D-Westland, said his bill prohibits leaders from voting through a telephone conference call or online video conferencing program like Skype. Theyd still be allowed to participate in discussions, but they could not vote and they could not be counted toward a quorum. Why it matters: LeBlanc said elected leaders should have to look residents in the eye when they take tough votes, and not vote through a … Continue reading →

NEW YORK, March 5, 2012 /PRNewswire/ --Different Roads to Learning, Inc., a global retailer of educational products for children diagnosed with Autism Spectrum Disorder and other developmental disabilities, today announced the launch of Tell Me About It! Learning Language by Receptive Function, Feature & Category, an iPhone/iPad app for developing early language skills. This app uses Applied Behavior Analysis (ABA), a systematic teaching approach that involves breaking down skills into small, easy-to-learn steps. ABA is the only evidence-based effective intervention treatment for Autism endorsed by the American Academy of Pediatrics and the United States Surgeon General.The Tell Me About It! App is now available for $9.99 atiTunes. "A new wave of educational apps has been on the rise since the iPad first launched; now, they are more efficient and visually stimulating than ever. These apps are especially pertinent in the early education of children with Autism Spectrum Disorders. We are pleased to develop theTell Me About It! App, which covers the basic foundations of language for children diagnosed with Autism. Our Tell Me About It! App for the iPhone and iPad allows parents and professionals to apply ABA in any setting," said Julie Azuma, CEO of Different Roads to Learning, … Continue reading →

Public release date: 5-Mar-2012 [ | E-mail | Share ] Contact: Dr. Kathrin Bilgeri kathrin.bilgeri@lmu.de 49-892-180-6938 Ludwig-Maximilians-Universitt Mnchen LMU researchers developed a new strategy for the treatment of stroke, which could help to improve blood flow to ischemic brain. Strokes are due to a localized reduction in the blood supply to the brain, mainly due to the blockage of a vessel by a blood clot. This can lead to the death and irreversible loss of nerve cells. In about 90% of cases, no dedicated treatment is available that can effectively prevent serious damage following an acute stroke. A team led by LMU researcher Professor Nikolaus Plesnila has now shown, in an animal model, that inhalation of nitric oxide (NO), a chemical compound which is itself toxic, can improve perfusion of the brain in the aftermath of an acute stroke. Brain function in treated animals was significantly improved as compared to in controls that had not been given NO. "In collaboration with colleagues at Harvard Medical School, we have just begun to test whether or not NO has a comparable effect in humans. If so, we could then initiate a full-scale international clinical study," says Plesnila. "If such a trial were … Continue reading →

National screening programmes for over-65s should be "urgently" introduced to reduce the number of premature deaths caused by stroke, medical experts have said. The call to the UK and Scottish governments was made after a meeting of more than 120 stroke specialists from around the country. The meeting, convened by the Royal College of Physicians of Edinburgh (RCPE), was held to find methods of improving diagnosis and treatment for atrial fibrillation (AF), a heart condition which significantly increases the risk of stroke. It is the most common, sustained heart disorder and the risk factors increase with age. Experts said blood-thinning drugs can be used to treat the condition but it is often under-treated as it does not always display symptoms. The two-day meeting held last week allowed them to review the current evidence and produce clinical guidance for the NHS. Recommendations reached include the need for a national screening programme. Experts said the most cost-effective way of doing so would be to target all over-65s by checking pulses in GP surgeries. Further tests would then be arranged for those with irregular pulses. Dr Scott Ramsay, consultant in stroke medicine, said: "The goal of treating atrial fibrillation is primarily to reduce … Continue reading →