Supernus Pharmaceuticals of Rockville received final approval from the U.S. Food and Drug Administration, effective Aug. 16, for Trokendi XR, a once-daily extended release formulation of topiramate for the treatment of epilepsy. The company expects to launch the product and for it to be available in pharmacies over the next few weeks. The company reported that revenue for the second quarter was $281,000, up from $91,000 a year earlier. Its net loss widened to $27.4 million from a loss of $10 million a year earlier. Selling, general and administrative expenses almost tripled to $12.2 million due to increased sales and marketing costs related to the commercial launch of Oxtellar XR and the planned launch of Trokendi XR. Rockville biotechnology company MacroGenics has met a milestone with its first patient dosed in a Phase 1 trial of a treatment for cancer tumors called MGA271, triggering a $10 million payment to the company from partner Les Laboratoires Servier. MacroGenics plans to enroll 45 patients within three cohort groups and expects to complete the Phase 1 trial in 2014. MGA271 has significant potential to treat a variety of solid tumors, said Scott Koenig, president and CEO of MacroGenics, in a statement. Famous Daves … Continue reading →

Would you be able to tell if you or someone you know were having a stroke? People who are able to recognize their stroke symptoms and receive treatment within 90 minutes of their onset may experience a greatly reduced risk for permanent disability, according to a new study from the journal Stroke. Strokes are the fourth leading cause of death in the United States and the number one cause of disability, according to the American Heart Association. When a person experiences a stroke, time is of the essence. The faster doctors are able to administer clot-busting drugs, the sooner blood flow to the brain can be restored, preventing permanent damage. In order to assess the best window of time for treatment, researchers from Helsinki University Central Hospital in Finland studied 6,800 stroke patients at 10 stroke centers in Europe over the course of 14 years. They discovered that people suffering from mild to moderate strokes were less likely to experience disabling side effects if they were treated with clot-busting drugs within 90 minutes of first experiencing symptoms. Dr. Larry B. Goldstein, professor of neurology and director at the Duke Comprehensive Stroke Center in North Carolina, noted that while the window … Continue reading →

By Shane Huntington Neurologist Dr David Szmulewicz describes the human balance system, and whats going on in our brains and ears when we experience vertigo. SHANE HUNTINGTON I'm Dr Shane Huntington. Thanks for joining us. Most of us at some stage in our lives attempted to achieve the difficult task of taking a doll or action figure and standing it upright. At first glance, it would seem that these simple miniatures of the human form should stand as easily as we do but sadly they too easily topple over. Of course the reason for this poor performance is because these replicas lack something that we possess, namely a sophisticated balance system. The human body and that of many other animals has evolved a system of balance that is more sophisticated than anything we are yet able to model or reconstruct in the lab. Our balance system enables us to manage extraordinary acrobatic acts and, on a simpler scale, safely perform the necessary movements of day to day life. But what happens when this system fails? How do we react to a lack of balance and what can we do to resolve problems of this type? To discuss the balance system … Continue reading →