Monthly Archives: July 2012

ROCKVILLE, Md., July 13, 2012 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (SUPN), a specialty pharmaceuticals company, announced on June 26 that it received a tentative approval letter from the Food & Drug Administration (the "FDA") for Trokendi XR(TM), a once-daily extended release formulation of topiramate (formerly known as SPN-538). The letter states that the FDA completed its review of the Trokendi XR NDA and that no additional clinical trials are required. The letter also states that final approval may not be made effective by the FDA until the period of exclusivity protection associated with safety information regarding a specific pediatric population expires. Since then, the Company has been in discussion with the FDA to clarify which of the three marketing exclusivities (December 2012, June 2013 or July 2014) that are listed in the Orange Book the FDA is referring to and how such exclusivity applies to its NDA. The Company is pleased to provide the following update. The marketing exclusivity that the FDA is referring to relates to pediatric patients, age 1-24 months. This exclusivity expires on June 22, 2013. Although such age bracket is not part of the patient population for which Trokendi XR will be indicated, the FDA … Continue reading →

DALLAS, July 13, 2012 (GLOBE NEWSWIRE) -- Finding the right hospital for treating heart disease and stroke just got easier, thanks to a new online tool from the American Heart Association/American Stroke Association. The interactive map lets you search by city or zip code for hospitals recognized by the organization's quality achievement awards program. Hospitals receiving these awards are among the best in the nation in following treatment guidelines proven to increase survival rates and reduce readmission rates for heart attack, heart failure and stroke patients. The hospital map is just one tool found on a new website (www.heart.org/myhealthcare) with information and resources to help heart disease and stroke patients and their families learn more about living with these conditions. "This website has a tremendous collection of resources for you to learn more about living with cardiovascular disease and stroke. The map is especially helpful in finding high quality medical care in your area. Equipped with these tools, you can make more informed decisions about your healthcare -- before you need it," said Gregg C. Fonarow, M.D, chairman of American Heart Association Hospital Accreditation Science Committee and professor of cardiovascular medicine of the University of California, Los Angeles. "But it's … Continue reading →

July 13, 2012 Connie K. Ho for redOrbit.com Your Universe Online Scientists from the Washington University School of Medicine recently revealed that they have developed a timeline that shows early signs of Alzheimers, even with unseen progress. The team of researchers examined families who had a genetic risk of having the disease. The findings, which were published recently in the New England Journal of Medicine, show that signs of Alzheimers can appear up to 25 years before diagnosis of the disorder. This important research highlights that key changes in the brain, linked to the inherited form of Alzheimers disease, happen decades before symptoms show, which may have major implications for diagnosis and treatment in the future, commented Clive Ballard, director of research at the Alzheimers Society, in a article by the BBC. The study included 128 people from Australia, the United Kingdom, and the United States. Of all the participants, 50 percent had the possibility of inheriting one of three mutations that could lead to Alzheimers. These mutations were found in people who were in their 30s and 40s, and those who had the mutations would later develop Alzheimers. Researchers state that the findings are useful in understanding the patterns … Continue reading →