By Chris Reidy, Globe Staff Marlborough drug maker Sunovion Pharmaceuticals Inc. said that US regulators have agreed to review its application to market a potential new treatment for the most common form of epilepsy. The drug candidate is called Stedesa, the proposed trade name for eslicarbazepine acetate, and if approved, it could offer US adults with epilepsy a way to manage partial onset seizures, Sunovion senior vice president Fred Grossman said in a statement included in the companys press release. The company first submitted an application for eslicarbazepine acetate to the US Food and Drug Administration in 2009. The company was still known as Sepracor Inc. then. That same year Sepracor was acquired by the Japanese drug maker Dainippon Sumitomo Pharma Co. Ltd., or DSP, for $2.6 billion. In 2010, DSP changed Sepracors name to Sunovion. In 2010, the FDA asked the company to provide it with additional information about eslicarbazepine acetate, and Sunovion said in a Wednesday press release that it has been informed by the FDA that the agency has sufficient data to review Sunovions drug application. Sunovion said it expects the FDA to make a decision about Stedesa/eslicarbazepine acetate later this year. Eslicarbazepine acetate won approval from … Continue reading →

Published: Feb. 28, 2013 at 12:25 PM PHOENIX, Feb. 28 (UPI) -- Children with autism had higher levels of several heavy metals in their blood and urine compared to typical children, U.S. researchers reported. Study leader James Adams, who directs the Arizona State University Autism/Asperger's Research Program, said the study involved 55 children with autism ages 5-16 compared to 44 controls of similar age and gender. The study, published in the journal Biological Trace Element Research, found the autism group had significantly higher levels -- 41 percent -- of lead in their red blood cells and 74 percent higher urinary levels of lead, 77 percent higher levels of thallium, 115 percent higher levels of tin and 44 percent higher levels of tungsten. Lead, thallium, tin and tungsten are toxic metals that can impair brain development and function, and also interfere with the normal functioning of other body organs and systems, Adams said. A statistical analysis was conducted to determine if the levels of toxic metals were associated with autism severity, using three different scales of autism severity. The study found 38 percent to 47 percent of the variation of autism severity was associated with the level of several toxic metals, … Continue reading →

SACRAMENTO, Calif. (AP) - California's insurance regulator has been getting complaints and wants last year's autism treatment law enforced. There's been an explosion in autism and demand for behavioral therapies. The California Department of Insurance says insurers have been skirting their obligation under the state law requiring insurers to provide costly behavioral therapies for autism. The treatments can cost $50,000 a year for each child. The Los Angeles Times (http://lat.ms/XDRGFw ) says the agency is now proposing emergency regulations aimed at getting insurers to cover the treatments. The Office of Administrative Law will decide in March whether to put them into effect. State officials say they have received dozens of complaints that insurers have been delaying and denying coverage by imposing limits on how much therapy a child can receive and who can provide it. Information from: Los Angeles Times, http://www.latimes.com Copyright 2013 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed. See the rest here: Insurance commissioner wants autism law enforced … Continue reading →

A bill to mandate insurance coverage for autism treatment received a drastic makeover Thursday in the Utah Senate, disappointing hundreds of parents who hoped they could soon afford the necessary therapies for their children. In its original form, SB55 would have required insurance coverage for children diagnosed with autism spectrum disorder. About 18,000 such youth live in Utah, said the bills sponsor, Sen. Brian Shiozawa, R-Cottonwood Heights. Realizing the measure lacked the votes to pass either legislative chamber, Shiozawa pared it back Thursday, nixing the insurance and confining it to expansion of a pilot program enacted last year. He is asking to double participants to 500 and raise the age limit to seven. The current pilot program tops out at age six. "Its not my first choice," Shiozawa said of the substitute bill. "After conferring with House and Senate leadership I dont have the support of the insurance industry, and I frankly dont have the votes for the bill in its original form." The latest version of SB55 seeks $1.5 million in one-time funding to expand the pilot program, which Shiozawa believes would yield more accurate statistical data as a result. The original SB55 had estimated state budget costs at … Continue reading →

Feb. 28, 2013 Blockages in your heart arteries could mean you're more likely to have a stroke, even if you're considered low risk, according to research in the American Heart Association journal Stroke. "This study demonstrates that stroke risk is tightly aligned with coronary atherosclerosis, showing the closely related nature of cardiovascular and cerebrovascular disease," said Dirk M. Hermann, M.D., the study's lead investigator and professor of vascular neurology and dementia at the University Hospital Essen in Germany. "This raises the need for intensified interdisciplinary efforts for providing adequate disease prevention and management strategies." In the study, researchers used the non-invasive electron beam-computed tomography, a variation of the conventional CT scan, to determine how much plaque had built up in the coronary arteries of 4,180 patients who had no previous strokes or heart attacks. The patients, men and women 45-75 years old, were followed for about eight years. During the study, 92 strokes occurred. The blockages, caused by coronary artery calcification (CAC), were significantly higher in those who had a stroke than those who didn't. Those who had CAC levels of more than 400 Hounsfield units (HU), a density measurement, were three times more likely to have a stroke than … Continue reading →

Feb. 28, 2013 From the moment a person starts to experience stroke symptoms, the clock starts ticking. Every minute that passes can make a difference in how well their brain, arms, legs, speech or thinking ability recover. Now, new national guidelines for stroke treatment -- co-authored by a member of the University of Michigan Comprehensive Stroke Program -- make it clear just how much minutes count. They also lay out a role for all types of hospitals in treating stroke emergencies, including community hospitals of the type involved in a recent U-M led study of stroke care. The American Stroke Association guidelines are published in the American Heart Association journal Stroke. The authors include Phillip Scott, M.D., a U-M emergency physician and member of the U-M Comprehensive Stroke Program. Here are some key numbers: Air medical transport and telemedicine support from large stroke-center hospitals such as U-M should be used to supplement the care any particular hospital can provide, the guidelines say. The new guidelines recommend integrating regional networks of comprehensive stroke centers (which offer 24/7, highly specialized treatment for all types of stroke); primary stroke centers (which provide 24/7 specialized care mainly for ischemic stroke); and acute stroke-ready hospitals … Continue reading →