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Chelsea Therapeutics Resubmits New Drug Application for NORTHERA(TM) (droxidopa) for the Treatment of Symptomatic NOH

Posted: Published on July 9th, 2013

-- Submission Includes Successful 300 mg Bioequivalence Study -- Six Month Review Decision Expected Under PDUFA CHARLOTTE, N.C., July 9, 2013 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (CHTP) today announced that it resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval to market NORTHERA(TM) (droxidopa), an orally active synthetic precursor of norepinephrine, for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure (Parkinson's disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy. The NDA resubmission includes data from Study 306B, a large phase 3 study which confirms findings from Study 301 demonstrating improvement in dizziness/lightheadedness, the cardinal symptom of NOH. Under the Prescription Drug User Fee Act, or PDUFA, the FDA is expected to review and act on the NDA six months from the date of resubmission. "The resubmission of our Northera NDA marks a critical step in our effort to bring an important new therapeutic option to patients living with this debilitating condition," said Joseph G. Oliveto, Interim Chief Executive Officer of Chelsea. "We now have two large randomized placebo-controlled clinical studies which show that treatment with Northera results … Continue reading →

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Work at Medical College may hold promise for Parkinson’s

Posted: Published on July 9th, 2013

By Jon Byman CREATED 5:35 AM - UPDATED: 7:58 AM WAUWATOSA - Work being done at the Medical College of Wisconsin may hold promise for treatment of Parkinson's disease. "These are exciting times," said Dr. Balaraman Kalyanaraman, or Dr. Raman as he goes by. Dr. Raman is part of a group working on what could become a new treatment for Parkinson's. It's a long way off, but if they can demonstrate it works and fund drug trials, "that will change the way we treat this disease." Dr. Raman and his team have found an antioxidant that seems to slow the loss of motor function and smell when mice that were expected to get Parkinson's' symptoms were treated early. The team hopes to move to the next step and human trials, which they'd need to complete before the treatment could get to the market. Click Here to read more about the research. More: Work at Medical College may hold promise for Parkinson's … Continue reading →

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Acorda Therapeutics Announces Acquisition of Two Neuropathic Pain Assets

Posted: Published on July 9th, 2013

ARDSLEY, N.Y.--(BUSINESS WIRE)-- Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that it has acquired two neuropathic pain management assets from NeurogesX, Inc. (NGSX). Qutenza is approved by the U.S. Food and Drug Administration (FDA) for the management of neuropathic pain associated with postherpetic neuralgia. The Company also acquired NP-1998, a Phase 3 ready, prescription strength capsaicin topical solution, being assessed for the treatment of neuropathic pain. NP-1998 was previously referred to as NGX-1998. The acquisition of Qutenza and NP-1998 enables us to expand into the area of neuropathic pain management. We plan to support Qutenza with our existing medical and commercial infrastructure, which includes one of the industrys best neurology sales forces, said Ron Cohen, M.D., Acordas President and CEO. In addition, we will leverage our neurology expertise to evaluate NP-1998 for the treatment of neuropathic pain, with an initial emphasis on painful diabetic neuropathy. This adds another potentially important, late stage product to our pipeline. Acorda made an approximately $8 million payment to acquire development and commercialization rights for Qutenza and NP-1998 in the United States, Canada, Latin America and certain other territories, including $7 million paid to NeurogesX and approximately $900,000 for certain assumed accounts payable. Acorda will … Continue reading →

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These Earbuds Ping Your Head to Measure Swelling on Your Brain

Posted: Published on July 9th, 2013

If your brain is swelling, either due to infection or physical injury, you're going to need these Headsense cranial monitors more than you need another hole in your head. The fluids in your cranial cavity exerts a specific force on the brain and skull, known as your intracranial pressure (ICP), and help keep your brain from sloshing around in there. Sometimes, however, your ICP can rise due to a knock on the head or a disease like meningoencephalitis, causing the brain to squish against the skull and cut off blood flow to the afflicted regions (effectively causing you to stroke out). Even worse, the best treatment we have is to cut a hole in your skull and insert a catheter to monitor the problem. That sort of invasive intervention leads to all sorts of secondary infections, what with the big hunk of bone missing from the top of your head and all, and as such is only used as a last resort. Right now the main challenge with ICP is that the only good way to monitor it accurately and continuously is the invasive way, says Guy Weinberg, chief executive officer of HeadSense. Headsense is an Israeli startup that has … Continue reading →

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Injury Center Closed

Posted: Published on July 9th, 2013

JOHNSTOWN, CAMBRIA COUNTY--- The Department of Defense made the decision to close two of the network sites of the Defense and Veterans Brain Injury Center, one of which is in Johnstown. The decision was made in June 2013. On the center's website it was stated that it was not currently treating patients, no service members care was impacted. The center was started through earmarks from Congressman John Murtha. The neurorehabilitation site treated service members experiencing ongoing symptoms from a traumatic brain injury (TBI) and, simultaneously, another condition that might include behavioral health issues. In a statement online: "Because the facilities were unique and intensive, they handled a small number of patients and incurred high costs compared to other facilities. As the contract for the two sites expired and costs were measured, including those for a necessary information technology upgrade at each site, the DOD decided that other existing facilities could provide this care for service members." 30 people were laid off as a result of the center closing. Senator Bob Casey released a statement about the closing to WTAJ News. "The Defense and Veterans Brain Injury Center provided award-winning treatment for our military and veterans with brain injuries with professionalism … Continue reading →

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Research and Markets: FirstImpact: FDA approval of Aubagio

Posted: Published on July 9th, 2013

DUBLIN--(BUSINESS WIRE)-- Research and Markets (http://www.researchandmarkets.com/research/8q59sw/firstimpact_fda) has announced the addition of the "FirstImpact: FDA approval of Aubagio" report to their offering. The report presents the key insights gained from this major poll of neurologists. The research and analysis identifies the main clinical and commercial factors expected to influence the drug's positioning against current and upcoming rivals in the MS treatment algorithm and examines Aubagio's future prescribing trends. The report also draws upon recent news coverage, analysis, and other market research undertaken, to provide background information about Aubagio, its development and its potential commercial positioning. The addition of key analyst opinion and consensus product forecasts for oral MS therapies provide a commercial perspective set against the views expressed by physicians. The report and related data pack provides a comprehensive analysis of physicians' reactions for industry professionals who need to immediately understand the impact of breaking news. Reasons To Buy - Obtain insights into neurologists' positioning of Aubagio - Review the expected impact of Aubagio on physician prescribing - Understand neurologist perceptions of Aubagio versus other launched and pipeline oral therapies through poll results - Identify the most influential factors for Aubagio prescribing - Compare the efficacy and safety of Aubagio versus … Continue reading →

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Intimacy in an Iron Lung

Posted: Published on July 9th, 2013

The developing status of sexual surrogates for the disabled, as part of a right to health and well-being: So wrong? (The Sessions / Fox) "As my father lay dying and his private nurses washed him, made him comfortable and gave him his medication, they also lingered gently over his private parts as they sponged him. These were mountain girls from the state of North Carolina to whom death and sex were integral with life." So comments Google+ user Ray Chatham in the discussion surrounding a short documentary released last week fromThe New York Times' Stefania Rousselle. Rousselle investigated the state of sexual surrogacy for disabled people in France, where it is contentiously illegal. Surrogacy involves paying a professional who engages in intimate contact (broadly defined, though certainly not always intercourse) with a patient. It technically began in the early 1970s, and is maybe best known as something done to help people with extreme anxiety about sex to gradually work past it. In a different sense, it's also used for patients with serious physical disabilities -- and, maybe even thornier, mental disabilities like dementia. You might remember the 2012 filmThe Sessions, for which Helen Hunt got an Oscar nomination playing a … Continue reading →

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Zoghbi to receive Dickson prize in Medicine from University of Pittsburgh

Posted: Published on July 9th, 2013

Home Mail News Sports Finance Weather Games Groups Answers Flickr More omg! Shine Movies Music TV Health Shopping Travel Autos Homes Search News Search Web Sign In Mail Help Account Info Help Suggestions Yahoo! Home Video Photos GMA Year in Review LiveRoom Odd Comics Travel Opinion Trending Now Who Knew? Weather The Upbeat U.S. U.S. Video GMA Education Religion Crimes and Trials The Lookout Local Contributor Network Year In Review World World Video Middle East Europe Latin America Africa Asia Canada Australia/Antarctica Business Video Exclusives Today's Markets Stocks Personal Finance Marketplace Entertainment Video Clinton Concert Celebrity TV Movies Music Fashion Books Arts Theater Dear Abby Comics Odd News Sports Video NFL MLB NBA NCAAF NCAAB Soccer Cycling NHL Tennis Golf Boxing Motor Sports MMA Olympics Tech Gadgets Wireless Apple Social Media Security Open Source Gaming Apps This Could Be Big Upgrade Your Life Politics Remake America The Issues Women and Politics Press Releases Video Science Science Video Weather News Space / Astronomy Pets Dinosaurs / Fossils Biotech Energy Green Health Video Weight Loss Cancer Sexual Health Medications/Drugs Parenting/Kids Seniors/Aging Diseases/Conditions Blogs The Lookout The Sideshow Around the World Katie's Take Power Players This Could Be Big Newsmakers Trending Now Just … Continue reading →

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Menopause and Balance: HRT confusion has kept many hot and bothered

Posted: Published on July 9th, 2013

After a decade of rancorous debate over the risks and benefits of menopausal hormone therapy, experts from more than a dozen top medical organizations worldwide have finally come to something resembling a consensus. What did they decide, and why are women still baffled? What is menopausal hormone therapy? Also called hormone replacement therapy, its a treatment for women in the throes of menopause, the inevitable period of life when estrogen naturally declines. Taking estrogen or a combination of estrogen and another hormone, progestin, the synthetic form of progesterone, can alleviate some of the symptoms of menopause, including hot flashes, night sweats, insomnia and vaginal dryness, said Atlanta endocrinologist Scott Isaacs. Women typically hit menopause around age 51. Why is hormone therapy controversial? Hormone therapy has been under intense scrutiny since 2002, when a large study called the Womens Health Initiative reported that taking additional hormones - specifically the combination of estrogen and progestin - increased the risk of blood clots, stroke, breast cancer, heart attacks and gall bladder disease for some women. For a woman with a uterus, estrogen treatment alone raises her chance of getting endometrial cancer. The researchers abruptly halted the study, concluding that risks outweighed benefits. Almost … Continue reading →

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stem cell intro – Video

Posted: Published on July 9th, 2013

stem cell intro By: Jennifer Reynolds … Continue reading →

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