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Impax Wins FDA Nod For RYTARY ER Capsules For Treatment Of Parkinson''s Disease

Posted: Published on January 9th, 2015

By RTT News, January 08, 2015, 08:18:00 AM EDT (RTTNews.com) - Impax Pharmaceuticals, a division of Impax Laboratories, Inc. ( IPXL ), said the U.S. Food and Drug Administration approved RYTARY, an extended-release oral capsule formulation of carbidopa-levodopa, for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication and / or manganese intoxication. RYTARY is not for use in patients using nonselective monoamine oxidase inhibitors inhibitors. RYTARY contains immediate release and extended-release beads, with a specific amount of carbidopa and levodopa in a 1:4 ratio. It provides both initial and extended levodopa plasma concentrations after a single dose. RYTARY may be swallowed whole or, for patients who have trouble swallowing, the capsule may be opened and the beads sprinkled on applesauce and consumed immediately. Impax expects the four strengths of RYTARY, 23.75mg/95mg, 36.25mg/145mg, 48.75mg/195mg, and 61.25mg/245mg (carbidopa/levodopa) to be available for commercial distribution in February. The stock surged 12 percent in pre-market activity to $34.70. For comments and feedback: contact editorial@rttnews.com http://www.rttnews.com Continued here: Impax Wins FDA Nod For RYTARY ER Capsules For Treatment Of Parkinson''s Disease … Continue reading

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Risk of Brain Disorder Rare in Healthy Newborns with Jaundice

Posted: Published on January 9th, 2015

A study tracking more than 100,000 infants has shown that newborns with jaundice that are otherwise healthy are highly unlikely to develop a severe and potentially deadly form of cerebral palsy. Researchers at UCSF Benioff Childrens Hospital San Francisco and the Kaiser Permanente Northern California Division of Research sought to examine the correlation between elevated levels of the liver-produced pigment bilirubin, which causes the yellowing of the skin and eyes associated with jaundice, and cerebral palsy a range of disorders that impairs control of movement. The team was especially interested in kernicterus, a rare and life-threatening type of cerebral palsy triggered by escalating bilirubin that injures the brain. Jaundice occurs in most newborns because the immature liver is unable to break down the pigment fast enough. Treatment is not usually required, but in some cases babies undergo phototherapy, in which they are exposed to special lights that change bilirubin into a compound that can be excreted. In cases when very high bilirubin fails to drop, an infant may have an exchange transfusion, which is the replacement of blood with donor blood. The study, which evaluated the health records of two groups of babies selected from 525,409 births, was led by … Continue reading

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New recommendations for return to activity after concussion in military personnel

Posted: Published on January 9th, 2015

Expert guidance appears in annual military TBI issue of Journal of Head Trauma Rehabilitation January 8, 2015 - Military service members with mild traumatic brain injury (mTBI), or concussion, should follow a six-step process of progressive activity, leading to return to active duty, according to new clinical recommendations by an expert panel. The guidance appears in the January-February issue of The Journal of Head Trauma Rehabilitation, official journal of the Brain Injury Association of America, an annual special issue devoted to new research on TBI in the military. The journal is published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health. The new guidance includes specific recommendations for rest and activity, based on minimal or absent symptoms at each stage of the progression. The clinical recommendations were developed by a Progressive Activity Working Group established by the Defense and Veterans Brain Injury Center (DVBIC). Specific Guidance for Return to Activity after Military mTBI The Working Group consisted of Department of Defense representatives across all service branches and from the Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury, as well as other experts with experience assessing military patients with mTBI. The lead author was Karen L. … Continue reading

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Military gets new guidelines for post-concussion return to duty

Posted: Published on January 9th, 2015

WASHINGTON, Jan. 8 (UPI) -- The military is updating its protocol for treatment and return to active duty following concussions and traumatic brain injuries. The new guidelines dictate a six-step process of progressive activity, which must be completed before military personnel are allowed back on active duty. The new guidelines were compiled by the Progressive Activity Working Group, which was assembled by officials at the Defense and Veterans Brain Injury Center. The ad hoc group consisted of experts in neuroscience and brain injuries, as well as Department of Defense representatives from throughout the military. Research shedding new light on the compounding and long-lasting effects of concussions have moved leaders in a variety of fields and industries to rethink treatment and recovery guidelines for traumatic brain injuries. While this development has garnered the most attention within the context of sports, especially football, the military's decision to revamp TBI protocol was, in fact, an effort to personalize rest and recovery guidelines for soldiers and other military personnel -- to update research heavily reliant on sports-related studies. "Although service members share similarities with athletes," lead researcher Dr. Karen L. McCulloch, a neuroscientist at the University of North Carolina-Chapel Hill, wrote in an introduction … Continue reading

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Ministers wife walks again after treatment

Posted: Published on January 9th, 2015

After years in a wheelchair, a Tallowood Baptist Church woman can now walk again after receiving a drug that was already inside her body. In 2001, Debbie Bertrand was diagnosed with multiple sclerosis, a condition which eventually took the function of her hands and her ability to walk. After hearing about stem-cell therapy from a friend in church one day, she decided to give it a try. Bertrand got her treatment in 2011 through Celltex Therapeutics, a Houston-based company specializing in stem cell collection and banking. The process works by removing two teaspoons of a patients fat and extracting millions of the patients own stem cells. The cells are then processed and multiplied in a lab over 6 weeks and then infused intravenously. For Bertrand, the effects were almost immediate. Within the first few days she could stand and walk again after being confined to a wheelchair for years. I still dont feel confident enough to walk without [the walker], but that gave me so much more freedom, says Bertrand. She has also regained function in her hands, which she had previously been unable to straighten. The treatment has also all but cured her Reynauds disease, a condition that inhibits … Continue reading

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PA Woman Awarded $1.5 Million for GBS Flu Shot Injuries

Posted: Published on January 9th, 2015

While Vaccines serve as a crucial function to rooting out diseases in our society, they also carry a small risk of causing autoimmune diseases. The Vaccine Injury Compensation Program (VICP) helps compensate these victims. The VICP awarded $1.5 million in December 2014 to a Lebanon Pennsylvania woman who developed Guillain-Barr Syndrome from a flu shot. Guillain-Barr Syndrome (GBS) is a rare but possible side effect of any vaccine, including the flu vaccine. This rare condition causes the bodys immune system to attack the peripheral nervous system. GBS can start out as muscle weakness or a tingling sensation and lead to paralysis. Two weeks after receiving the flu vaccine, Wendy Lister went to Good Samaritan Hospital with complaints of burning, tingling and numbness in her upper and lower extremities. She was admitted and diagnosed with GBS and ataxia, a nervous system disorder affecting movement and balance control. Lister was hospitalized for six weeks and underwent physical and occupational therapy, but she has not fully recovered. Listers Guillain-Barr flu shot injuries left her with constant pain and numbness in her hands and feet. She is unable to walk more than a short distance or drive. Because of her recurring injuries, she has … Continue reading

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Is HRT or hormone replacement therapy beneficial? – Video

Posted: Published on January 9th, 2015

Is HRT or hormone replacement therapy beneficial? HRT or hormone replacement therapy can change your life! It isnt for everyone, but you I encourage you to see your doctor if you have menopausal symptoms, a... By: Lorraine C. Ladish … Continue reading

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Smoking, alcohol, gene variant interact to increase risk of chronic pancreatitis

Posted: Published on January 9th, 2015

PITTSBURGH, January 8, 2015 - Genetic mutations may link smoking and alcohol consumption to destruction of the pancreas observed in chronic pancreatitis, according to a 12-year study led by researchers at the University of Pittsburgh School of Medicine. The findings, published today in Nature Publishing Group's online, open-access journal Clinical and Translational Gastroenterology, provides insight into why some people develop this painful and debilitating inflammatory condition while most heavy smokers or drinkers do not appear to suffer any problems with it. The process appears to begin with acute pancreatitis, which is the sudden onset of inflammation causing nausea, vomiting and severe pain in the upper abdomen that may radiate to the back, and is typically triggered by excessive drinking or gallbladder problems, explained senior investigator David Whitcomb, M.D., Ph.D., chief of gastroenterology, hepatology and nutrition, Pitt School of Medicine. Up to a third of those patients will have recurrent episodes of acute pancreatitis, and up to a third of that group develops chronic disease, in which the organ becomes scarred from inflammation. "Smoking and drinking are known to be strong risk factors for chronic pancreatitis, but not everyone who smokes or drinks damages their pancreas," Dr. Whitcomb said. "Our new … Continue reading

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Study provides insights into the role of genetic variants in kidney disease

Posted: Published on January 9th, 2015

Highlights Washington, DC (January 8, 2015) -- New research provides insights into the ties between certain genetic variants and kidney disease in African Americans. The genetic association is one of the strongest ever reported for a common disease, and these latest findings may help improve diagnosis and treatment. The study appears in an upcoming issue of the Journal of the American Society of Nephrology (JASN). African Americans have a 4-fold increased risk for chronic kidney disease compared with European Americans. Recent work from several research groups has shown that much of this risk is due to genetic variations in a gene called apolipoprotein L1 (APOL1), which creates a protein that is a component of HDL, or good cholesterol. These variants arose tens of thousands of years ago in sub-Saharan Africa, and so are present in individuals who have recent sub-Saharan African ancestry. Approximately 5 million African Americans carry APOL1 risk variants, placing them at increased risk for kidney disease. Jeffrey Kopp, MD (National Institutes of Health) and his colleagues investigated the role of APOL1 variants in a particular form of kidney disease called focal segmental glomerulosclerosis (FSGS). The team studied information on 94 patients with FSGS and found that patients … Continue reading

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RetroSense Therapeutics Raises $6 million in Series A Financing to Further Develop Lead Product RST-001 for Retinitis …

Posted: Published on January 9th, 2015

ANN ARBOR, Mich.--(BUSINESS WIRE)--RetroSense Therapeutics (www.retro-sense.com), a privately-held biopharmaceutical company, today announced that it has secured $6 million in a Series A financing to further investigate the use of gene therapy and optogenetics to restore vision loss. The investment syndicate includes Nerveda, Blue Water Angels, SDL Ventures, Tech Coast Angels, and Michigan Economic Development Corporation. The proceeds should enable completion of preclinical studies needed to support an Investigational New Drug (IND) filing with the U.S. Food and Drug Administration for its lead compound, RST-001 for the treatment of Retinitis Pigmentosa, a cause of vision loss and blindness. We believe this financing round should provide us with sufficient capital resources to support our IND filing in early 2015 for our lead product, RST-001, said Sean Ainsworth, CEO of RetroSense Therapeutics. We are focused on developing novel treatment options for patients with severe vision loss due to retinitis pigmentosa and completion of our preclinical studies will be the next step towards filing an IND and initiating clinical trials. Optogenetics refers broadly to means of conferring light sensitivity to cells that were not previously, or natively light sensitive. By applying optogenetics to retinas in which rod and cone photoreceptors have degenerated, RetroSense is … Continue reading

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