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Jakafi® (ruxolitinib) Prescribing Information Updated with Expanded Dosing Guidance and New Safety Information

Posted: Published on June 12th, 2013

WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte Corporation (INCY) announced today that the U.S. Food and Drug Administration (FDA) has updated prescribing information for Jakafi (ruxolitinib) to include new recommended dosing guidance for patients with low platelet counts and additional safety information. Approved in November 2011, Jakafi is the first and only FDA-approved product for the treatment of patients with intermediate or high-risk myelofibrosis. The prescribing information for Jakafi now includes a new recommended starting dose of 5 mg twice daily of Jakafi for patients with baseline platelet counts between 50100 x 109/L (50,000 to 100,000) and the flexibility for subsequent dose modifications based on safety and efficacy. The FDA decision to expand the dosing information followed a review of the supplemental New Drug Application (sNDA), which included data from an ongoing Phase II trial (Study 258) of patients with baseline platelet counts of 50,000 to 100,000. In this trial, the starting dose of 5 mg twice daily could be adjusted up or down based on protocol defined hematology criteria with a target dose of 10 mg twice daily to achieve clinical response. The safety and efficacy findings from the current interim analysis of Study 258 are generally consistent with the results observed … Continue reading

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BioTime Appoints Henry L. Nordhoff to Board of Directors

Posted: Published on June 12th, 2013

ALAMEDA, Calif.--(BUSINESS WIRE)-- BioTime, Inc. (NYSE MKT:BTX) today announced that Henry L. Nordhoff, former CEO and Chairman of Gen-Probe Inc., has been appointed to its Board of Directors. We are pleased to welcome an accomplished healthcare executive of Hank's caliber to BioTime's board, said Alfred D. Kingsley, Chairman of the Board of BioTime. Hank's 43 years of experience in the pharmaceutical business, including most recently his leadership role in managing impressive growth at Gen-Probe over a 15-year period should prove valuable as BioTime continues to pursue multiple growth opportunities. BioTime is a leading company in the emerging field of Regenerative Medicine, said Mr. Nordhoff. I am pleased to be joining BioTime at this important juncture, as the company moves towards translating a magnificent array of technologies into products, and then introducing those products into the marketplace to alleviate suffering and cure diseases. Mr. Nordhoff is the former CEO and Chairman of Gen-Probe, Inc., a leading molecular diagnostics company which was acquired in 2012 in an all-cash transaction that valued the company at $3.72 billion. Under Mr. Nordhoff's leadership, Gen-Probe introduced numerous innovative diagnostic products to test for a host of infectious disease-causing viruses and bacteria, screening products to help identify … Continue reading

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Scotland Continues to Forge Ahead in Stem Cell Research

Posted: Published on June 12th, 2013

BOSTON, June 12, 2013 /PRNewswire/ --Scotland's standing as Europe's largest and most highly regarded stem cell research community has been reaffirmed recently by announcements of funding from the UK Medical Research Council (MRC) and the British Heart Foundation to the MRC Centre for Regenerative Medicine (CRM) based at the Edinburgh BioQuarter. As part of a major $25m boost for UK regenerative medicine, the Edinburgh center will play a key role in the development of new therapies. This and other recent news exemplify Scotland's strength and depth of expertise in this field. Developments at an academic level describing increased understanding of the mechanism of cellular reprogramming were recently reported by Dr. Keisuke Kaje from the MRC-CRM in Nature, whilst Scottish company Roslin Cells and the MRC-CRM have been actively collaborating on iPS cell line production ensuring a more quality-oriented perspective and generating more commercial opportunities. Elsewhere, exciting research at Heriot-Watt University has seen the use of 3D printing techniques to produce clusters of viable stem cells that could speed up progress towards creating artificial organs. In the immediate future, Professor Will Shu and his team hope the technique can be used to generate biopsy-like tissue samples for drug testing. At a … Continue reading

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The Science of Mesenchymal Stem Cells and Regenerative Medicine – Arnold Caplan PhD (Part 2) – Video

Posted: Published on June 12th, 2013

The Science of Mesenchymal Stem Cells and Regenerative Medicine - Arnold Caplan PhD (Part 2) In part 2, Prof. Caplan discusses the two types of regenerative medicine: tissue engineering and in vivo tissue regeneration, hematapoietic and mesenchymal s... By: http://www.cellmedicine.comContinue reading

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Are Root Canals Headed for Obscurity? Stem Cell Study Indicates Maybe So

Posted: Published on June 12th, 2013

Durham, NC (PRWEB) June 12, 2013 Scientists report in the current issue of STEM CELLS Translational Medicine that they are close to developing a new and effective way to treat tooth decay that fully restores the tooth rather than requires it to be filled, capped or extracted. The method, which uses stem cells, could prove especially useful in treating the kinds of cavities leading to that most dreaded and painful procedure the root canal. Dental cavities and inflammation of the surrounding pulp is a challenging public health issue, as tooth decay not only can cause a patient great pain but it also can lead to other serious health issues including heart disease, explained Misako Nakashima, DDS, Ph.D., of the National Center for Geriatrics and Gerontology in Obu, Japan. Generally we treat deep cavities by capping the tooth and removing any inflamed pulp surrounding it. But this has limited success and the problem frequently progresses until the tooth must be removed. In this newest study, conducted by Dr. Nakashima and several of her NCGG colleagues along with scientists from Shin Nippon Biomedical Laboratories in Kagoshima and from the School of Dentistry at Aichi-gakuin University in Nagoya, the goal was to test … Continue reading

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Back on Web.com Tour, Klauk ready to play at one of favorite stops

Posted: Published on June 12th, 2013

In a perfect comeback tale, Jeff Klauk wouldnt be at Crestview Country Club this week preparing to play in his ninth Air Capital Classic. Klauk would be in Pennsylvania teeing it up at the U.S. Open. Or hed be home in Florida, getting some rest and relaxation for next weeks PGA Tour event. But the 35-year-old Klauks golf career has been all about patience. And as the 2003 Air Capital Classic champion continues his return from time off for epilepsy treatment, the site of his first Web.com Tour victory isnt a bad place to be. I missed playing everywhere last year, but Wichita holds a special place, Klauk said. With what people did for me here last year, its amazing all the support I have. During last years tournament, Klauk was two months removed from brain surgery that determined the location of his neurological disorder, which first surfaced in 2006. He was scheduled to have a second procedure last August to remove damaged tissue, but chose to forego it and treat his condition with medication. While Klauk was home recuperating, his host family during his tournament stays in Wichita took action. Rick and Vicky Heibsch organized an Epilepsy Awareness Day … Continue reading

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Join Flightlinez and Nevada Epilepsy June 12th – Flights for a Fight

Posted: Published on June 12th, 2013

Las Vegas, NV (PRWEB) June 11, 2013 Flightlinez and the Fremont Street Experience invite supporters to zipline down Fremont Street and assist in raising funds in an effort to support Nevada Epilepsy. Volunteers from Nevada Epilepsy will be on site to provide more information about the organization, their upcoming activities and events and they will be selling cookies. Entertainment will be hosted by local dance, drill, drum and singing groups from around the area will be right in front of the Flightlinez Office near the take off tower. Who: Flightlinez Las Vegas zipline attraction, Fremont Street Experience, Nevada Epilepsy What: Flightlinez and the Fremont Street Experience will donate all net proceeds from zipline rides on Wednesday June 12, 2013 from noon to midnight to Nevada Epilepsy. Nevada Epilepsy Since 2004, Nevada Epilepsy has been dedicated to the welfare of people with epilepsy. With the continued support of Sunrise Hospital and Nevada Neurosciences Institute, they are able to meet our goals. The goals are to prevent and cure seizure disorders, promote public awareness, and the promotion of independence and optimal quality of life for people who have these disorders. Flightlinez is committed to serving the Las Vegas community by hosting charitable … Continue reading

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Epilepsy drug helps locate dirty drinking water, Israeli researchers learn

Posted: Published on June 12th, 2013

Carbamazepine, a drug used to treat epilepsy, could become an important tool in finding pollutants in sources of drinking water, according to a study conducted by Hebrew University for Israels Water Authority. The study examined the contents of effluent that had undergone treatment and the treatments effectiveness. The study, which was carried out by researchers at Hebrew Universitys laboratory of environmental chemistry, was headed by Professor Ovadia Lev. Last week, representatives of the Water Authority's water quality department presented its main findings, together with those of other researchers in the field, to Environmental Protection Ministry officials. The study found that effluent in Israel has hundreds of pollutants of various kinds that include pharmaceuticals, flame retardants, substances used in x-ray diagnoses, industrial substances and a wide variety of pesticides. After purification, the concentration of these substances in the reclaimed water, which is used to water crops, is very low. But one substance carbamazepine, which is used to treat epilepsy withstands the purification process and remains in the reclaimed water. Its absence in tests of drinking water suggests that no effluent has penetrated the water source, making its presence an indication that reclaimed water is leaking into drinking water a health hazard … Continue reading

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First comprehensive and prospective characterization of a genetic subtype of autism

Posted: Published on June 12th, 2013

June 11, 2013 In the first prospective study of its kind, Seaver Autism Center researchers at the Icahn School of Medicine at Mount Sinai provide new evidence of the severity of intellectual, motor, and speech impairments in a subtype of autism called Phelan-McDermid Syndrome (PMS). The data are published online in the June 11 issue of the journal Molecular Autism. Mutation or deletion of a gene known as SHANK3 is one of the more common single-gene causes of autism spectrum disorders and is critical to the development of PMS, a severe type of autism. To date, clinicians have relied on case studies and retrospective reviews of medical records to understand the features of this disorder and how the clinical presentation relates to the extent of the genetic changes in the SHANK3 region. In the first systematic and comprehensive prospective trial, researchers led by Alex Kolevzon, MD, Clinical Director of the Seaver Autism Center, under the direction of Joseph Buxbaum, PhD, Director of the Seaver Autism Center, enrolled 32 participants with SHANK3 deletions to comprehensively assess their clinical symptoms and examine how the size of the SHANK3 deletion correlated to those symptoms. "Previous studies have not utilized prospective assessments to understand … Continue reading

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Mount Sinai researchers provide 1st prospective characterization of a genetic subtype of autism

Posted: Published on June 12th, 2013

Public release date: 11-Jun-2013 [ | E-mail | Share ] Contact: Press Office newsmedia@mssm.edu 212-241-9200 The Mount Sinai Hospital / Mount Sinai School of Medicine In the first prospective study of its kind, Seaver Autism Center researchers at the Icahn School of Medicine at Mount Sinai provide new evidence of the severity of intellectual, motor, and speech impairments in a subtype of autism called Phelan-McDermid Syndrome (PMS). The data are published online in the June 11 issue of the journal Molecular Autism. Mutation or deletion of a gene known as SHANK3 is one of the more common single-gene causes of autism spectrum disorders and is critical to the development of PMS, a severe type of autism. To date, clinicians have relied on case studies and retrospective reviews of medical records to understand the features of this disorder and how the clinical presentation relates to the extent of the genetic changes in the SHANK3 region. In the first systematic and comprehensive prospective trial, researchers led by Alex Kolevzon, MD, Clinical Director of the Seaver Autism Center, under the direction of Joseph Buxbaum, PhD, Director of the Seaver Autism Center, enrolled 32 participants with SHANK3 deletions to comprehensively assess their clinical symptoms … Continue reading

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