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Federal court backs Teva Pharmaceutical patents behind MS treatment Copaxone

Posted: Published on June 26th, 2012

Shares of Teva Pharmaceutical Industries Ltd. climbed Monday in the first trading day after a U.S. federal court reaffirmed patents protecting the drugmaker's biggest brand-name product, the multiple sclerosis treatment Copaxone. The Israeli company said Saturday the decision from the U.S. District Court for the Southern District of New York covers several patents, the last of which expires in 2015, and that it prevents other drugmakers from selling their versions of the drug until then. It also said the decision should prevent the Food and Drug Administration from approving generic versions of the drug until 2014. U.S.-traded shares of the company rose 4.5 per cent, or $1.71, to close at $39.72, while the Standard & Poor's 500 index fell 1.6 per cent. Teva had sued Mylan Laboratories Inc., Momenta Pharmaceuticals Inc., Sandoz Inc. and Natco Pharmaceuticals, accusing the rival companies of infringing on patents covering the drug's chemical composition, method of use and the manufacturing process behind the product. Teva is the 10th largest global pharmaceutical company, according to drug data firm IMS Health, and Copaxone is its main brand-name offering. It expects $3.8 billion in sales this year from the drug. Teva is primarily a maker of generic drugs. … Continue reading

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The silent treatment: How Canada has failed MS sufferers

Posted: Published on June 26th, 2012

Here at Maclean's, we appreciate the written word. And we appreciate you, the reader. We are always looking for ways to create a better user experience for you and wanted to try out a new functionality that provides you with a reading experience in which the words and fonts take centre stage. We believe you'll appreciate the clean, white layout as you read our feature articles. But we don't want to force it on you and it's completely optional. Click "View in Clean Reading Mode" on any article if you want to try it out. Once there, you can click "Go back to regular view" at the top or bottom of the article to return to the regular layout. Beatrice de Gea/The New York Times On June 3, 2010, Peter Liu, a scientific director of the Canadian Institutes of Health Research (CIHR) in Ottawa, sent an internal email outlining his thoughts on a procedure causing medical and political schismsand inciting patient activism. Liu, head of the Institute of Circulatory and Respiratory Health, was responding to CIHR executives request for his opinion about chronic cerebrospinal venous insufficiency, or CCSVI, a condition identified by Paolo Zamboni in 2008. Zamboni, director of vascular … Continue reading

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New Findings from REPLACE Study Support Potential of Natpara(TM) to Treat Adult Hypoparathyroidism

Posted: Published on June 26th, 2012

BEDMINSTER, N.J.--(BUSINESS WIRE)-- NPS Pharmaceuticals, Inc. (NPSP), a specialty pharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, announced today that new findings from the double-blind, placebo-controlled Phase 3 REPLACE study of Natpara (recombinant human parathyroid hormone (rhPTH [1-84])) support the drugs therapeutic potential as the first parathyroid hormone replacement therapy for adults with hypoparathyroidism. The findings were presented in oral and poster sessions at the ENDO 2012 annual meeting of The Endocrine Society in Houston, TX. Natpara is a bioengineered replica of human parathyroid hormone that is being developed by NPS Pharmaceuticals as the first replacement therapy for adults with hypoparathyroidism. These presentations show the potential benefits of replacing the missing parathyroid hormone with Natpara and restoring and maintaining healthy serum calcium levels in patients with this rare and complex metabolic disorder, said Roger Garceau, M.D., senior vice president and chief medical officer of NPS Pharmaceuticals. The consequences of this disorder can be severely disabling, which is why the drugs apparent treatment effects in this study increased serum calcium levels, reductions in calcium and vitamin D supplementation, fewer disease symptoms and increased bone turnover are so impressive. Natpara was also well tolerated, with no significant differences in … Continue reading

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Investigational hormone replacement promising treatment for rare disorder

Posted: Published on June 26th, 2012

Public release date: 23-Jun-2012 [ | E-mail | Share ] Contact: Aaron Lohr alohr@endo-society.org 240-482-1380 The Endocrine Society An investigational parathyroid hormone replacement effectively treated a rare disorder characterized by low calcium and high phosphate levels in the blood, a new study finds. The results will be presented Saturday at The Endocrine Society's 94th Annual Meeting in Houston. The parathyroid hormone replacement is called recombinant human parathyroid hormone, or rhPTH(1-84). It is produced in the lab using a replica of the human parathyroid hormone gene. rhPTH(1-84) is identical to the naturally occurring parathyroid hormone and acts to regulate calcium levels in the same way. Calcium is an essential mineral for bone, teeth, and muscle health, among other things. In the rare and complex disorder known as hypoparathyroidism, or HypoPARA, the parathyroid gland produces insufficient parathyroid hormone. As a result, calcium levels drop, while the amount of phosphate, another mineral, increases in the body. This mineral imbalance can cause a number of symptoms, including muscle twitching, spasms, and pain; seizures; cramps in the hands and feet; fatigue; anxiety; depression; and problems with bone and tooth development. Current options are limited to symptom management with calcium and active vitamin D in high … Continue reading

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Testosterone-replacement therapy improves symptoms of metabolic syndrome

Posted: Published on June 26th, 2012

ScienceDaily (June 25, 2012) Hormone-replacement therapy significantly improved symptoms of metabolic syndrome associated with testosterone deficiency in men, a new study from Germany finds. The results will be presented June 25 at The Endocrine Society's 94th Annual Meeting in Houston. Metabolic syndrome comprises a cluster of complications that can increase the risk of heart and blood-vessel disease as well as type 2 diabetes. These complications include excess body weight, especially around the waist and torso, and abnormal concentrations of fat in the blood, known as lipids. In particular, patients with metabolic syndrome have high blood levels of the so-called bad fats, or triglycerides and low-density lipoproteins, and insufficient amounts of the healthy fats known as high-density lipoproteins. In addition, they often have high blood pressure and sugar, or glucose, levels. Previous research has linked metabolic syndrome to testosterone deficiency, which can cause decreased muscle and bone mass, depression, low energy, and decreased sex drive and ability. In addition, testosterone deficiency is also associated with the individual symptoms of metabolic syndrome, even when they are present without the other complications. "When indicated, testosterone treatment is both essential and safe in elderly patients with symptomatic late onset hypogonadism, or testosterone deficiency," said … Continue reading

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Pathway Genomics Partners with DASA, the Largest Private Medical Diagnostics Company in Brazil

Posted: Published on June 26th, 2012

SAN DIEGO--(BUSINESS WIRE)-- Pathway Genomics Corporation, a San Diego-based genetic testing laboratory, has partnered with Diagnsticos da Amrica (DASA), the largest private medical diagnostics company in Latin America and the fourth largest provider of diagnostic services in the world. Based in Brazil, DASAs clinical analysis division collects samples from more than 500 patient service centers and has 11 central laboratories. DASAs brands include Alta Excelncia Diagnstica, Delboni Auriemo, Lavoisier, CDPI, Srgio Franco, Pasteur, Exame and others. Through this partnership, physicians have access to Pathways valuable genetic testing services, bringing additional personalized care to more than 180 million people in Brazil. Pathways vision is to responsibly reveal personalized and actionable genetic information in order to globally educate, inform and improve health and well-being, said Dr. Michael Nova, Pathways chief medical officer. Our alignment with DASA is a major part of this vision, and we are excited to help bring this scientifically-advanced technology to the people of Brazil. Specifically, through DASA, physicians in Brazil now have access to multiple genetic tests, including: The partnership between DASA and Pathway represents a milestone in Brazilian medicine, ensuring access to predictive genetic tests through an advanced and innovative technology, said Dr. Octvio Fernandes, DASAs chief … Continue reading

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Penn Medicine HIT expert: Patient expectations ahead of current EHR capabilities

Posted: Published on June 26th, 2012

Brian Wellss job is to make big data and technology issues disappear for the researchers at the Perelman School of Medicine. He is building the technical infrastructure needed to achieve the goals of personalized medicine regarding biobanking and genetic sequencing. This associate chief information officer for Health Technology and Academic Computing at Penn Medicine recently spoke with MedCity News about some new developments at Penn including his thoughts on the challenge of sharing electronic medical records. What have been some of the unforeseen consequences of the growth of information technology in healthcare? There will be increasing desire to provide access to all that information the problem is we dont have unified standards for access. So the exchange of real data discretely is very difficult today. What we call a white blood cell count at Penn is probably different than what Geisinger calls it and thats just one lab test. The exchange and utilization of data that can be acted on electronically is pretty constrained. We have many ways to record information, but not as many common ways to share information. For example, there may be as many as 10 coding systems. LOINC is the industry standard for lab tests. In … Continue reading

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Bioheart's Chief Science Officer Kristin Comella Presents at 10th Annual Meeting of International Society for Stem …

Posted: Published on June 26th, 2012

SUNRISE, Fla., June 25, 2012 (GLOBE NEWSWIRE) -- Bioheart, Inc. (BHRT.OB) announced today that Kristin Comella, the company's Chief Science Officer presented at the 10th Annual Meeting of the International Society for Stem Cell Research (ISSCR) in Yokohama, Japan June 13 - 16, 2012. One of the world's premier stem cell research events, the ISSCR format includes international research and poster presentations from invited speakers, exceptional peer-to-peer learning and unparalleled networking opportunities. Comella presented a poster on clinical applications of adipose or fat derived stem cells (ADSCs). The ISSCR annual meeting serves as the largest forum for stem cell and regenerative medicine professionals from around the world. Through lectures, symposia, workshops, and events attendees experience innovative stem cell and regenerative medicine research, advances and what's on the horizon. The meeting features more than 1,000 abstracts, nearly 150 speakers and provides numerous networking and professional development opportunities and social events. For additional information, visit http://www.isscr.org. Kristin Comella has over 14 years experience in corporate entities with expertise in regenerative medicine, training and education, research, product development and senior management including more than 10 years of cell culturing experience. She has made a significant contribution to Bioheart's product development, manufacturing and quality … Continue reading

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NeoStem Awarded NIAID Research Grant for the Development of VSEL Technology for Radiation Exposure

Posted: Published on June 26th, 2012

NEW YORK, June 25, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE MKT:NBS) ("NeoStem" or the "Company"), a cell therapy company, today announced that it has been awarded a two year grant totaling $595,252 for the "Development of Human, Autologous, Pluripotent Very Small Embryonic Like (VSELs) Stem Cells as a Countermeasure to Radiation Threat" from the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH). This peer reviewed grant was awarded to support research to be headed by Denis O. Rodgerson, Ph.D., Director of Stem Cell Science for NeoStem and Mariusz Ratajczak, M.D., Ph.D., who is the head of the Stem Cell Biology Program at the James Graham Brown Cancer Center at the University of Louisville and co-inventor of VSELTM Technology. This award will fund studies to investigate the potential of very small embryonic-like stem cells as a countermeasure to radiological and nuclear threat. The product candidate, which is an autologous stem cell therapy derived from the patient's own stem cells, will be developed to rescue patients who have been exposed to radiation due to nuclear accident or terrorist threat and to treat cancer patients who have undergone radiation therapy and who consequently … Continue reading

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FDA report faults Houston-area stem-cell company

Posted: Published on June 26th, 2012

The Sugar Land company involved in Gov. Rick Perry's unlicensed adult stem-cell procedure is rife with basic manufacturing problems, according to the U.S. Food and Drug Administration. In a report one expert called a blow to the entire adult stem-cell industry, the FDA found that Celltex Therapeutics Corp. cannot guarantee the sterility, uniformity and integrity of stem cells it takes from people and then stores and grows for eventual therapeutic reinjection. "You have not performed a validation of your banking and thawing process to assure viability" of the stem cells, reads the April 27 report, meaning that the company cannot verify the cells are alive. The FDA report, which followed an April 16-27 inspection of Celltex, was released under the Freedom of Information Act Monday to the Houston Chronicle and a University of Minnesota bioethicist who complained in February that Celltex is a potential danger to patients and not in compliance with federal law. The report, partially redacted, was not accompanied by a warning letter. A former FDA official who read it, however, said the deficiencies - 79 in all, from incorrectly labeled products to failed sterility tests - are so serious that Celltex risks being shut down if it … Continue reading

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