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FDA Approves Tekturna HCT(R) As Initial Treatment In Patients Unlikely To Achieve Their Blood Pressure Goals With A Single Agent
The US Food and Drug Administration (FDA) has approved Tekturna HCT((R)) (aliskiren and hydrochlorothiazide) tablets as initial therapy for patients who are likely to need multiple drugs to achieve their blood pressure goals. Tekturna HCT is a single-pill combination of Tekturna((R)) (aliskiren), the first and only approved direct renin inhibitor, and the diuretic hydrochlorothiazide (HCTZ), one of the most commonly-used high blood pressure medications.
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NIH Announces Final Guidelines For Federally Funded Embryonic Stem Cell Research
NIH on Monday announced final guidelines for assessing whether newly created embryonic stem cell lines can be used for federally funded research, as well as clarifying how old lines will be evaluated, CongressDaily reports (CongressDaily, 7/7). In March, President Obama overturned former President George W. Bush"s policy limiting federal funding of embryonic stem cell research to 21 lines. Obama asked NIH to develop new guidelines that would govern such research going forward. The agency received about 49,000 comments on a draft version of the guidelines announced in April (Vergano, USA Today, 7/7). The final guidelines, which take effect on Tuesday, state that stem cell lines used in federally funded research must come from embryos discarded after in vitro fertilization procedures. In addition, donors must have been informed that the embryo would be destroyed for stem cell research and made fully aware of other options, which include donating the embryo to other individuals for use in infertility treatments. Lastly, donors cannot be paid for an embryo, and no threats or other inducement can be part of the decision to donate (Vedantam, Washington Post, 7/7).Raynard Kington, acting director of NIH, said that lines developed before Tuesday likely would be approved if they were created in the spirit of the new rules, even if they do not follow them to the letter (Harris, New York Times, 7/7). NIH"s Advisory Committee to the Director will review such lines on a case-by-case basis. NIH also will create a registry of qualifying stem cell lines for use by researchers (Los Angeles Times, 7/7). Kington said, "Many of the lines already in existence may have met very rigorous standards of informed consent but may have been implemented in ways not consistent with the present guidelines." He added, "It"s unreasonable to retroactively apply procedures intended for future use" (New York Times, 7/7). Kington also said of the new guidelines, "We think this is a reasonable compromise to achieve the president"s goal of both advancing science while maintaining rigorous ethical standards. We believe that judgment is necessary" (Los Angeles Times, 7/7). Broadcast CoverageNPR"s "Morning Edition" on Tuesday reported on the stem cell guidelines (Shapiro, "Morning Edition," NPR, 7/7).
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HCL Anticipates Increasing Demand For Locums As NHS Funding Is Squeezed, UK
HCL, the UK"s largest health and social care recruiter, said today that it anticipates increasing demand for its temporary and locum staff as the NHS seeks to increase efficiencies in healthcare provision.
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Signature Genomic Laboratories Detects Chromosome Abnormalities In Individuals With Genetic Disorders Associated With Susceptibility To Cancer

Geneticists at Signature Genomic Laboratories recently demonstrated that microarray-based genetic testing can identify chromosome abnormalities that cause genetic disorders associated with susceptibility to cancer prior to the onset of symptoms. In their study, published in the May issue of Genetics in Medicine, geneticists from Signature reviewed data from 18,437 individuals who were tested by microarray analysis for unexplained mental retardation and congenital anomalies. DNA copy number gains or losses that encompassed gene regions associated with recognized genetic conditions with an increased risk for cancer were identified in 34 individuals. Almost three-quarters of those individuals had indications for study that were not specific to the diagnosed syndrome and therefore presumably did not have signs of cancer. The authors describe multiple instances in which early diagnosis improved medical management of the patient and allowed for early surveillance of cancer onset. "It is well known that microarray analysis allows for diagnosis of genetic syndromes at an early age that otherwise may not be diagnosed until onset of symptoms later in life," said Dr. Bassem A. Bejjani, M.D., Chief Medical Officer of Signature and senior author of the study. "However, this study shows the impact of early diagnosis is even more profound when a syndrome is associated with childhood-onset cancer, in which the threat of cancer is added to the child"s other medical issues." Signature Genomic Laboratories, LLC


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