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Abbott And AstraZeneca Submit New Drug Application To The FDA For CERTRIAD(TM), An Investigational Treatment For Mixed Dyslipidemia
Abbott (NYSE: ABT) and AstraZeneca announced that the companies have submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational compound for the treatment of mixed dyslipidemia, a combination of two or more lipid abnormalities including high LDL- cholesterol (the "bad" cholesterol), high triglycerides and low HDL-cholesterol (the "good" cholesterol). The NDA submission for this investigational compound, containing the active ingredients of CRESTOR(R) (rosuvastatin calcium) and TRILIPIX(R) (fenofibric acid), is supported by data from multiple studies, including efficacy and safety studies with the 5mg, 10mg and 20mg doses of rosuvastatin combined with fenofibric acid. Pending approval of the NDA, the treatment will be marketed as CERTRIAD(TM).
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IMPROVE Bill Seeks To Fight Medicare Fraud
Lawmakers push bill to fight Medicare fraud as part of health reform legislation.
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Better Diagnosis Of Diarrhea-Causing Bacteria: New Method Developed By Researchers From Helmholtz Center For Infection Research, Germany
It is based on detecting short, repetitive DNA segments in the genome of bacteria. Every single bacterial strain has such characteristic repeats. "With this method we are able to identify bacterial strains as well as clarify their genetic relationships. Furthermore, we can show how new pathogenic variants develop," says Manfred Hç¶fle, researcher at the HZI. The results have now been published in the current issue of the scientific journal Applied and Environmental Microbiology. The work is part of the two European Union funded projects "Healthy Water" and "AQUA-chip". Manfred Hç¶fle is coordinator of both projects that deal with various aspects of the microbiological safety of both, drinking water and sea water.
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Government Of Canada Approves A New Of Medical Isotopes

The Honourable Leona Aglukkaq, Minister of Health, announced the approval of a new of Technetium-99m (Tc-99m) for Canada. Health Canada has authorized Lantheus Medical Imaging of Boston, Massachusetts to use Molybdenum 99 (Moly-99) produced by the Open Pool Australian Light-water (OPAL) reactor to make Tc-99m for diagnostic imaging in Canadian health care facilities. Health Canada"s approval means that the Moly-99 produced by the OPAL reactor is safe and effective for use by Canadian health care providers. "This is very good news for Canadian health care providers and patients," said Minister Leona Aglukkaq. "Health Canada has been working hard to secure alternative supplies of medical isotope Moly 99 since the Chalk River shutdown occurred. Active engagement with the international community has produced results." Lantheus expects to begin receiving Moly-99 from the OPAL reactor over the next few weeks. The Tc-99m produced from this new supply will begin entering the Canadian supply chain as soon as possible. Rapid approvals for alternate supplies of isotopes were a part of the regulatory tool kit put in place after the 2007 Chalk River shutdown. Today"s announcement reflects just one of many measures the Government is undertaking to minimize the impact of the shortage on Canadians. Other measures being undertaken by Health Canada include: - Appointing Dr. Alexander (Sandy) McEwan as Special Advisor on Medical Isotopes for the duration of the isotope shortage. He will provide on-the-ground updates on the situation and how it is affecting patients, advise how Health Canada can best support provinces, territories and the medical community on the use of alternatives and mitigation strategies, and support the Minister in communicating the impact of the current shortage; - Collaborating with the provinces and territories and medical experts to produce guidelines to assist health care professionals in a shortage situation. These would include measures to make better use of available isotopes, prioritizing patients who most need testing, and shifting to viable alternatives where safe and effective to do so. These guidelines are based on work undertaken by the province of Ontario and draw on the medical expertise of the Ad Hoc Group of Experts on Medical Isotopes, as well as other health care providers; - Working closely with the Federal, Provincial, Territorial Working Group on Medical Isotopes, which is playing a key role in contingency planning and managing the shortage; and, - Reviewing regulatory requests for approvals of alternate isotopes on an urgent basis to provide health care providers with options as quickly as possible. This is part of Health Canada"s ongoing work on the medical isotope shortage to ensure that Canadians continue to have access to the highest standards of care. Other areas of focus include discussions with reactor operators abroad to ramp up production, expediting the regulation of isotope alternatives, and working with the medical community and provinces and territories on contingency plans to manage the shortage. Health Canada


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