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Cephalon Submits NUVIGIL Supplemental New Drug Application For The Treatment Of Excessive Sleepiness Associated With Jet Lag Disorder
Cephalon, Inc. (Nasdaq: CEPH) announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) requesting approval of NUVIGIL(R) (armodafinil) Tablets [C-IV] for the indication of improved wakefulness in patients with excessive sleepiness associated with jet lag disorder resulting from eastbound travel. Jet lag disorder is an acute condition that occurs when a person"s internal body clock becomes disrupted as a result of rapid travel across several time zones. Based on U.S. Bureau of Labor Statistics findings, an estimated 70 million American travelers experience jet lag annually. Currently, there are no FDA-approved medications to improve wakefulness in travelers who experience the excessive sleepiness commonly associated with long flights.
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The Evolution Of Migraine From Episodic Headache To Chronic Disorder
Patients living with migraine have strong reason for new optimism concerning a positive future. Two review articles and an accompanying editorial, "The Future of Migraine: Beyond Just Another Pill," in the current issue of Mayo Clinic Proceedings, are the basis for an ironic premise.
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New Poll Finds Disease Prevention Is Top Priority For Americans In Health Reform
Trust for America"s Health (TFAH) and the Robert Wood Johnson Foundation (RWJF) released a new public opinion survey today which finds that Americans rank prevention as the most important health care reform priority, and overwhelmingly support increasing funding for prevention programs to reduce disease and keep people healthy.
Endocrinology

ADVTX Announces New Treatment For Bleeding After Nuclear Exposure

Advanced Therapeutics & Co. (ADVTX) announced that Fibrinoplate-S™ has shown efficacy in reducing the bleeding in animals exposed to extreme doses of radiation. Survivors of a nuclear event or a dirty bomb explosion will have similar damage from the ionizing radiation of such bombs. "Acute radiation can severely damage the bone marrow," Richard Yen, Ph.D., M.D., CEO of ADVTX explained. "While existing medications can boost the production of red cells and white cells from the recovering bone marrow, there is no effective treatment for low concentrations of platelets except through platelet transfusion. Donor platelets, however, may not be available or adequately screened for pathogens during times of distress." Viable Alternative to Platelet Transfusion ADVTX Fibrinoplate-S, a suspension formulation of human albumin spheres coated with a coagulation factor (fibrinogen), mimics the action of activated platelets. Random clots have not been observed even as bleeding improves after the administration of Fibrinoplate-S. In preclinical trials, Fibrinoplate-S reduced bleeding within 2 hours after a bolus intravenous administration in test subjects with less than 1% of the normal platelet count. The beneficial effects last at least 24 hours. There is no need to match the recipients" blood types. Fibrinoplate-S can be given to a large number of patients quickly. Availability ADVTX can scale up its production of Fibrinoplate-S quickly. Government agencies may include Fibrinoplate-S in their emergency response plans by submitting a "pre-EUA" (pre-Emergency Use Approval) to the US FDA. Licensing outside the United States is available. Visit http://www.ADVTX.com. Advanced Therapeutics & Co.


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