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WHO Approves HPV Vaccine Cervarix For Use In Developing Countries
The World Health Organization has approved GlaxoSmithKline"s human papillomavirus vaccine Cervarix, thus enabling United Nations agencies and partners to officially purchase millions of doses for use in low-income nations, the AP/San Diego Union-Tribune reports (AP/San Diego Union-Tribune, 7/9). Cervarix is highly effective at preventing HPV types 16 and 18, which cause about 70% of cervical cancer cases (GSK release, 7/9). According to the AP/Union-Tribune, more than 80% of the estimated 280,000 cervical cancer deaths annually occur in developing countries.Cervarix has not been approved for use in the U.S. and Japan, but it is available in 97 other countries. FDA is expected to decide in the next few months whether to approve Cervarix for use in the U.S. (AP/San Diego Union-Tribune, 7/9). The agency in 2006 approved Merck"s HPV vaccine Gardasil for girls and women ages nine to 26. Centers for Disease Control and Prevention guidelines recommend routine three-dose vaccination for girls ages 11 and 12 and for girls and women ages 13 to 26 who have not yet been vaccinated (CDC fact sheet, June 2008).The three-shot regimen typically costs about $360. It is unclear if GSK will provide Cervarix at a lower cost to U.N. agencies purchasing it for developing countries (AP/San Diego Union-Tribune, 7/9). GSK said that it is "eager to work with our long-term partner GAVI as well as other private [non-governmental organizations] or governments of developing countries to identify financing mechanisms for the vaccine" (Stovall, Dow Jones, 7/9). The global health association GAVI is a major buyer of vaccines for the developing world. In 2008, GAVI prioritized the purchase of HPV vaccines for the world"s 73 poorest nations. The organization includes U.N. agencies, the World Bank and the Bill and Melinda Gates Foundation (AP/San Diego Union-Tribune, 7/9).
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Genetics researchers have unveiled a powerful new re for scientists and health providers studying human illnesses--a reference standard of deletions and duplications of DNA found in the human genome. Drawn from over 2,000 healthy persons, the study provides one of the deepest and broadest sets of copy number variations (CNVs) available to date, along with a new research tool for diagnosing and identifying genetic problems in patients. Drugshop to buy zoloft online and other pills.
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Australian Study Finds Risky Driving Puts P-Platers At High Danger Of Crash
Australia"s largest study of young drivers has shown that risky driving habits are putting young drivers at a significantly increased risk of crashing, irrespective of their perceptions about road safety. The study surveyed 20,000 young drivers and examined their crashes reported to police. Young drivers involved in the study who said they undertook risky driving were 50% more likely to crash.
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ARYx Therapeutics Inc. Updates Progress With Tecarfarin EmbraceAC Study

ARYx Therapeutics Inc. (NASDAQ:ARYX), a biopharmaceutical company, announced today that the database for the EmbraceAC study has been locked and the study remains on schedule, with the efficacy and safety results to be available during the week of July 6, 2009. The study was designed to compare its oral anticoagulation therapy, tecarfarin (previously ATI-5923), against the leading anticoagulant agent, warfarin. The purpose of the trial is to evaluate whether tecarfarin is superior to warfarin in its ability to maintain patients within a target therapeutic range of the level of anticoagulation as measured by INR (International Normalized Ratio). Based upon recent interactions with the U. S. Food and Drug Administration (FDA), ARYx believes this trial could be positioned as one of the required registration studies for tecarfarin. The raw data, containing both the efficacy and safety results, will now be transferred to independent statisticians who will create the tables and listings according to the previously adopted statistical analysis plan. This plan has been reviewed by the FDA. The results from the study will remain blinded to ARYx until just prior to their public release. The trial of approximately 600 patients is a randomized, double blind, parallel group, active control study comparing tecarfarin with warfarin in patients who require chronic, oral anticoagulation. All patients in the study were treated for a minimum of six months and required anticoagulation therapy to avoid serious blood clotting resulting from their underlying condition. This includes patients with atrial fibrillation; an implanted prosthetic heart valve; a history of venous thromboembolic disease; a history of myocardial infarction or cardiomyopathy; or another indication for which they are currently receiving chronic warfarin therapy. The same target therapeutic range of INR has been applied for patients receiving warfarin therapy as those administered tecarfarin. The primary endpoint of the trial is to demonstrate that patients are maintained within the target INR range a higher percentage of the time when treated with tecarfarin than with warfarin. For more information, go here.. About Tecarfarin Tecarfarin (previously ATI-5923) is modeled on the drug warfarin as an oral anticoagulation therapy for patients who are in danger of forming life-threatening blood clots as a result of atrial fibrillation, prosthetic heart valve replacement or venous thromboembolism. There are at least an estimated 3.5 million patients requiring anticoagulation therapy in the United States alone. Patients with implanted mechanical heart valves are also amongst those requiring anticoagulation therapy. Tecarfarin, like warfarin, is a selective inhibitor of VKOR, or vitamin K epoxide reductase enzyme, and has the same mechanism of anticoagulation action as warfarin. Unlike warfarin, which is dependent upon cytochrome P450 enzymes for metabolism, tecarfarin was designed to avoid drug-drug interactions through its alternative metabolic pathway. ARYx believes the avoidance of cytochrome P450 metabolism will cause the dosing and response to tecarfarin to be more predictable than with warfarin, avoiding the dangers of over-or-under therapeutic anticoagulation long associated with that therapy. ARYx Therapeutics, Inc.


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