Popular Articles

Obesity And Diabetes Reduced By Common Allergy Drug In Mouse Model
Crack open the latest medical textbook to the chapter on type 2, or adult-onset, diabetes, and you"ll be hard pressed to find the term "immunology" anywhere. This is because metabolic conditions and immunologic conditions are, with a few exceptions, distant cousins.

More Countries Move Ahead With H1N1 Vaccine Testing
The race to develop a H1N1 (swine flu) vaccine before the fall flu season ramped up Wednesday, after Australia launched the first human trials of the H1N1 vaccine and scientists from the U.S., China and Britain announced plans for human trials of an H1N1 vaccine in coming weeks, AFP/France24.com reports (7/23).
News of the day
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).
Oncology

Rolofylline Did Not Demonstrate Efficacy For Acute Heart Failure In Clinical Trial

Merck & Co., Inc. said that preliminary results for the pivotal Phase III study of rolofylline (MK-7418), the Company"s investigational medicine for the treatment of acute heart failure, show that rolofylline did not meet the primary or secondary efficacy endpoints. While Merck will continue to analyze the data with outside experts, the Company will not file applications for regulatory approval this year. The results from this study will be presented at a medical meeting later this year. "Advances to help patients with acute heart failure, a disease that is the leading cause of hospitalization for patients over age 65 and that is associated with a high rate of mortality, have long been elusive," said Dan Bloomfield, M.D., executive director, cardiovascular research, Merck Research Laboratories. "These results are disappointing because we had been hopeful that blocking the adenosine A1 receptor with rolofylline would prove to be a useful new approach for these patients. "Merck remains committed to discovering and developing novel treatments for heart failure and for cardiovascular disease, which claim more than 17 million lives worldwide each year and remain the leading cause of death and a leading cause of disability," Dr. Bloomfield said. The primary hypothesis of the 2,033-patient pivotal Phase III study, PROTECT, was that rolofylline 30 mg would improve symptoms of acute heart failure compared to placebo. The secondary endpoints were that rolofylline 30 mg would reduce the risk of death or cardiovascular or renal re-hospitalization 60 days after treatment, and that rolofylline 30 mg would reduce the incidence of persistent kidney impairment. Details on the design of PROTECT are available at http://www.clinicaltrials.gov, identifiers NCT00328692 and NCT00354458. Rolofylline was acquired by Merck through NovaCardia, which Merck purchased in 2007. Results from the PROTECT pilot study, presented at previous medical meetings and published in 2008, had showed an overall trend toward efficacy (more patients with improved shortness of breath, fewer patients with worsening renal function and/or worsening heart failure). Merck"s late-stage pipeline of investigational medicines for cardiovascular disease includes MK-524A (approved in some markets outside the U.S.), MK-524B, ezetimibe/atorvastatin, and anacetrapib (MK-0859) for atherosclerosis, and vernakalant for atrial fibrillation. Merck


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