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In Older Adults, Hip And Back Fractures Increase Mortality Rates
If you are 50 or older and you break your hip, you have a one in four chance of dying within five years. Break your back, and you have a one in six chance of dying that soon, says a McMaster University study.
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CDC Prioritizes H1N1 Vaccinations For Pregnant Women
When the H1N1 flu vaccine becomes available in the fall, pregnant women should be among the first groups vaccinated because of their high risk for serious complications, a Centers for Disease Control and Prevention expert panel said on Wednesday, the Washington Post reports. The 15-member committee advises CDC on vaccine policy. The priority list also includes caretakers of infants, health care workers, children and young adults, and older people with chronic conditions. Anthony Fiore, a physician and epidemiologist at CDC, told the committee that about 6% of H1N1 deaths and hospitalizations are among pregnant women (Brown, Washington Post, 7/30). According to a CDC study published online Wednesday in the journal Lancet, pregnant women who contract the H1N1 virus -- also known as "swine flu" -- are at least four times more likely to be hospitalized than other people with the virus, the AP/Google reports. The study analyzed the first 34 U.S. cases, including six deaths, in pregnant women from April to mid-June of 2009. Although it is not clear if pregnant women are more susceptible to the virus, they have a higher risk of complications after becoming infected. The study"s authors said pregnant women suspected of having H1N1 should be administered Tamiflu as soon as possible, prior to the completion of diagnostic testing. CDC"s Denise Jamieson, the lead author of the study, said that Tamiflu appears relatively safe for pregnant women, despite limited safety data on its use in that population.Most pregnant women who contract H1N1 have mild flu symptoms like a cough or fever, according to the World Health Organization. Jamieson said that CDC does not recommend specific precautions for pregnant women but that doctors should act quickly -- preferably within 48 hours -- if a pregnant woman shows symptoms. She added that the pregnant women who died were basically healthy, and nearly all had viral pneumonia before experiencing acute respiratory problems prior to their death (Cheng, AP/Google, 7/29).CDC"s priority groups include about 159 million people out of a total U.S. population of more than 300 million, the Chicago Tribune reports. The agency expects to have about 120 million doses of the vaccine by the end of October. Officials are confident there will be enough for their target groups because only 20% to 50% of those recommended to receive seasonal flu vaccines seek them out. However, if supplies of the vaccine are unexpectedly restricted, the panel recommended that a smaller group -- about 41 million of the most susceptible to adverse side effects from infection or most likely to spread the virus -- be given priority for the vaccine. This smaller group also includes pregnant women (Maugh, Chicago Tribune, 7/30).
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Boston Scientific's Urology/Gynecology Products Featured In Studies At International Urogynecological Association Annual Meeting
Boston Scientific Corporation (NYSE: BSX) announced that results from nine studies involving the Company"s Urology/Gynecology products will be presented at the 34th Annual Meeting of the International Urogynecological Association (IUGA). Presentations will feature Boston Scientific"s pelvic floor reconstruction systems and mid-urethral sling systems used to treat pelvic floor prolapse and stress urinary incontinence (SUI). The Company will also sponsor a symposium highlighting long-term registry data comparing the benefits of experienced-based versus evidence-based outcomes for patients treated with mid-urethral slings. The IUGA Congress will be held June 16-20 at the Villa Erba Conference Center in Como, Italy.
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GlaxoSmithKline And Genmab Announce Top-line Results For Ofatumumab In Rheumatoid Arthritis

GlaxoSmithKline (GSK) and Genmab A/S (OMX: GEN) announced preliminary top-line results from a Phase III study of ofatumumab administered intravenously for the treatment of rheumatoid arthritis (RA) in patients who had an inadequate response to methotrexate. The study met the primary endpoint, ACR20 at 24 weeks, which indicates a 20 percent or greater improvement in the number of swollen and tender joints, as well as improvements in other disease-activity measures. In the study, 260 patients were treated and included in the analysis. At week 24, the ACR20 response rate was significantly greater for RA patients on ofatumumab (n=129) than on placebo (n=131) with a 50 percent response rate in the patients receiving ofatumumab, compared to 27 percent for patients on placebo (p-value less than 0.001). All key secondary endpoints were significant (p-value less than or equal to 0.001) There were no unexpected safety findings. The most common adverse events in the ofatumumab treated patients (greater than 5 percent) were rash, urticaria, nasopharyngitis, pruritus, throat irritation and hypersensitivity. Other than nasopharyngitis, these events generally occurred within 24 hours of the first infusion. One death, judged by the investigator as unrelated to ofatumumab, was reported in the study during the 24-week study period. "We have always believed in ofatumumab"s potential to make a difference in patients" lives. We are pleased with the results of this study, supporting the further investigation of this antibody"s promise in the treatment of RA" said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. "RA can be a highly debilitating disease. It is encouraging to see the reduction in disease symptoms achieved with intravenous ofatumumab, and we look forward to presenting the full study results, " said Carlo Russo, M.D., Senior Vice President, Biopharm Development, GSK. About the study In this 24 week double-blind study, patients with active RA were randomized to receive two 700 mg doses of intravenous ofatumumab or placebo two weeks apart in addition to background methotrexate. Disease status was measured every 4 weeks. Patients for this non-IND study were recruited from Europe, South America and Australia. The primary objective of the study was to determine the efficacy of intravenous ofatumumab in reducing the clinical signs and symptoms in RA patients after two 700 mg doses of ofatumumab compared to placebo. The primary endpoint of the study was ACR20 at 24 weeks. Other key secondary objectives included safety, patient reported outcomes, biomarkers and ACR 50 and ACR 70. ACR Response The ACR 20 response is defined as a 20 percent or greater improvement from baseline in tender and swollen joint counts, and 20 percent or greater improvement in 3 of the 5 following assessments: patient and physician global assessments, pain, disability, and an acute phase reactant (ESR or CRP). About ofatumumab Ofatumumab is a novel, investigational, fully human monoclonal antibody that targets a membrane-proximal (close to the cell surface) small loop epitope (a portion of a molecule to which an antibody binds) on the CD20 molecule of B-cells. This epitope is different from the binding sites targeted by other CD20 antibodies currently available. Ofatumumab is being developed for other indications under a co-development and commercialization agreement between Genmab and GlaxoSmithKline. It is not yet approved in any country. About GlaxoSmithKline (GSK) GlaxoSmithKline one of the world"s leading research-based pharmaceutical and healthcare companies is committed to improving the quality of human life by enabling people to do more, feel better, and live longer. GSK"s BioPharm R&D division has a rich early pipeline based on cutting edge molecular biology and genetic technology and a mature late-stage portfolio that will provide important medicines to oncology. GlaxoSmithKline


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