Insufficient Women Enrolled In Clinical Trials For Heart Devices

Despite a long-standing requirement for medical device makers to include women in studies they submit to the Food and Drug Administration for device approval, only a few include enough women or analyze how the devices work specifically in women, according to research reported in Circulation: Cardiovascular Quality and Outcomes…

BioSante Pharmaceuticals Reports Positive LibiGel(R) Safety Data In Phase III Clinical Program

BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX), announced that the independent Data Monitoring Committee (DMC) of the ongoing LibiGel® Cardiovascular (CV) and Breast Cancer Safety Study unanimously recommended study continuation without modifications, after its third review of the study’s unblinded safety data. The review was based on data from almost 1,500 women-years of exposure…

New Perspectives on Menopausal Hormones and Heart Disease

July 18, 2007 presentation by Marcia Stefanick for the Stanford School of Medicine Medcast lecture series. Recent Women’s Health Initiative (WHI) studies demonstrated that hormone therapy carries a number of health risks in woman not considered earlier, such as the increased likelihood of blood clots and stroke. Marcia Stefanick, PhD, professor of medicine at Stanford School of Medicine, served as chair of the WHI steering committee and she continues to analyze the project’s data for other …