Novartis' drug Revolade was associated with increases in platelet counts and reductions in bleeding in a long-term trial involving patients with chronic and persistent immune thrombocytopenia.
Participants in a recent FDA Patient Engagement Advisory Committee meeting discussed barriers to increasing patient engagement in medical device clinical trials. Ideas for overcoming common barriers included creating a framework to improve public understanding of the clinical trial process, using plain language in clinical trial descriptions and consent forms, improving sponsors' engagement with community institutions and designing trials to be less burdensome for participants.
When starting or improving a lab stewardship program, it's important to consider interventions, governance, strategies for improvement, and data extraction and monitoring. "The obvious place to begin is to put together a multidisciplinary laboratory stewardship committee" that is "linked to leadership by including the chief medical officer and chief financial officer (CFO) or their designees as key members," says Jane Dickerson, director of reference lab services at Seattle Children's Hospital.
The government of Nigeria has begun a campaign to vaccinate 874,000 people in the states of Kwara and Kogi against yellow fever, according to the World Health Organization. The campaign was launched Friday and will focus on residents between the ages of 9 months and 45 years old.
Health Union's third annual Hepatitis C in America survey found that factors such as treatment cost, lack of insurance and anxiety about side effects were among the main obstacles to treatment. Of 609 respondents, 62% knew what hepatitis C was before their diagnosis and 33% did not.
Instrumentation Laboratory's HemosIL AcuStar HIT-IgG(PF4-H) assay has received clearance from the FDA for the detection of heparin-induced thrombocytopenia.
Florida health officials say the state's first case of locally transmitted Zika virus infection in 2017 has been reported, involving a mosquito transmission from a person who traveled to Cuba to a partner in Manatee County. The state has reported 187 confirmed cases of Zika virus infection for the year, most of them travel-related.
Two Ebola vaccine candidates tested in Liberia yielded immune responses that lasted at least one year and did not pose major safety concerns in patients with no history of Ebola, researchers reported in the New England Journal of Medicine. The study compared an adenovirus-based vaccine developed by GlaxoSmithKline and the National Institute of Allergy and Infectious Diseases, and a recombinant vesicular stomatitis virus-based vaccine developed by Canadian researchers and licensed by Merck.
HIV-positive individuals who take antiretroviral therapy and have undetectable viral loads have not transmitted HIV to HIV-negative partners in clinical trials, according to a CDC "Dear Colleague" letter. The findings were based on a review of three studies involving thousands of couples.
Scientists have created special stem cells from the cells of very young mouse embryos that may one day be used to help prevent miscarriages, according to findings published in Nature. A mixture of chemicals keeps these stem cells, called expanded-potential stem cells, or EPSCs, in a young state that allows researchers to "erase all memories in these cells and take them back to the equivalent of a blank piece of paper," says study lead author Pentao Liu.