How should we assess new antimalarial drugs?
Centocor, Inc., has announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response letter for its Biologics License Application (BLA) for ustekinumab. The application, filed by Centocor in late 2007, seeks approval to market ustekinumab as a subcutaneous biologic therapy for the treatment of adult patients with chronic moderate to severe plaque
Full Post: FDA issues complete response to biologics license application for ustekinumab
In recent years, the use of a three-day course of an antimalarial treatment called ACT (artemisinin-based combination therapy) in over 40 countries that face endemic malaria has shown great success in curing this deadly disease.
In a policy paper in this week’s PLoS Medicine, a team of researchers led by Steffen Borrmann (Kenya Medical Research Institute/Wellcome Trust Research Programme, Kilifi, Kenya) argues that the success of ACT “demands a new approach to the ways in which we assess new antimalarial drugs during clinical development and judge their potential utility for public health deployment.” The authors discuss the design and interpretation of clinical trials for new antimalarial drugs in the era of ACT. The policy paper is further discussed in an expert commentary by Colin Sutherland (London School of Hygiene and Tropical Medicine, UK).
A new debate in the open access journal PLoS Medicine questions whether all African children with fever should be treated presumptively with antimalarial drugs, or if treatment should wait until laboratory tests confirm malarial infection. Blaise Genton and colleagues from Tanzania contend that declining malarial transmission rates in parts of sub-Saharan Africa and the availability
Full Post: Debate on treating fevers in African children
Malaria, one of the oldest diseases known to man, has shown no signs of slowing down as it ages. More than 1 million children die from malaria in sub-Saharan Africa each year, and in areas along the Thailand/Cambodian border multiple drug-resistant strains of the disease are becoming commonplace. With the previously mainstay antimalarial drug chloroquine
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The next generation of case management guidelines for childhood illness need to be more locally informed, rather than relying on those centrally generated by organizations like the World Health Organization (WHO), argues a new essay published in the open access journal PLoS Medicine. Mike English and Anthony Scott from the KEMRI-Wellcome Trust Programme in Kenya
Full Post: Low-income settings require local guideline development for childhood illness
President-elect Barack Obama’s Health and Human Services Transition Team was presented with a series of nearly 50 legal and policy recommendations designed to combat the nation’s obesity epidemic. The document, developed by the Public Health Advocacy Institute (PHAI) at Northeastern University’s School of Law, was sent to the Transition Team by Richard Daynard, a professor
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Artemisinin combination therapies (ACTs) could be almost as effective in reducing transmission of malaria as insecticide-treated bednets (ITNs) in areas of low transmission, a study based on data from Tanzania has found. In high transmission areas, long-acting antimalarial regimens may be needed to achieve significant transmission reductions. Experts from the London School of Hygiene &
Full Post: Artemisinin combination therapies may be almost as effective as treated bednets in preventing malaria