An antibiotic and a protein can work together to fight radiation-induced infections better than either can manage alone. Doctors already use antibiotics to treat radiation sickness. But the addition of a protein from the immune system — bactericidal/permeability-increasing protein (BPI), which acts against poisons called endotoxins — improves the survival rate of irradiated mice, according to a study published today in Science Translational Medicine Continue reading Dynamic duo helps to heal irradiated mice
Tag Archives: Health
Transatlantic PML
The European Medicine Agency and US Food and Drug Administration (FDA) published in September the proceedings of a joint workshop held to address questions related to progressive multifocal leukoencephalopathy (PML), a rare and sometimes fatal brain disease that can occur as an adverse drug reaction to some therapeutics that affect immunological functions. The meeting attended by 170 regulators, academic scientists, funding bodies and clinical researchers, called for work on animal models, predictive biomarkers and long-term studies. “No one company is going to answer all the questions; they’re going to be answered by research consortia,” says co-convener and European Medicines Agency (EMA) pharmacovigilance head Peter Arlett. Continue reading Transatlantic PML
E. coli crisis opens door for Alexion drug trial
This spring’s outbreak of a virulent form of Escherichia coli in Germany and France provoked a rapid response from public health authorities and the research community. Not only did the response represent a triumph of global collaboration in rapidly characterizing the Shiga toxin–producing strain but it also prompted an on-the-fly clinical trial of one of the world’s most expensive biotech drugs—Alexion’s humanized monoclonal antibody Soliris (eculizumab)—previously approved for the rare disease paroxysmal nocturnal hemoglobinuria (PNH). As thousands fell ill with the enterohemorrhagic E. coli (EHEC) strain O104:H4 from eating tainted food—a substantial fraction developing potentially fatal hemolytic uremic syndrome (HUS)—German and then French doctors turned to Soliris, which prevents the cleavage of complement component 5 (C5) and activation of the hemolytic cascade.
Continue reading E. coli crisis opens door for Alexion drug trial
Overwhelmed drug regulators seek cure in cooperation
Regulatory authorities such as the US Food and Drug Administration and European Medicines Agency face continual criticism for their plodding pace of drug approval decisions. In 2009, the last year for which complete data are available, the median time for a standard review of a drug application in the US was 13 months—30% longer than the agency’s target for such reviews. But even with this situation, it’s undeniable that both agencies devote far more human and financial resources to the process than most other countries can afford to spend on their own.
To keep up, many other medical regulatory authorities are banding together with one another to share the expertise and clinical results needed to make faster decisions. Continue reading Overwhelmed drug regulators seek cure in cooperation