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
Tag Archives: Business
NASA to Launch Guidelines to Protect Lunar Artifacts
NASA is unlikely to be the operator of the next spacecraft to land on the moon, but the U.S. space agency is considering sending along some red tape.
As dozens of private teams race to return to the moon as soon as next year, spurred on by $30 million in prize money from Google and the X Prize Foundation, NASA is wrestling with how to safeguard the historic and scientific value of more than three dozen sites containing remnants of America’s golden era of space exploration, including the spot where Neil Armstrong and Edwin “Buzz” Aldrin Jr. left the first footprints on the lunar surface. Later this month, the agency plans to issue what it calls “recommendations” for spacecraft, or future astronauts, visiting U.S. government property on the moon. Continue reading NASA to Launch Guidelines to Protect Lunar Artifacts
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
Greening Mortar With Olive Waste
The cement industry is one of the world’s largest producers of atmospheric carbon dioxide. The reason is that cement’s calcium carbonate releases the greenhouse gas. Now researchers have shown that they can replace up to 10% of the cement in mortar mixtures without harming the strength of the widely used masonry paste. The cement’s replacement is environmentally friendly, to boot: a waste product from olive oil production (Environ. Sci. Technol., DOI: 10.1021/es200968a).