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 →