ABILITY PHARMACEUTICALS of Barcelona, Spain, received orphan-drug designation from FDA for ABTL0812, for the treatment of pancreatic cancer. This regulatory milestone comes after the ODD in the pediatric cancer neuroblastoma granted by EMA and FDA in 2015. In preclinical studies, ABTL0812 have shown efficacy in pancreatic cancer as single agent and synergistic effect (by 8...
Richard Pazdur, FDA’s top oncologist who last week received a battlefield promotion to the role of director of the FDA Center for Drug Evaluation and Research, is described as a stabilizing figure respected by major patient groups, oncology professional societies, and the industry.
