'Orphans' Hit Historic High At US FDA; More 'Me-Too' Drugs Urged

John Jenkins, director of the US Food and Drug Administration's Office of New Drugs, reported that 20 of the 42 new molecular entities or novel biologics approved so far in 2015 were medicines that had received orphan drug designation – an all-time high for those products since the enactment of the Orphan Drug Act in 1983.