Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

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

This article was originally published in SRA

Executive Summary

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.