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.


Related Content

Times Have Changed: FDA Ends ESA REMS Ahead Of First Biosimilars



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

All set! This Question has been sent to my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Add a personalized Question to your Analyst