New study shows rate of US drug approvals lower than previously reported

15 February 2011

The overall success rate for drugs moving through clinical trials to US Food and Drug Administration approval from late 2003 to the end of 2010 is near one in 10. Previous reports, taken from earlier years, showed the rate of drug approvals is one in five to one in six.

Release of the study, conducted by the USA’s Biotechnology Industry Organization Industry Analysis and BioMedTracker (BMT) coincides with the 13th Annual BIO CEO & Investor Conference held in New York this week.

“This groundbreaking study highlights the depth and breadth of risk inherent in the drug development process more comprehensively than any other previous study,” said Alan Eisenberg, executive vice president of emerging companies and business development at the BIO, noting: “Knowing more about the magnitude of risk can lead to smarter drug development as well as smarter investing

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