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Better FDA approval rate for small firms

Smaller pharma companies have a higher success rate in winning US approval for their drugs, according to research from Tufts University

Smaller pharma companies have a higher success rate when it comes to winning US Food and Drug Administration (FDA) approval for their drugs, according to newly released research from the Tufts Center for the Study of Drug Development at Tufts University.

Out of the top 50 pharma firms in the world, the bottom 40 do better than the top 10 when it comes to clinical approval success rate, which refers to the share of investigational new compounds entering clinical testing that eventually obtain FDA marketing approval.

However, the study found that the larger companies may still have a productivity advantage in that they tend to terminate a greater proportion of their clinical development failures early on in human trials, which means that the failures end up costing less and resources can be redirected to other projects.

The study looked at 1,734 compounds that entered clinical testing between 1993 and 2004. Among its additional findings were that small-molecule drugs accounted for 85 per cent of the drugs that entered clinical pipelines, but that large-molecule clinical approval success rates outpaced small molecules by about two-to-one.

In addition, the research identified the transition from phase II to phase III studies as a "substantial hurdle" for pharma companies of all sizes.

The full report is available for purchase from the Tufts Center for the Study of Drug Development: csdd.tufts.edu

10th September 2010

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