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Drugmakers Including GlaxoSmithKline (GSK) Scuttle Plan for Approval System Pushed by Biotechs


2/2/2012 8:08:10 AM

Drugmakers including GlaxoSmithKline Plc have fought off a U.S. senator’s proposal that would have approved medicines for diseases that are fatal, or have no existing treatments, based on fewer human trials. The plan, drafted by Democratic Senator Kay Hagan of North Carolina, was being pushed by biotechnology companies to speed up approvals and make the process less expensive. It would have created a program with the flexibility to allow drugs to be cleared based on any testing that shows they may be effective. This may include early trial results, interim data and use of so-called biomarkers that measure the effects of a molecule on biological functions linked to a disease.

Read at BusinessWeek


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