Yahoo News March 15, 2013 ( Friday )
FDA's New "Breakthrough" Designation Allows New Drugs to Gain Approval After Just 1 Round of Testing
Five Star Equities Provides Stock Research on ACADIA Pharmaceuticals and BioCryst Pharmaceuticals
The FDA's new "breakthrough" product designation allows new drugs to win approval after just a single round of testing, instead of the usual three. A total of three promising experimental medicines have been assigned the new status so far, while an additional 18 drugs have applied. The new designation follows three other programs -- Fast Track, Priority Review and Accelerated Approval -- each of which were designed to help bring crucial new drugs to market in a shorter amount of time.
"A breakthrough drug is one that may offer important new benefits for patients with serious or life-threatening disease who are especially in need of new safe and effective treatments," said Janet Woodcock, director of FDA's Center for Drug Evaluation and Research.
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ACADIA is a biopharmaceutical company focused on innovative treatments that address unmet medical needs in neurological and related central nervous system disorders. ACADIA has a pipeline of product candidates led by pimavanserin, which is in Phase III development as a potential first-in-class treatment for Parkinson's disease psychosis.