FDA's New "Breakthrough" Designation Allows New Drugs to Gain Approval After Just 1 Round of Testing
Five Star Equities Provides Stock Research on AEterna Zentaris and Amicus Therapeutics
(firmenpresse) - NEW YORK, NY -- (Marketwire) -- 03/13/13 -- Programs developed by the U.S. Food and Drug Administration to speed up the approval process has been a major driver for growth within the Biotech Industry. In 2012, FDA drug approvals totaled a 15-year high of 39, over the past decade drug approvals has averaged roughly 23 a year, according to a recent Bloomberg article. Five Star Equities examines the outlook for companies in the Biotechnology Industry and provides equity research on AEterna Zentaris Inc. (NASDAQ: AEZS) and Amicus Therapeutics, Inc. (NASDAQ: FOLD).
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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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AEterna Zentaris pipeline encompasses compounds at all stages of development, from drug discovery through to marketed products. Shares of the company fell sharply earlier this week after announcing it will discontinue its Phase 3 trial of perifosine for the treatment of multiple myeloma following a recommendation from an independent Data Safety Monitoring Board.
Amicus Therapeutics is a biopharmaceutical company at the forefront of developing therapies for rare and orphan diseases. The Company is developing orally administered, small molecule drugs called pharmacological chaperones, a novel, first-in-class approach to treating a broad range of human genetic diseases. Amicus expects to release 12-month results from their ongoing Phase 3 Fabry disease monotherapy study in the third quarter of 2013.
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Datum: 13.03.2013 - 12:20 Uhr
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