NEW YORK, NY--(Marketwire - Mar 13, 2013) - 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 Affymax, Inc. (
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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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Affymax, our mission is to discover, develop and deliver innovative therapies that improve the lives of patients with kidney disease and other serious and often life-threatening illnesses. Shares of the company fell sharply last month after announcing a nationwide voluntary recall of all lots of OMONTYS (peginesatide) Injection.
DARA Biosciences is a specialty pharmaceutical company focused on the development and commercialization of oncology treatment and supportive care products. The company in November submitted an Orphan Drug Application to the FDA for KRN5500. KRN5500's Fast Track status was approved in 2011.
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- Pharmaceuticals & Drug Trials