New Programs Designed to Speed Up Approval Process a Key Factor in Biotech Industry's Growth in 2012
Five Star Equities Provides Stock Research on Ariad Pharmaceuticals and Opexa Therapeutics
(firmenpresse) - NEW YORK, NY -- (Marketwire) -- 03/27/13 -- Programs developed by the U.S. Food and Drug Administration to speed up the approval process have 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 have 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 Ariad Pharmaceuticals, Inc. (NASDAQ: ARIA) and Opexa Therapeutics Inc. (NASDAQ: OPXA).
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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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ARIAD is focused exclusively on cancer, specifically on small-molecule medicines that target proteins and pathways involved in cancer. The company recently received a positive opinion on the marketing authorization application for Iclusig from the Committee for Human Medicinal Products of the European Medicines Agency.
Opexa Therapeutics is a publicly traded biotechnology company dedicated to the development of patient-specific cellular therapies for the treatment of autoimmune diseases. The company's leading product candidate, Tcelna, has been granted Fast Track designation by the U.S. FDA for the Secondary Progressive multiple sclerosis indication.
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Datum: 27.03.2013 - 12:20 Uhr
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