NEW YORK, NY -- (Marketwire) -- 03/18/13 -- 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 ArQule, Inc. (NASDAQ: ARQL) and Vanda Pharmaceuticals Inc. (NASDAQ: VNDA).
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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ArQule is a clinical-stage biotechnology company that is researching and developing innovative cancer therapeutics targeting critical biological processes implicated in a wide range of cancers. The Company's assets include tivantinib (ARQ 197) a lead product in Phase 3 clinical testing. The Company also has a pipeline of early clinical-stage and pre-clinical product candidate.
Vanda Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of products for the treatment of central nervous system disorders to address unmet needs. The company has recently announced it has withdrawn its Marketing Authorization Application for its schizophrenia drug, Fanaptum, in the European Union.
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