FDA's New "Breakthrough" Designation Allows New Drugs to Gain Approval after Just 1 Round of Testing
Five Star Equities Provides Stock Research on Oncolytics Biotech and XOMA
NEW YORK, NY -- (Marketwire) -- 03/19/13 -- 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 Oncolytics Biotech, Inc. (NASDAQ: ONCY) (TSX: ONC) and XOMA Corp. (NASDAQ: XOMA).
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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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Oncolytics Biotech is focused on the development of oncolytic viruses for use as cancer therapeutics. The Company's lead product, REOLYSIN, a proprietary formulation of the human reovirus, is currently in late stage (Phase III) clinical testing in head and neck cancers. Oncolytics recently announced they have completed patient enrollment in their U.S. Phase 2 study of REOLYSIN in non-small cell lung cancer.
XOMA combines a portfolio of innovative therapeutic antibodies, both in late-stage clinical development and in preclinical research, with it's recently launched commercial operations. XOMA focuses its antibody research and development on allosteric modulation, which offers opportunities for new classes of therapeutic antibodies to treat a wide range of human diseases.
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