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 Inovio Pharmaceuticals Inc. (NYSE: INO) and Omeros Corporation (NASDAQ: OMER).
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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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Inovio-s synthetic vaccine technology platform is applicable to cancers and infectious diseases. To date the company has developed vaccine product candidates for cervical dysplasia/cancer, prostate cancer, hepatitis C virus, HIV, influenza, malaria and tropical diseases. Their lead program in cervical dysplasia is in Phase II.
Omeros most clinically advanced product candidates are derived from their proprietary PharmacoSurgery platform designed to improve clinical outcomes of patients undergoing arthroscopic, ophthalmological, urological and other surgical and medical procedures. The company currently has three PharmacoSurgery programs in clinical development.
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