NEW YORK, NY--(Marketwire - Mar 8, 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 Galena Biopharma Inc. (NASDAQ: GALE) and Keryx Biopharmaceuticals (NASDAQ: KERX).
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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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Galena Biopharma is focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using targeted biotherapeutics. Shares of the company have gained approximate 36 percent in the past year. Galena recently reported that a corporate update will be presented at the 7th Annual Bio-Europe International Partnering Conference by Mark W. Schwartz, Ph.D., Executive Vice President and COO.
Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of renal disease. Keryx is developing Zerenex (ferric citrate), an oral, ferric iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes.
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