NEW YORK, NY--(Marketwire - Mar 14, 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 Array Biopharma Inc. (
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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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Array Biopharma has recently announced a drug discovery collaboration agreement with Global Blood Therapeutics targeting chronic blood-based diseases. "We view this collaboration as a complement to our internal, broad based drug discovery research," said Brian W. Metcalf, Acting Chief Scientific Officer for Global Blood. "This relationship leverages Array's comprehensive drug discovery platform with Global Blood Therapeutics' class-leading expertise in blood biology, with the goal to revolutionize the treatment of chronic blood-based diseases."
PDL BioPharma is a biotech company with a patented process to create humanized antibodies. PDL engages in the management of antibody humanization patents and royalty assets, which consist of its Queen et al. patents and license agreements with various biotechnology and pharmaceutical companies.
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- Pharmaceuticals & Drug Trials