SOURCE: Five Star Equities
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 Dendreon Corporation (NASDAQ: DNDN) and MannKind Corporation (NASDAQ: MNKD).
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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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Dendreon is a biotechnology company focused on targeting cancer and transforming lives through the discovery, development, commercialization, and manufacturing of novel therapeutics that may significantly improve cancer treatment options for patients. The company has announced a direct-to-consumer advertising campaign, with the first commercial set to air early in the second quarter.
MannKind is a biopharmaceutical company that focuses on the discovery, development and commercialization of therapeutic products for diseases such as diabetes and cancer. The company's drug delivery platform allows the delivery of medicines through the pulmonary route. The platform includes inhalation powders made with their Technosphere particles together with their novel inhaler devices.
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