FDA's New "Breakthrough" Designation Allows New Drugs to Gain Approval After Just 1 Round of Testing
Five Star Equities Provides Stock Research on InterMune and Questcor Pharmaceuticals
(firmenpresse) - NEW YORK, NY -- (Marketwire) -- 03/21/13 -- 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 InterMune Inc. (NASDAQ: ITMN) and Questcor Pharmaceuticals Inc. (NASDAQ: QCOR).
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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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InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and orphan fibrotic diseases. In pulmonology, InterMune is focused on therapies for the treatment of idiopathic pulmonary fibrosis (IPF), a progressive and fatal lung disease.
Questcor Pharmaceuticals provides drugs for the treatment of multiple sclerosis, nephrotic syndrome, and infantile spasms indications. Questcor's primary product is H.P. Acthar Gel, an injectable drug that is approved by the FDA for the treatment of 19 indications. The company reported shipments of Acthar during the fourth quarter 2012 increase 88 percent year-over-year to a total of 6,330 vials.
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Datum: 21.03.2013 - 12:20 Uhr
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