Biotech Industry Looks to Benefit From FDA's New "Breakthrough" Designation
Five Star Equities Provides Stock Research on Cell Therapeutics and Santarus
(firmenpresse) - NEW YORK, NY -- (Marketwire) -- 03/14/13 -- 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 Cell Therapeutics Inc. (NASDAQ: CTIC) and Santarus, Inc. (NASDAQ: SNTS).
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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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CTI is committed to developing, acquiring, and commercializing innovative treatments for cancer. In their pursuit of making cancer more treatable, the company is developing a diversified portfolio of oncology products focused on identifying and developing new, less toxic, and more effective ways to treat cancer.
Santarus, Inc. is a specialty biopharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by physician specialists. Santarus' product development pipeline includes the investigational drug RUCONEST for treatment of acute attacks of hereditary angioedema. The company expects to submit a Biologics License Application to the FDA for RUCONEST in the first half of 2013.
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Datum: 14.03.2013 - 12:20 Uhr
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