U.S. Food and Drug Administration Approved 30% More Drugs in 2012 Than the Year Previous RDInvesting Provides Stocks Research on Neostem and Hemispherx BioPharma
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01.03.2013 14:53:26 -
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Bloomberg recently reported drug approvals by the U.S. Food and Drug Administration reached a 15 year high in 2012. The FDA approved a total of 39 novel medicines last year, an increase of 30 percent when compared to a year ago. Oncology drugs lead the way with 11 new drugs approved last year. Over the last ten years the number of FDA approvals had averaged roughly 23 a year. The passage of the Prescription Drug User Fee Act (PDUFA) played a major role in the sharp increase in approvals.
The PDUFA "has provided critical resources for improving the quality and timeliness of premarket review of drugs," said FDA spokeswoman, Sandy Walsh. "These accomplishments could not have been achieved without the innovations of the biopharmaceutical industry and the dedication and skill of the FDA's drug review staff."
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NeoStem's most clinically advanced therapeutic, AMR-001, is being developed at Amorcyte, LLC, which they acquired in October 2011. Amorcyte is developing a cell therapy for the treatment of cardiovascular disease and is enrolling patients in a Phase 2 trial to investigate AMR-001's efficacy in preserving heart function after a heart attack.
Hemispherx's platform technology includes components for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection). The company earlier this month reported that the FDA has declined its New Drug Application for Ampligen for Chronic Fatigue Syndrome.
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