Advanced Cell Tech and Ariad Pharmaceuticals -- Highly Scrutinized But Poised for Growth
The Bedford Report Provides Equity Research on Advanced Cell Technology and Ariad Pharmaceuticals
(firmenpresse) - NEW YORK, NY -- (Marketwire) -- 10/05/11 -- In recent years the FDA has been heavily scrutinized for making the approval process more difficult for drug developers. A groundbreaking study released this year by the BIO and BioMedTracker finds that the overall success rate for drugs moving through clinical trials to FDA approval from late 2003 to the end of 2010 is a mere 10 percent. The Bedford Report examines the outlook for companies in the Biotechnology Industry and provides equity research on Advanced Cell Technology, Inc. (OTCBB: ACTC) and Ariad Pharmaceuticals, Inc. (NASDAQ: ARIA). Access to the full company reports can be found at:
Previously, the rate of approval was one in five to one in six. Oncology drugs faced the toughest road to approval despite the fact that the disease area is the most closely studied in all of drug development.
Janet Woodcock, the head of the FDA's drug division, is quick to dismiss concerns regarding the FDA's approval process. This summer in testimony before the House Energy and Commerce's health subcommittee, Woodcock explained the agency meets more than 90% of deadlines that are part of the drug-review process. She also said so-called first cycle approvals are at a 20-year high, with more than two-thirds of new drugs being approved within the six-to-10-month time frame given to new drug applications.
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With scrutiny in the US remaining high, Advanced Cell Technology has focused on Europe of late. The company announced last month that it has received clearance from the U.K. Medicines and Healthcare Products Regulatory Agency to begin treating patients as part of a Phase 1/2 clinical trial for Stargardt's Macular Dystrophy using retinal pigment epithelium derived from human embryonic stem cells. The European Medicines Agency previously granted Orphan Drug designation for the company's RPE cell product for use in treating SMD.
Recently, Ariad Pharmaceuticals, in partnership with Merck, announced positive results from a Phase 3 study of its sarcoma drug, ridaforolimus. Studies showed a 28 percent reduction in the risk of progression or death in those treated with ridaforolimus compared to placebo.
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Datum: 05.10.2011 - 06:16 Uhr
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