SOURCE: The Bedford Report
NEW YORK, NY--(Marketwire - Jun 30, 2011) - Recent studies suggest that the FDA has begun approving cancer drugs at a faster rate. This is welcome news for early stage drug developers -- many of which struggle to secure the necessary capital to maintain operations. The Bedford Report examines the outlook for companies in the Healthcare Sector and provides equity research on Cell Therapeutics, Inc. (NASDAQ: CTIC) and Oncothyreon, Inc. (NASDAQ: ONTY). Access to the full company reports can be found at:
Studies from the Friends of Cancer Research advocacy group find that new cancer drugs are approved in just six months on average in the United States -- half the time it takes for the same drugs to be approved in Europe. "When we realized we were correct, we thought, 'No one is going to believe us because this goes against urban legend,'" said Ellen V. Sigal, chairwoman and founder of Friends of Cancer Research.
User fees from the Prescription Drug User Fee Act of 1992 have helped provide the FDA with resources to shorten drug review times. The Act is up for reauthorization next year, and the Friends of Cancer Research argue that the speed of drug review times might not be as high a priority as achieving other objectives in advance regulatory science.
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Cell Therapeutics' lead cancer drug candidate is "pixantrone" for relapsed or refractory aggressive non-Hodgkin's lymphoma. Pixantrone is currently under review in the European Union for the indication and Cell Therapeutics will re-submit a new drug application to the US Food and Drug Administration (FDA) later in 2011.
Oncothyreon is a biotechnology company specializing in the development of innovative therapeutic products for the treatment of cancer. The company's "Stimuvax" cancer vaccine is designed to induce an immune response to cancer cells and is currently in phase 3 trials.
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