Oncothyreon and Keryx Look to Benefit From Positive FDA Trends
The Bedford Report Provides Equity Research on Oncothyreon & Keryx Biopharmaceuticals
(firmenpresse) - NEW YORK, NY -- (Marketwire) -- 08/04/11 -- It has been a banner year already for the biotechnology sector with new chemical and molecular entity approvals reaching a 20-year high. Additionally, FDA officials claim drug applications are being reviewed faster than ever. This is welcome news for early stage drug developers -- many of which have potential blockbuster drugs working their way through the regulatory process. The Bedford Report examines the outlook for companies in the Healthcare Sector and provides equity research on Oncothyreon, Inc. (NASDAQ: ONTY) and Keryx Biopharmaceuticals Inc. (NASDAQ: KERX). Access to the full company reports can be found at:
Citing agency officials, The Wall Street Journal reported this month that the Food and Drug Administration (FDA) has approved 20 new drugs so far this year -- just one short of the total for all of 2010. Some lawmakers in Washington have been arguing that the FDA's tougher safety stance has slowed down the pace of drug approvals and is hurting the pharmaceutical and biotech industry.
Janet Woodcock, the head of the FDA's drug division, defended the FDA's role, saying challenges being faced by the biotech and pharmaceutical industry are related to high failure rates of drugs in the development process rather than FDA regulations.
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Keryx Biopharmaceuticals Inc. said that it does not expect to be required to conduct additional studies of its kidney drug Zerenex to win regulatory approval in Europe. The company said it was informed by a European Union advisory committee that if its current late-stage clinical trial is successful, that study would provide enough data to support a marketing application in the EU.
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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Datum: 04.08.2011 - 06:16 Uhr
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