SOURCE: The Bedford Report

The Bedford Report

November 02, 2011 08:16 ET

Faster FDA Review Process Bodes Well for NPS Pharmaceuticals and Cel-Sci Corp

The Bedford Report Provides Equity Research on NPS Pharmaceuticals & Cel-Sci Corporation

NEW YORK, NY--(Marketwire - Nov 2, 2011) - 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 NPS Pharmaceuticals, Inc. (NASDAQ: NPSP) and Cel-Sci Corporation (NYSE Amex: CVM). Access to the full company reports can be found at:

Some lawmakers in Washington have been arguing that the FDA's tougher safety stance has slowed down the pace of drug approvals and hurts the pharmaceutical and biotech industry. According to Krishan Maggon, a Geneva-based pharmaceuticals consultant, the number of new biotech drugs approved in the U.S. has remained in the 20 to 25 range during the past four years, while in Europe the figure was a record-low 14 last year.

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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CEL-SCI is dedicated to research and development directed at improving the treatment of cancer and other diseases by utilizing the immune system, the body's natural defense system. 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.

NPS Pharmaceuticals is an outsourcing-based development company focused on bringing biopharmaceuticals to patients with rare disorders and few, if any, therapeutic options. Earlier this week shares of the company plummeted after it reported mixed Phase III clinical data for its gastrointestinal treatment Gattex in the treatment of a rare condition known as short bowel syndrome. NPS said that while Gattex was able to help many of the patients reduce their dependence on intravenously-administered fluids and food, three cases of cancer were also reported among the study group.

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