SOURCE: The Bedford Report

The Bedford Report

November 02, 2011 08:16 ET

Faster FDA Drug Reviews Should Benefit Cardium Therapeutics and CytRx Corporation

The Bedford Report Provides Equity Research on Cardium Therapeutics & CytRx 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 Cardium Therapeutics (NYSE Amex: CXM) and CytRx Corporation (NASDAQ: CYTR). 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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CytRx Corporation is a biopharmaceutical research and development oncology company engaged in the development of high-value human therapeutics. The CytRx oncology pipeline includes three programs in clinical development for cancer indications: INNO-206, tamibarotene and bafetinib. In June 2011, CytRx announced that preliminary results from its ENABLE Phase 2 trial demonstrated that bafetinib was clinically active in a group of patients with B-CLL who have failed several other treatments for their cancer.

Cardium Therapeutics, Inc. is a development-stage company. Cardium's business is focused on the acquisition and strategic development of product opportunities or businesses having the potential to address unmet medical needs. Shares of the company skyrocketed last month after it said it received marketing approval from the U.S. Food and Drug Administration to sell Excellagen, its flagship product for diabetic foot ulcers and other skin wounds.

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