SOURCE: Paragon Financial Limited
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 Paragon Report examines investing opportunities in the Biotechnology Industry and provides equity research on Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) and Vivus, Inc. (NASDAQ: VVUS). 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 hurting 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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The FDA has been extremely hesitant towards obesity drug approvals due to both safety and efficiency concerns. Due to the overwhelming percentage of overweight Americans, an effective and safe weight loss drug is seen to have astronomical earnings potential.
Last month Vivus resubmitted a new drug application for its Qnexa obesity drug, aiming once more for the approval of the drug from the Food and Drug Administration. The FDA rejected Qnexa last year, asking for more information about the potential risk that one of Qnexa's active ingredients, topiramate, could cause birth defects in babies born to women who take the drug.
Arena's obesity drug, Lorcaserin, was rejected in late 2010 after a memo from the FDA stated that the drug did not satisfy the mean efficacy requirements that the FDA has laid down for obesity therapies, and additionally caused tumors in rats. Arena plans to re-file its application by the end of 2011 -- meaning the drug would likely not be available until 2012 at the earliest.
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