Loyal Arena investors battling for diet drug approval
Read more: Loyal Arena investors battling for diet drug approval - FierceBiotech http://www.fiercebiotech.com/story/loyal-arena-investors-battling-diet-drug-approval/2010-10-14
Read more: Loyal Arena investors battling for diet drug approval - FierceBiotech http://www.fiercebiotech.com/story/loyal-arena-investors-battling-diet-drug-approval/2010-10-14
Excerpt
Can FDA regulators be influenced by a grassroots campaign pushing for an approval of a controversial new therapy? A group of Arena Pharmaceuticals' investors are determined to find out as they gather signatures for a petition and mount a letter-writing campaign lambasting the negative vote handed down by an FDA advisory panel charged with reviewing the data for the obesity drug Lorcaserin.
FDA staffers recently stunned a small crowd of analysts who track Arena by publicly unveiling preclinical signs of tumors in rats injected with the therapy. With the bar on safety raised to a very high level for obesity drugs, and a history of problems with side effects that has torpedoed a string of such therapies, a majority of panelists were concerned enough to vote against an approval. And as Forbes' Matthew Herper recently reported, a 'no' vote by an FDA panel is only rarely overlooked by the agency when it makes a final decision.
FDA staffers recently stunned a small crowd of analysts who track Arena by publicly unveiling preclinical signs of tumors in rats injected with the therapy. With the bar on safety raised to a very high level for obesity drugs, and a history of problems with side effects that has torpedoed a string of such therapies, a majority of panelists were concerned enough to vote against an approval. And as Forbes' Matthew Herper recently reported, a 'no' vote by an FDA panel is only rarely overlooked by the agency when it makes a final decision.
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