As you know, on September 16, 2010, FDA held a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (Advisory Committee) to discuss the safety and efficacy of lorcaserin, a drug developed by Arena Pharmaceuticals, Inc. (Arena) to treat obesity.
Last week, the U.S. Food and Drug Administration held a two-day panel of experts on the safety and efficacy of drug-coated stents, tiny devices used in a nonsurgical alternative to heart bypass operations.
And while it previously appeared the companies had pulled TV ads for Vytorin mainly because of the study, Dingell and Stupak, both Michigan Democrats, released a letter warning Merck and Schering they would have to make new, prominent claims about Vytorin's lack of efficacy over a cheaper generic drug, Zocor.
Due to the lack of evidence of efficacy in early clinical trials, the drug (a combination of two proven cardiac medicines) had been rejected by the Food and Drug Administration nine years previously for approval for patients of all races.
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Even a drug that modestly adds to the efficacy of existing cholesterol drugs can be a big seller.
Another reason the public may have gotten a skewed view of antidepressant efficacy is that drug companies have tended to publicize only their most positive studies.
That leaves doctors who want more proof of the drug's efficacy to wait for a study in patients with kidney disease.
CombinatoRx of Cambridge, Mass. just laid off 65% of its 180 employees after a promising arthritis drug fell short of its main goal in a trial, despite some signs of efficacy.
CombinatoRx of Cambridge, Massachusetts just laid off 65% of its 180 employees after a promising arthritis drug fell short of its main goal in a trial, despite some signs of efficacy.
There are no major new safety concerns, but the limited efficacy of the drug gives little reason for panel members to take a risk.
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Because of the potential for unknown side effects, "it is untenable to recommend a drug or nutraceutical in the absence of efficacy evidence simply because it could possibly help and initially appears harmless, " Lon S. Schneider, M.
This month Vertex plans to present initial efficacy results for a drug it believes will avoid the toxicity problems of Boehringer's compound.
Scangos says companies should start looking for genetic variations that predict a drug's efficacy in the very early stages of clinical testing.
The success of a new drug depends upon many things beyond basic safety and efficacy.
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South African politicians insist that they are worried about the long-term cost and efficacy of such drugs, and fret that western drug makers may use the country as a testing ground for markets elsewhere.
The FDA has long considered that even minor changes in the production of biological drugs--including exactly the same isolation and purification procedures applied at significantly larger scale than previously--yield a distinct and new drug that must undergo an independent demonstration of safety and efficacy.
John Tsai, the worldwide team leader for Lipitor, argues that Lipitor's efficacy may save insurers cost in the long run, and that his drug clearly provides a benefit over standard of care.
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