Placebo effect undermines crucial clinical trial for LibiGel

The power of suggestion and anticipation can be just as potent as a drug it seems, especially when it comes to sex. Or at least that’s one of the conclusions that could be reached in the aftermath of phase 3 clinical trials testing the efficacy of LibiGel, which is designed to treat sexual dysfunction in [...]

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Phase 3 clinical trials for sex dysfunction gel fall short

A gel developed by Antares (AMEX:AIS) and licensed to BioSante Pharmaceuticals (NASDAQ:BPAX) to treat female sexual dysfunction failed two phase 3 clinical trials testing efficacy, according to a statement from BioSante.Initial analysis of the data from the trials showed that the tests “did not meet the co-primary or secondary endpoints,” the statement said. LibiGel is [...]

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Morning Read: FDA to consider pulling Avandia

Highlights of the important and the interesting from the world of healthcare:FDA panel to consider pulling Avandia. An expert panel of the U.S. Food and Drug Administration is planning a mid-July meeting to consider whether GlaxoSmithKline’s (NYSE: GSK) diabetes drug Avandia should be pulled from the market. Dr. Steven Nissen of the Cleveland Clinic [...]

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BioSante’s shares jump on positive results for cancer vaccine study

Shares of BioSante Pharmaceuticals rose 10 percent after the company reported positive results from a clinical study of a leukemia vaccine.The Phase 2 trial showed that BioSante’s GVAX vaccine “may be able to reduce or eliminate” the last remaining cancer cells in patients who are suffering from chronic [...]

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BioSante raises $18M to fund continuing trial of sexual dysfunction drug

BioSante Pharmaceuticals Inc. has received funding commitments totaling $18 million from two institutional investors.The company plans to use the proceeds to continue funding a Phase 3 clinical trial of LibiGel, a drug that treats under-active sexual desire in menopausal women. BioSante says it plans to seek approval from the U.S. Food and Drug Administration by [...]

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BioSante closes on $12 million deal to fuel work on LibiGel

BioSante finalized the sale of approximately 6 million shares — with warrants to purchase 2.4 million more shares — to three institutional investors. The cash infusion will fund a Phase III study of LibiGel, which treats low sexual desire in women.

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BioSante acquisition adds cash to complete trials for sexual dysfunction drug

Illinois’ BioSante paid $38 million in stock for Cell Genesys and an ownership stake in a former subsidiary. In exchange, it gains fresh money to get its LibiGel product through Phase III clinical development under a U.S. Food and Drug Administration Special Protocol Assessment.

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