San Diego-based Somaxon has won FDA approval of its sleep drug Silenor, completing a long and financially exhausting quest that has consumed more than $170 million. The third time proved the charm for Somaxon, which had tried and failed twice before to gain an approval, only to be frustrated by repeated questions about the drug’s sustained subjective [...]

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J&J has rattled analysts with a new timeline for the Alzheimer’s drug bapineuzumab, saying that full, late-stage results for the closely-watched therapy may not be available for two years.
“We are conducting some of the largest-scale trials ever in Alzheimer’s disease,” a J&J spokesperson told Bloomberg an e-mailed comment. “When they are complete, we expect to [...]

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Novelos Therapeutics is opting to dump a lead program for non-small cell lung cancer. The Newton, MA-based developer confirmed that NOV-002 had failed both primary and secondary endpoints for NSCLC in a pivotal trial, which is forcing the company to discontinue development of the therapy for that indication. But the CEO tried his best to [...]

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Human Genome Sciences announced this morning that its cancer antibody flunked a mid-stage clinical trial, failing to produce better data on either disease response or progression-free survival for lung cancer when compared to a control group.
Mapatumumab is designed to trigger apoptosis, or cancer cell death, a popular strategy in the cancer field. The antibody binds to [...]

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Abraxis BioScience reports that a Phase III trial showed that Abraxane improved overall response rate in the first-line treatment of patients with advanced non-small-cell lung cancer (NSCLC). The firm says that the FDA previously agreed that this would be sufficient to submit an sNDA for the drug in first-line NSCLC. Abraxis’ stock jumped 33% during [...]

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An experimental hypertension therapy in Novartis’ pipeline has cleared an important mid-stage clinical trial hurdle and is headed for a pivotal test. Researchers for the pharma giant say that LCZ696–a combination of the experimental AHU377 with the standard drug Diovan– significantly better than Diovan alone. And the combo therapy clearly outperformed a placebo.
LCZ696 is a [...]

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“In evaluating an anticoagulant,” says heart researcher Michael Ezekowitz, “it’s all about getting the dose right.”
That’s the next big challenge for Merck and its partner Portola as they prepare to advance the closely held South San Francisco biotech’s drug betrixaban into a large-scale clinical trial in the burgeoning race to develop a replacement for the [...]

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In an analyst call this morning, MannKind discussed yesterday’s complete response letter from the FDA for Afrezza, the company’s inhaled insulin drug. The part of the response that sent tongues wagging yesterday was the FDA’s request that the company submit available clinical data that support the “clinical utility” of Afrezza. Analysts and investors wondered whether the agency’s wording [...]

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Novartis will not pursue an outcomes trial of its high blood pressure med Tekturna (aliskiren) in combination with standard therapy for heart attack patients after the drug failed to demonstrate a statistically significant benefit in preventing changes in the heart’s shape and worsening of its blood pumping ability, the company said today.
Patients receiving Tekturna in [...]

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MannKind’s much-watched inhaled insulin product Afrezza has received a complete response letter from the FDA. According to a release, the letter requests more information related to several areas of the NDA. The good news for MannKind is that the agency cited no safety concerns, but it did ask for updated safety data related to the drug. Additionally, the [...]

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