Category | Drug Development

Somaxon (finally) wins FDA approval for sleep drug Silenor

Posted on 19 March 2010

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 rattles analysts with long delay for Alzheimer’s program

Posted on 19 March 2010

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 shelves failed lung cancer program

Posted on 19 March 2010

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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HGS investors shrug off a mid-stage cancer failure

Posted on 18 March 2010

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 Says NSCLC Phase III Trial Met Its Primary Endpoint

Posted on 18 March 2010

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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Novartis reports success with novel blood pressure drug

Posted on 18 March 2010

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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Merck and Portola: Finding a Blood Thinner’s Sweet Spot

Posted on 17 March 2010

“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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MannKind addresses Afrezza concerns following FDA response

Posted on 17 March 2010

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: Tekturna doesn’t help after heart attack

Posted on 17 March 2010

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 inhaled insulin drug Afrezza delayed

Posted on 16 March 2010

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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