Tag Archives: Clinical trial

Feds Threaten to Pull ProAmatine for Lack of Postmarket Data (Updated 8/18)

Image via Wikipedia FDA on Monday announced that it was looking to withdraw approval for the low-blood-pressure treatment midodrine hydrochloride because the companies manufacturing the drug failed to provide data from post-approval studies. The kicker: The drug was approved 14 years ago. FDA gave midodrine hydrochloride—branded by Shire as ProAmatine and produced by a half-dozen […]
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Advisory Panel Rejects Avastin For Breast Cancer Treatment

An FDA advisory panel on Tuesday voted 12–1 to discontinue Avastin (bevacizumab) as a treatment for advanced breast cancer due to post-market studies stating that the treatment does not to increase patient lifespan by any significant length of time. This is a huge problem for Roche who purchased the treatment as part of its merger […]
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Avandia on Trial

The mid-July FDA advisory committee meeting to decide the fate of GlaxoSmithKline’s Avandia (rosiglitazone) is widely viewed as a test case of how the agency’s new leadership will address controversial drugs with serious risks but confusing data. A request that GSK yank its diabetes blockbuster—three years after first being associated with an increased risk of […]
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Industry and FDA Brace for Change

While the convention floor of the 46th annual meeting of the Drug Information Association bustled with the usual vendors touting the latest and greatest clinical trial technology, the panels (particularly those that featured FDA members) had a remarkably somber tone. The main refrain was: “Things are going to change and everyone must step up or […]
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Avastin Study Shows Promising Data for Cancer Patients

Genentech released the results of its Phase III Avastin study showing that women that take the ovarian cancer treatment in tandem with chemotherapy had a 39 percent improvement in the likelihood of living longer without the disease worsening than patients being treated with just chemotherapy. The data was released at the annual meeting of American […]
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