Tag Archives: Clinical trial

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

By George Koroneos | Published: August 16, 2010
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 generics firms—the green [...]
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Advisory Panel Rejects Avastin For Breast Cancer Treatment

By George Koroneos | Published: July 21, 2010
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 with [...]
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Avandia on Trial

By Walter Armstrong | Published: July 12, 2010
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

By George Koroneos | Published: June 16, 2010
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 get [...]
Posted in Regulatory, Strategy | Also tagged , , , , , | 1 Comment

Avastin Study Shows Promising Data for Cancer Patients

By George Koroneos | Published: June 8, 2010
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 Society [...]
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