Yesterday Dendreon, the producers of Provenge, received word from the FDA that their plant in California had been approved to manufacture Provenge. This afternoon they received a positive response from the Centers for Medicare and Medicaid Services (CMS) that a final National Coverage Decision (NCD) for Provenge has been issued requiring Medicare contractors to cover [...]
Early this evening Dendreon received the nod from the FDA to use their new manufacturing plant in Seal Beach, California. The approval of this plant will allow the company to now service the men with advanced prostate cancer in Hawaii as well as more efficiently service those in Western United States with Provenge. When coupling [...]
Darryl, the Malecare Executive Director, posted an organizational response to yesterday's New York Times Article on the newly approved advanced prostate cancer drugs and their economic impact. I thought that I would share his insightful post with everyone. "We can easily price commodities and drugs to whatever the market will bare, but how do we [...]
Today’s New York Times carried a front page article about the high cost of the new prostate cancer treatments. This article seems to be the talk of the town and the talk (based on the comments that have been entered on-line) has been anything but positive. Unfortunately, many of the comments have made with the [...]
Yesterday, Amgen announced that it had submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to expand its license for XGEVA® (denosumab) to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases. If approved, XGEVA would be the first therapy licensed to prevent or [...]