On March 10th (my birthday) Dendreon announced that it has obtained clearance of its new work stations from the FDA. The result of this clearance is the quadrupling the output from the New Jersey factory where it makes sipuleucel-T (Provenge). When Dendreon obtained FDA clearance in April of 2010, it had extremely limited manufacturing capabilities [...]
There has been some movement in the House of Representatives pertaining to the issue of future funding for the Department of Defense Prostate Cancer Research Program (DoD). The budget debate continues to slog on. We still could see an eventual governmental shut down if the members of congress are still unable to either pass a [...]
Carboplatin is a chemotherapy agent used for treatment of many types of cancer. Currently, it is approved by the Food & Drug Administration (FDA) for treating patients with ovarian and non-small cell lung cancer. However, some oncologists use carboplatin “off-label” for other cancers. Commonly, these “off-label” uses include testicular, stomach, and bladder cancers as well [...]
The Centers for Medicare and Medicaid Services (CME) decided to review their policies pertaining to paying for Provenge, which costs $93,000 per man. Since the hearings which were held a number of months ago, we have not heard any feedback. Despite this, most of the regions have been paying for the treatment, however there have [...]
It was announced today that the first patient in the TERRAIN study received their first dose in the Phase 2 trial of the investigational drug MDV3100 . MDV3100 is a triple-acting oral androgen receptor antagonist that I have writing about as a drug “On The Horizon”. Triple-acting means that it blocks testosterone binding to the [...]