Finally, on Monday, Dendreon announced that it completed its Food and Drug Administration (FDA) application for the approval of Provenge (sipuleucel-T). Provenge is designed as a vaccine that stimulates the body's own immune system to fight prostate cancer. It is a different type of vaccine from what most of us knows as it is given [...]
OncoGenex Pharmaceuticals, Inc. (OGXI) announced that it's experimental product, OGX-011, also known as custirsen sodium, received fast track designation from the U.S. Food & Drug Administration (FDA) for the treatment of progressive metastatic prostate cancer in combination with first-line docetaxel treatment (chemotherapy). OGXI had previously received this same designation for second-line docetaxel treatment with OGX-011 [...]
I am truly saddened by the passing of Senator Edward Kennedy, a giant in the area of advocacy for people with cancer and for health care policy. Senator Kennedy’s concerns always included not only his home state of Massachusetts, but all Americans no matter from what state they lived. Senator Kennedy, as a passionate anti-cancer [...]
There is some good news on the horizon, or at least we are setting up for the possibility of some future good news. Coming off of the recent news about the very successful phase II trial of CB7630 (abiraterone acetate), Cougar Biotechnology, Inc. has reached agreement with the FDA under a special protocol assessment (SPA) [...]
The FDA did introduce its Critical Path initiative in 2004. But, even these expedited processes have become bogged down. The FDA has responded to the political winds and become cautious after the negative publicity it received from the withdrawals of drugs like Rezulin and Vioxx. The best and most recent delay in the prostate cancer [...]
An article in today's New York Times about obtaining drugs under the compassionate use clause boiled my blood. I am not usually one without words, but this story has left me speechless, or wordless. I can not add anything to the story, it speaks for itself and makes me cry. Joel T Nowak MA, MSW
Last Friday's post included information about the recent appointment of Dr. Frank M. Torti as the Acting Director of the FDA. Dr. Torti has invited public comments about the future direction of the FDA. As a representative of Malecare, I have provided specific feedback to Dr. Torti. The following post includes my comments to him. [...]
Dr. Frank M. Torti, M.D., MPH has just been appointed as the Acting Commissioner of Food and Drugs (FDA). He has been a prominent clinician, scientist and researcher in molecular oncology. Until his appointment at the FDA as Principal Deputy Commissioner and first Chief Scientist in April 2008, Dr. Torti had served the as Charles [...]
The Food and Drug Administration (FDA) is one of the major governmental entities that has a significant, direct and immediate affect on any of us who has any illness. All men with prostate cancer have had their life and their deaths impacted by the FDA. This impact has not been on just a few of [...]
GTx announced in a company media release that it has requested that the FDA consider its new drug application (NDA) for the use of toremifene 80 mg to prevent bone fractures in men with prostate cancer receiving androgen deprivation therapy (ADT). GTx has asked for a priority review of its application stating that “there are [...]
