Today, Bayer supplied Malecare with an update about the status of the Xofigo shortage. Bayer has told us that they have identified the cause of the problem and have implemented a system to resolve the problem. They are hopeful that the first batch of drug will able to be released in the month of November, [...]
The Food and Drug Administration (FDA) is charged with protecting the general health and well being of Americans with medicines and certain treatment equipment. Sometimes these medications or treatment equipment fail, don't work as indicated or cause serious, life threatening side effects. Reporting these events is important so the FDA can track and monitor these [...]
Some good news for my European brothers, the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has adapted a positive opinion in support of the label expansion of enzalutamide (XTANDI) to include the treatment of men with metastatic castrate resistant prostate cancer (MCRPC) who are asymptomatic or mildly symptomatic after the failure [...]
In a poster presentation at the recent European Society of Medical Oncologists (ESMO) there was a very interesting poster presented updating a phase 3 clinical trial (CA184-043) which evaluated the overall survival (OS) with radiotherapy (RT) followed by either the immunologic drug Ipilimumab (Ipi) or with a placebo. This trial did not meet its endpoint [...]
Its day 20 since Xofigo production stopped. How are you? Please email Joel at joel@malecare.org about how the Xofigo shutdown has affected your life. Bayer has issued a public statement about the shortage of Xofigo (radium Ra 223 dichloride). After reviewing their statement I find that there is no new information that we haven’t already [...]