Dendreon Files for Chapter 11 Voluntary Bankruptcy Reorganization – Production Continues

It was announced this morning that Dendreon (the manufactures of Provenge) has filed for voluntary Chapter 11 Bankruptcy. After having spoken with a representative at Dendreon I have learned that the company has been in negotiations with its creditors and agreed to voluntarily file for financial reorganization. The agreement that Dendreon has reached with their [...]

Doctoral Student Develops A Device That Provides An Up-Close Look At Cancer’s Movement In The Body

Sometimes scientific research is amazing! We are so lucky to have so many brilliant and gifted young people interested in conquering cancer. One of these brilliant young people is a doctoral student at Johns Hopkins, Andrew Wong. Mr Wong is a Ph.D. student studying materials science and engineering. Along with his facility advisor he has [...]

Agent Orange Exposure? Your Children & Grandchildren Might Be At Risk!

A large number of the readers of this blog either have had exposure to Agent Orange or have family members who have had the exposure. We know that for those men exposed their risks for developing prostate cancer are greatly increased. Besides an increased risk of developing the cancer there is evidence that Agent Orange [...]

Long-Term Results of COU-AA-302 Show Abiraterone (Zytiga) Has A Survival Benefit

When the FDA approved Abiraterone with prednisone (Zytiga) in the pre-chemotherapy stage they approved it after an interim analysis of data was performed of the phase III clinical trial (COU-AA-302), The analysis was performed by an independent data monitoring committee that found a significant difference in radiographic progression-free survival (scans that showed no tumor progression [...]

Bayer’s efforts to insure safety and restore Xofigo production

Malecare received more detail from Ms. Gissoo Decotis, Deputy Director of Oncology Advocacy Relations Bayer HealthCare, LLC. The following is about Bayer's efforts to insure safety and get Xofigo back into the market. "Following extensive root cause analyses, corrective actions at the manufacturing site were put into place. These actions included isolation of the affected [...]

By |2014-11-04T11:47:17-05:00November 4th, 2014|Advanced Prostate Cancer, Xofigo|0 Comments

Bayer HealthCare Announces the Resumption of the Production of Xofigo (Ra 223 dichloride)

Bayer HealthCare has announced that they have now resumed production of Xofigo (Ra 223 dichloride). Bayer has indicated that an initial lot of Xofigo has already been released so some patients will be able to re-start their treatment as early as this week. Bayer is in the process of contacting treating physicians with the news. [...]

Outcomes Analysis of Pooled Individual Data from Randomized Clinical Trials of Degarelix versus Luteinising Hormone-Releasing Hormone Agonists

Degarelex (Firmagon) (approved by the FDA in December of 2008) is a hormonal therapy drug used to treat advanced prostate cancer that has become metastatic and castrate resistant (mCRPC). Degarelix is a GnRH receptor that binds to the pituitary GnRH receptors, reducing the release of gonadotropins leading to a quick and profound onset that blocks [...]

Good News from Bayer – The Xofigo Problem May Be Resolved & Bayer Hopes that the First Batch Will Be Delivered in November

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, [...]

We Need to Report Serious Adverse Events or Serious Drug Side Effects to the FDA – How You Can Make a Report

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 [...]

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