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Tag Archives: FDA

60 Minutes, the poliovirus, and Breakthrough Therapy Designation

Since the news program “60 Minutes” first aired two segments in March 2015 focused on an early-phase clinical trial taking place at Duke University, a lot of excitement has been generated about the investigational treatment highlighted: PVS-RIPO – more commonly referred to as the re-engineered poliovirus. The excitement was well-warranted, as the results reported at […]

Moving The Field Toward More Patient-Focused Drug Development

Together with our partners in the Jumpstarting Brain Tumor Drug Development Coalition – Accelerate Brain Cancer Cure (ABC2), Musella Foundation for Brain Tumor Research and Education, and the Society for Neuro-Oncology – NBTS has been advocating for the brain tumor research field to take patients’ quality of life into great account during clinical trials. As […]

So You Heard About Rintega? Here’s What’s Next for Brain Tumor Drug Development

Last week, news broke that a promising clinical trial of a new type of treatment for a subset of glioblastoma (GBM) patients – an immunotherapeutic vaccine made by Celldex Therapeutics called RINTEGA (rindopepimut) – was discontinued because patients receiving the investigational therapy were not doing better than patients in the control arm. As we said in our statement regarding […]

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