Drugs

Ziopharm Reports ‘Unrelated’ Death in Gene Therapy Trial

Ziopharm Oncology says a patient has died in an ongoing multicenter Phase 1 study involving gene therapy candidate Ad-RTS-hIL-12 plus orally administered veledimex in recurrent or progressive glioblastoma or grade 3 malignant glioma. “The patient death resulting from intracranial hemorrhage in the third cohort of this Phase 1 study was deemed unrelated to study drug following the receipt and analysis of additional information by the sponsor and the study’s safety review committee,” it says. The study remains open for enrollment, and Ziopharm says it will provide further updates on the progress of the study, including longer-term survival follow up, at an appropriate meeting later this year.

“Preliminary overall survival in this study, including a median follow-up of over eight months in the first dose cohort, remain encouraging, and we will continue to work diligently toward understanding the full potential of Ad-RTS-hIL-12 plus veledimex in this disease, with the goal of providing safe and effective treatment options to these patients,” Ziopharm says. Glioblastoma is an aggressive primary brain tumor affecting approximately 74,000 people worldwide each year. Recurrent glioblastoma is an aggressive cancer with one of the lowest three-year survival rates (3%), among all cancers.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome