Biologics

Fast Track for Glioblastoma Vaccine

FDA has granted MimiVax a fast track designation for its SurVaxM vaccine that is being studied for treating newly diagnosed glioblastoma (nGBM). The designation was based on data from the company’s Phase 2a Study of SurVaxM for nGBM that found 51% of patients receiving SurVaxM survived at least two years and 41% survived at least three years. “The median overall survival of 25.9 months with nGBM in this study is considerably higher than would be expected with standard therapy alone,” the company says.

SurVaxM is described as a first-in-class, patented peptide mimic immunogen that “targets survivin, a cell-survival protein present in 95% of glioblastomas and in many other cancers.” It works by stimulating a patient’s own immune response in an effort to control tumor growth and prevent disease recurrence, MimiVax says.

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