Drugs

U.P. Oncolytics Gets Orphan Status for Glioma Therapy

FDA has granted U.P. Oncolytics an orphan drug designation for its oncolytic virus-based therapy to treat malignant gliomas. Last month, the company was awarded a $500,000 from NIH as part of a Phase 1-2 fast-track grant that will fund the company’s proposed in vitro and in vivo IND-enabling studies on the “validation of a novel treatment for glioblastoma using oncolytic Zika virus.”

The company says about a quarter of the 80,000 newly diagnosed primary brain tumors each year in the U.S. are gliomas. These form when glial cells grow out of control in the brain and spinal cord. “Glioblastoma Multiforme (GBM), the most malignant and pervasive subtype of glioma and the most common primary brain tumor in adults, is included within the scope of the orphan designation by the FDA,” it 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