Drugs

Orphan Drug Status for EnGeneIC Tumor Drug

FDA has granted EnGeneIC an orphan drug designation for its epidermal growth factor receptor-targeted, doxorubicin-loaded EDV nanocells for treating glioblastoma multiforme. The clinical stage biopharmaceutical company says it is focused on developing its proprietary bacterially-derived EDV nanocells as a powerful nanoparticle drug, siRNA, or miRNA delivery platform to directly target and kill tumor cells with minimal toxicity, while simultaneously stimulating the immune system's natural anti-tumor response. The intravenously injected EDV nanocells are designed to “exit the leaky vascular system only found within tumors and attach to cancer cells via a specially designed, targeted bi-specific antibody,” the company says. “Once attached, the nanocell is able to enter the tumor cell and deliver a drug, siRNA, or miRNA payload at high concentrations, intracellularly.” EnGeneIC is currently planning to commence further clinical trials in several cancer indications in Australia and the U.S.

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