Drugs

Diamyd Granted Fast Track for Diabetes

FDA has granted Diamyd Medical a Fast Track designation for Diamyd (rhGAD65/alum) for use in treating Type 1 diabetes in pediatric patients with Stage 1 or Stage 2 Type 1 diabetes carrying the genotype HLA DR3-DQ2. Earlier this year, Diamyd was granted fast track for treating Stage 3 Type 1 diabetes (T1D) carrying the HLA DR3-DQ2 genotype.

Those with Stage 1 T1D have tested positive for two or more diabetes-related autoantibodies but still have normal blood glucose values and no symptoms of the disease, according to the company. Individuals with Stage 2 T1D have progressed to abnormal blood glucose values (dysglycemia) and are usually asymptomatic. “Stage 3 T1D is synonymous with clinically diagnosed Type 1 Diabetes,” it says.

Diamyd is described as an antigen-specific immunomodulatory therapeutic for preserving endogenous insulin production. It is designed to be administered directly into a superficial lymph node in children and young adults with recently diagnosed Type 1 Diabetes. “Injections into a superficial lymph node can be performed in minutes and are intended to optimize the treatment response,” the company 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