Drugs

Auris Medical Get FDA Buy-in for Pivotal Trial

FDA has approved Auris Medical’s proposed choice of primary and secondary efficacy endpoints, the safety endpoints, as well as the planned sample size and statistical methodology for a pivotal Phase 3 trial of AM-111 (brimapitide), an investigational treatment for sudden sensorineural hearing loss. In a recent meeting with the agency, the company discussed the results of the HEALOS Phase 3 trial, which showed a clinically meaningful and nominally significant improvement in hearing for the AM-111 0 group compared to placebo in the subpopulation of patients with acute profound hearing loss, the company says.

Auris says AM-111 is being developed in a biocompatible gel formulation for treating sudden sensorineural hearing loss with a single-dose administration into the middle ear. The cell-penetrating peptide is designed to inhibit the JNK stress kinase, which is activated following various types of cochlear stress that cause acute inner ear hearing loss and plays a key role in apoptosis of sensory cells as well as in inflammatory responses, 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