Drugs

FDA Tells Tetraphase It Needs Another Trial for NDA

FDA has told Tetraphase Pharmaceuticals that it will need positive data from an additional Phase 3 trial for its lead candidate, eravacycline, in order to support an NDA for the antibiotic. The drug has shown potent activity against drug-resistant bacteria, including multidrug-resistant pathogens, the company says.

Based on the feedback, Tetraphase says it plans to conduct a pivotal Phase 3 clinical trial to evaluate the efficacy and safety of twice-daily intravenous eravacycline in patients with complicated intra-abdominal infections. It says the study should begin in the fourth quarter, and top-line results could be available as early as the fourth quarter of 2017. In addition, Tetraphase also plans to conduct a Phase 3 clinical trial evaluating eravacycline’s efficacy and safety in patients with complicated urinary tract infections.

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