Drugs

Symbiomix Agreement with FDA on Secnidazole NDA

Symbiomix says it had a successful pre-NDA meeting with FDA and has reached agreement with the agency on all aspects for an NDA filing in the fourth quarter of 2016 for its SYM-1219 (secnidazole) for treating bacterial vaginosis. The drug is described as a next-generation, 5-nitroimidazole antibiotic expected to be the first single-dose oral treatment approved for bacterial vaginosis. It has been designated by the agency as a Qualified Infectious Disease Product, making it eligible for priority review and at least 10 years of marketing exclusivity.

The company says that a Phase 3 trial comparing a single dose of SYM-1219 to placebo in 189 women who were both infrequent sufferers and patients with recurrent bacterial vaginosis achieved statistically and clinically significant results across all primary and secondary endpoints.

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