Drugs

FDA Accepts Sybiomix NDA for Antibiotic

FDA has accepted for review a Symbiomix NDA for its lead investigational product candidate Solosec (secnidazole oral granules), an antibiotic designed to treat bacterial vaginosis (BV). The agency has granted a six-month priority-review designation with a user fee review target date of 9/17.

The company described Solosec as a potent, next-generation, investigational 5-nitroimidazole antibiotic with enhanced pharmacokinetic properties. FDA previously designated Solosec as a Qualified Infectious Disease Product for treating BV and granted it a fast track designation, which made Solosec eligible for at least 10 years of market exclusivity, Symbiomix says.

The NDA was supported by two pivotal trials in BV (SYM-1219-201 and SYM-1219-301), results from which were presented at the Infectious Diseases Society for Obstetrics and Gynecology annual meetings in 2015 and 2016, respectively. “In clinical trials Solosec demonstrated efficacy for the treatment of BV with only a single, oral, two-gram dose, with excellent safety, tolerability and adherence,” 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