Drugs

FDA Accepts NDA for Tetraphase Pharmaceuticals Antibiotic

FDA has accepted for review a Tetraphase Pharmaceuticals NDA for eravacycline for treating complicated intra-abdominal infections. The user fee review action target date was set for 8/28. The submission includes data from the IGNITE1 and IGNITE 4 Phase 3 clinical trials and showed that twice-daily eravacycline was well tolerated and achieved high clinical cure rates in patients with complicated intra-abdominal infections, the company says. “Both studies demonstrated statistical non-inferiority of eravacycline to two widely used comparators — ertapenem in IGNITE1 and meropenem in IGNITE4 — for the primary efficacy endpoint of clinical response at the test-of-cure visit,” it says.

Eravacycline is a synthetic fluorocycline antibiotic being developed for treating complicated intra-abdominal infections and other serious infections, including those caused by multidrug-resistant pathogens that have been highlighted as urgent public health threats by both the World Health Organization and the U.S. Centers for Disease Control & Prevention.

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