Drugs

FDA Accepts Synergy sNDA for Trulance

FDA has accepted for review a Synergy Pharmaceuticals supplemental NDA for Trulance (plecanatide) for treating adults with irritable bowel syndrome with constipation. The user fee review target date is 1/24/2018. Trulance is currently approved for treating adults with chronic idiopathic constipation.

The submission is based on data from two randomized, 12-week, double-blind, placebo-controlled Phase 3 studies where Trulance 3mg and 6mg doses met the primary endpoint showing statistical significance in the percentage of patients who were overall responders compared to placebo, according to the company. FDA defines an overall responder as a patient who fulfills both a 30% reduction in worst abdominal pain and an increase of at least one complete spontaneous bowel movement over baseline in the same week for at least 50% of the 12 treatment weeks.

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