FDA Policy/General

Synergy Plans NDA for Irritable Bowel Drug

Synergy Pharmaceuticals says it has decided to continue patient enrollment for its two ongoing Phase 3 clinical trials with plecanatide in irritable bowel syndrome with constipation (IBS-C), despite trial monitoring showing slower enrollment pace combined with an increase in the number of patients not meeting randomization criteria after the screening period. The company says it will update its timing for top-line data in both trials to the fourth quarter of this year and plans to file an NDA for placanatide in IBS-C in the first quarter of 2017.

Synergy has also reached the halfway point in FDA’s review of an NDA it filed 1/29 for placanatide for treating chronic idiopathic constipation; through ongoing dialog with FDA it says it remains optimistic about its potential approval by the PDUFA date of 1/29/17.

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