FDA Policy/General

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Medeon Biodesign has agreed to sell to Tokyo-based Terumo Corp. its large bore vascular closure system. The transaction includes an up-front payment of $20 million and future milestone payments. The acquired device, a suture-mediated closure device with two braids, is intended to target percutaneous large bore procedures via the common femoral artery. It is designed to achieve rapid and reliable hemostasis at the puncture sites with excellent clinical outcomes, Terumo says.

Boston Scientific has acquired EMcision, Ltd., a privately held company located in the U.K. The acquisition will expand Boston Scientific’s endoscopy portfolio to include the Habib EndoHPB probe, an endoscopic bipolar radiofrequency device used to coagulate tissue in the gastrointestinal tract.

Cipher Pharmaceuticals has acquired the exclusive Canadian rights to right to develop and market Trulance (plecanatide) from Synergy Pharmaceuticals. The once-daily tablet is approved by FDA for treating adults with chronic idiopathic constipation and irritable bowel syndrome with constipation.

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