FDA Policy/General

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Ipsen has completed an acquisition of a portfolio of five international consumer healthcare products from Sanofi: Prontalgine, an analgesic for treating moderate to severe pain; Buscopan, an antispasmodic, Suppositoria Glycerini, a laxative; and Mucothiol and Mucodyne, expectorants for cough and flu.

Horizon Pharma has agreed to acquire River Vision Development Corp. and its development-stage medicine teprotumumab (RV001), a fully human monoclonal antibody (mAb) currently in development for thyroid eye disease, a rare, autoimmune inflammatory disorder. Under the terms of the agreement, Horizon Pharma will acquire all outstanding equity of River Vision for an upfront cash payment of $145 million, plus potential future milestone and earn-out payments.

Bruker says it has acquired Luxendo, a privately held spin-off of the European Molecular Biology Laboratory that develops and manufactures proprietary light-sheet fluorescence microscopy instruments. Luxendo’s proprietary single-plane illumination microscopy technique reportedly reduces sampling times over conventional laser scanning confocal microscopes, while reducing phototoxicity and damaging side effects on living specimens.

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