FDA Policy/General

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Gilead Sciences and its cell-therapy subsidiary Kite Pharma have agreed to acquire Cell Design Labs, a pre-clinical stage biotherapeutics company specializing in custom cell engineering. Under the terms of the agreement, Gilead will acquire all outstanding shares of Cell Design for about $567 million. The transaction will build on Gilead’s recent acquisition of Kite in August, and has the potential to help accelerate the development of next-generation cellular therapy candidates.

Veru Inc. has acquired world-wide rights to a novel, proprietary oral granule formulation for solifenacin from Camargo Pharmaceuticals Services. Solifenacin is the active ingredient in Astellas Pharma’s VESIcare for treating overactive bladder in men and women. The formulation would address patients difficulty swallowing tablets. FDA recently confirmed in a meeting with Veru that regulatory approval for the solifenacin formulation will require a single bioequivalence study and that no additional nonclinical, clinical efficacy or safety studies will be required.

Edwards Lifesciences has exercised an option to acquire Harpoon Medical for $100 million. Harpoon is developing a device designed to create a less invasive form of open heart surgery that repairs the valve flowing from the left atrium to the left ventricle. It also could cut time of procedures to less than 60 minutes from the current time of three to six hours. The device allows surgeons to enter through a small opening between the ribs and repair the mitral valve while the heart continues to beat.

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