FDA Policy/General

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Varian has acquired privately-held Montreal-based Evinance Innovation, Inc., a clinical decision support software company. The acquisition is expected to expand the capabilities of Varian’s 360 Oncology care management platform by integrating clinical workflow, decision support, and adherence tracking based on leading cancer care guidelines.

Merck has agreed to acquire for about $400 million Viralytics, an Australian company focused on oncolytic immunotherapy treatments for a range of cancers. The transaction will give Merck full rights to Cavatak(CVA21), an investigational oncolytic immunotherapy designed to infect and kill cancer cells.

Aesculap, Inc. has acquired the assets of Dextera Surgical, which manufactures and markets proprietary medical devices for surgical procedures, including surgical staplers and devices for coronary artery bypass graft surgery. Aesculap will oversee operations in Redwood City, CA to continue the manufacturing and distribution of Dextera’s products.

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