FDA Policy/General

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Quest Diagnostics has completed its acquisition of Cleveland HeartLab, which allows Quest to establish a national center of excellence focused on heart disease diagnostics within Cleveland HeartLab's existing 25,000 square-foot clinical laboratory facility in Cleveland. In connection with the acquisition, Quest and Cleveland Clinic have finalized a strategic collaboration intended to speed the commercialization of emerging innovations at Cleveland Clinic, including its Lerner Research Institute. The two entities also intend to collaborate on trials to demonstrate the clinical and economic value of biomarkers.

CryoLife has completed its acquisition of Jotec AG, a German-based developer of endovascular stent grafts and cardiac/vascular surgical grafts. CryoLife manufactures, processes and distributes medical devices and implantable living tissues used in cardiac and vascular surgical procedures.

Astellas Pharma has acquired Cambridge, MA-based Mitobridge for $390 million. The acquisition option was part of a 2013 partnership to discover and develop drugs that target mitochondrial function. The most advanced program is MA-0211, which is presently in Phase 1 clinical trials for Duchenne muscular dystrophy.

The Medicines Company is selling its infectious disease business unit to Melinta Therapeutics. Under the terms of the deal, Melinta is paying $165 million in cash up front, and $55 million worth of Melinta common stock. Another $25 million in cash will be paid 12 months after closing, and another $25 million in cash at 18 months after closing. Melinta will also pay royalties on certain 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