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Varian Medical Systems announced it has received 510(k) clearance from the US Food and Drug Administration (FDA) to market the Nexus DR, a high resolution imaging system for X-ray imaging using a digital X-ray detector. The Nexus DR is designed to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications. The system is a single common imaging platform intended for general radiographic procedures (excluding fluoroscopy, angiography, and mammography).
Aralez Pharmaceuticals Inc., a global specialty pharmaceutical company, announced that the US Food and Drug Administration (FDA) has approved once-daily Yosprala, the only prescription fixed-dose combination of aspirin, an anti-platelet agent, and omeprazole, a proton pump inhibitor (PPI) in the US. Yosprala is indicated for patients who require aspirin for secondary prevention of cardiovascular (CV) and cerebrovascular events and who are at risk of developing aspirin associated gastric ulcers. The company is expanding its US sales force by 85 representatives in September to a total of 110 high quality sales representatives and plans to begin the US promotional launch of Yosprala the first week in October.
Sanofi announced that it filed a patent infringement suit against Merck Sharp & Dohme Corp. (“Merck”) on September 16, 2016 in the United States District Court for the District of Delaware. In its suit Sanofi alleges infringement of ten patents.
Neurocrine Biosciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has conditionally accepted the proprietary name "INGREZZA™" for the Company's once-daily vesicular monoamine transporter 2 (VMAT2) inhibitor valbenazine.
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