Just over a month after scoring U.S. FDA clearance for dry eye disease therapy Miebo (perfluorohexyloctane), Bausch + Lomb Corp. is adding Xiidra (lifitegrast) to its arsenal in the same indication as part of the potential $2.5 billion deal with Novartis AG, which is divesting its “front-of-eye” ophthalmology assets.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arup Laboratories, Feops, USMI.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Advanced Health, B. Braun, Imagion Biosystems, Microbot, Nanalysis Scientific, Navidea, Pavmed, Pocdoc, Prophase, Rockwell Medical, Siemens Healthineers.
The U.S. Office of Inspector General (OIG) reported June 28 that it had launched a series of enforcement actions against perpetrators of a variety of forms of health care fraud, including in the areas of telemedicine and opioid abuse. The 78 individuals arraigned in this crackdown are said to be responsible for $2.5 billion.
The U.K. Competition and Markets Authority (CMA) has declared its opposition to a proposed merger between Cochlear Ltd. And Oticon Medical A/S, two of the prime movers in the bone conduction implant space.
University of Chicago spinoff Flow Medical Inc. is finalizing its design of a multi-function catheter to diagnose and treat venous thromboembolic disease – boosted by a $1 million private investment to commercialize the device.
The European Society of Hypertension (ESH) has recommended that renal denervation (RDN) be offered as an adjunctive therapy to patients with resistant hypertension. Releasing new and updated guidelines on the management of arterial hypertension, the ESH said recent randomized controlled trials showed that endovascular RDN can be associated with a significant, albeit not marked, office and ambulatory blood pressure reduction in patients with uncontrolled hypertension.
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