The U.S. FDA has given the green light to a pelvic organ prolapse (POP) repair device developed by Misgav, Israel-based Escala Medical Ltd. The mesh-free, non-surgical repair system is designed to anchor sutures to ligaments of the pelvic floor in an incision-free procedure. Escala, which is a portfolio company of Israeli government franchised incubator Trendlines Group Ltd., believes the device will help the 1 in 5 women in the U.S. affected by POP.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aidoc, Arterys, Escala, Seegene.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascletis, Beigene, Bionecure, Bioxcel, Dialectic, GSK, Innovent, Iovance, Merck, Novartis, Sellas, Tonix, UCB, Vir.
The spike in U.S.-based telehealth visits during the COVID-19 pandemic was greeted with cheers among advocates of the technology, but the Government Accountability Office (GAO) has advised the Centers for Medicare & Medicaid Services (CMS) to take a closer look at the benefits of telehealth for Medicaid beneficiaries.
The FDA has updated its recommendations for the use of duodenoscopes, which have been at the center of ongoing concerns regarding sterility for several years. The agency is again recommending that U.S.-based facilities use duodenoscopes with disposable parts or fully disposable duodenoscopes, but facilities that want to comply with those recommendations will face a much higher cost of use, according to several sources of cost data.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Moleculight, Paige.
Glaxosmithkline plc and Vir Biotechnology Inc.’s sotrovimab has become the latest COVID-19 antibody to be pulled from the market in the U.S., after the FDA revoked its emergency use authorization (EUA) because of the rise of the omicron BA.2 subvariant.
Medicine shortages have been of particular concern during the COVID-19 pandemic, and Australia’s Therapeutic Goods Administration said it would seek to amend regulations to allow imports of overseas substitute drugs if the Australian drug has been discontinued and canceled from the Australian Register of Therapeutic Goods.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amniotics, BMS, CNS, Starton, Tiziana.
As part of an investigation into the international provisions of the U.S. 2017 tax law, Sen. Ron Wyden (D-Ore.) is zeroing in on how Merck & Co. Inc. was able to report 14% of its pre-tax income in the U.S. when nearly half of its global sales were in the country.
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