When the U.S. FDA convened its Vaccines and Related Biological Products Advisory Committee (VRBPAC) April 6 to advise on a path forward to the next generation of COVID-19 vaccines and boosters, there was a lot of talk about all the unknowns.
After a difficult start, there’s been more progress in PIK3 drug class, with FDA approval of Novartis AG’s Vijoice (alpelisib) for the rare condition PIK3CA-related overgrowth spectrum (PROS).
The China Securities Regulatory Commission (CSRC) has issued draft rules to permit U.S. auditors to examine U.S.-listed Chinese companies on April 2, 2022, following a provisional list by the U.S. SEC.
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.
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