Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Betterlife, Day One, Hope, Kineta, Kronos, Lyndra, Merck, Petros, Sol-Gel, Ultragenyx.
Sinocelltech Group Ltd. won market approval from China’s NMPA for SCT-800, a B-domain deleted recombinant human coagulation factor VIII, for the prophylactic treatment of severe hemophilia A in adolescent and adult patients. This marks the first homegrown drug for treating hemophilia A in China.
China’s NMPA gave conditional approval to Henan Sincere Biotech Co. Ltd.’s dual-targeting, oral HIV drug, azvudine, to treat HIV-1-infected adult patients with high viral loads. Azvudine could challenge lamivudine, a drug extensively used for treating HIV infection.
Japan’s Ministry of Health, Labour and Welfare approved the Regen-Cov (casirivimab/imdevimab, also known as Ronapreve) antibody cocktail for the treatment of patients with mild to moderate COVID-19 via intravenous infusion.
While regulators and policymakers across the world are stressing the need for equitable access to COVID-19 vaccines, therapies and devices, their own policies and regulations may be getting in the way of that goal. The World Trade Organization (WTO) released a list of trade-related bottlenecks July 20 that are hindering access to pandemic-related medical products.
The FDA’s July 27 webinar on medical device servicing and remanufacturing lent some clarity to the terms of a recent draft guidance on the subject, but there are several overarching policy concerns. The FDA’s Joshua Silverstein said on the webinar that the agency sees servicing as a type of manufacturing, a view that is contradicted by the Medical Imaging & Technology Alliance, which indicated earlier this year that third-party servicers are probably not subject to the regulations applied to manufacturers.
LONDON – Memed Diagnostics Ltd. has adapted the point-of-care test it developed to distinguish bacterial from viral infections to enable rapid assessment of the severity of COVID-19 infections in patients being admitted to the hospital. The triaging tool, Memed COVID-19 Severity, has received a CE mark in Europe and is ready for commercial rollout. After securing the CE mark, Memed is now pursuing emergency use authorization for the test from FDA.
PERTH, Australia – Australia was one of the first nations to slam its borders shut during the pandemic, praising its efforts in containing COVID-19 infections.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cytrellis, Lifesignals, Luxsonic.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aadi, Abbvie, Alexion, Astrazeneca, Beigene, Beximco, Eledon, Fidia, GSK, Incyte, Inhibikase, Iterum, Kyowa Kirin, Neoimmunetech, Otsuka, Polarityte, Saniona.
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