Phase III stakes are always high. But for Merck & Co. Inc., results of a late-stage test of its SARS-CoV-2 antiviral, molnupiravir, stand to determine not just the fate of a desired emergency use authorization (EUA), but also a $1.2 billion purchase agreement with the U.S. government pending the EUA. The RNA polymerase inhibitor, invented at Emory University and developed with Ridgeback Biotherapeutics LP, is being evaluated in a phase III study for the treatment of non-hospitalized patients with mild to moderate COVID-19. An earlier study found it unlikely to deliver clinical benefit for hospitalized patients.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Ananda, Asklepios, Avadel, Bluerock, Chinook, Effector, Icosavax, Incarda, India Globalization, Nanology, Nascent, Noveome, Noxxon, Synaptogenix, Virios.
HONG KONG – Singapore authorities have given provisional approval for a locally developed breath test for COVID-19. The test is developed by Breathonix Pte Ltd., a spin-off company from the National University of Singapore through its Graduate Research Innovation Program. The company said its Brefence Go COVID-19 breath test system was the first test of its kind to secure provisional authorization in Singapore.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Alpha Tau Medical, Angiodynamics, Elute, Eyeyon Medical, Glaukos, Mimedx, Roche.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbive, Alessa, Amicus, Amryt, Ascletis, Bavarian Nordic, Bergenbio, Bluebird, Cantargia, Crestone, Cullinan, Iaso, Incyte, Kiniksa, Liminal, Moderna, Neoimmunetech, Novo Nordisk, Spinogenix Takeda, VBI.
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