DUBLIN – The most solid conclusion that can be drawn from Immunic Inc.’s phase II trial of IMU-838 in hospitalized COVID-19 patients is that a reduction in the need for invasive ventilation is no longer a useful endpoint for studies of COVID-19 drugs.
PERTH, Australia – With the first COVID-19 vaccine ready to be launched in Australia, the Therapeutic Goods Administration has released guidance on its pharmacovigilance plan to track real-world safety data and adverse events following immunization.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Altimmune, Amgen, Beigene, Coherus, JCR, Johnson & Johnson, Novartis, RDIF, Ultragenyx, Verrica.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Algernon, Asklepios, Astrazeneca, Biophytis, Cidara, Eli Lilly, Evgen, Immunic, Inhibikase, Kintara, Mesoblast, Mind Medicine, Moebius, Pfizer, PTC, Redhill, Salarius, Scisparc, Selecta, Silence.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has granted provisional approval to Astrazeneca Pty Ltd. for its COVID-19 vaccine, a recombinant adenovirus vaccine, making it the second COVID-19 vaccine to receive regulatory approval in Australia, following the Jan. 26 provisional approval for Pfizer Australia Pty Ltd.’s COVID-19 vaccine, branded Comirnaty.
HONG KONG – A Japanese phase III study of Chugai Pharmaceutical Co. Ltd.’s interleukin-6 inhibitor Actemra (tocilizumab) in patients hospitalized with severe COVID-19 pneumonia has read out, expanding what’s known about the drug’s use in the pandemic, which had been inconclusive until recently, though is now known to reduce mortality in the vulnerable population.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Axonics, Electrocore, Front Line Medical Technologies, Insightec, Luminostics, Saladax, Shockwave Medical, Smart Medical.
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