An international team of researchers has created two bat stem cell lines that reveal an unusual number of viral sequences in bat cells compared with those of other mammals. Writing in an article posted online Feb. 21, 2023, in Cell, the scientists suggested that the unusual amount of viral genetic material found in the bat stem cells could explain why these mammals are largely unaffected by most viral infections, despite being able to transmit them.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alterity, Apellis, Astellas, Chiesi, CSL, Iveric, Karyopharm, Menarini, Merck, Moderna, Specialised, Teva, Travere, Uniqure.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amniotics, Jasper, Merck, Moderna, NS, Orion, Pfizer, Sarepta, Theriva, Valneva.
The emergence of new variants of concern (VOCs) of SARS-CoV-2 may limit the efficacy of monoclonal antibodies and vaccines currently used in the clinic.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Axcella, Entera, Kancera, Nymox, Ose, Pharming, Redhill.
After gaining emergency regulatory approval in Japan for its oral COVID-19 antiviral, 3CL protease inhibitor Xocova (ensitrelvir/S-217622), Shionogi & Co. Ltd. is advancing several global phase III trials across a wide range of COVID-19 patient populations. Branded as Xocova in Japan, ensitrelvir received emergency regulatory approval from Japan’s Ministry of Health, Labour and Welfare in late November 2022 for SARS-CoV-2 infection based on the results from phase II/III trials in non-hospitalized patients in Asia.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Albireo, Athersys, Avidity, Biocon, Healios, Lemonex, Mirum, Neurona, Soligenix, Verve, Viatris.
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