The EMA issued a positive scientific opinion on Glaxosmithkline plc (GSK) and Vir Biotechnology Inc.’s sotrovimab for early COVID-19 treatment. The Committee for Human Medicinal Products (CHMP)’s opinion concerns the monoclonal antibody’s use for adolescents ages 12 and older weighing at least 40 kg (88 pounds), plus adults. All must risk progressing to severe COVID-19 and not require oxygen supplementation.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Albireo, Alexion, Almirall, Astrazeneca, Athenex, Bayer, Bluebird, BMS, Eli Lilly, Genmab, Glaxosmithkline, Janssen, Larimar, Moderna, Myovant Sciences, Rhythm, Takeda, Vir.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biogen, Bostongene, Ginkgo, Kiromic, Nektar, Promis, Recce, Selexis, Therapeutic Solutions.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acupath Laboratories, Advanced Human Imaging, Carestream Health, Caris Life Sciences, Essenlix, Haliodx, Hewlett Packard Enterprise, Labcorp, Max Pharma, Micron Medical, Recuro Health, Roche, Supdoc, Test Today USA, Xphyto.
As infections and deaths continue to surge in some countries so does the demand for unfettered access to the technologies behind COVID-19 vaccines and other medical products. In seeking that access, several countries are stressing the need to develop their own manufacturing capacity as they look beyond the current pandemic.
Where Ilaris (canakinumab) failed, can Kineret (anakinra) succeed? Swedish Orphan Biovitrum AB is reporting that an investigator-initiated phase III study of its interleukin-1 (IL-1) blocker, Kineret, in 594 hospitalized COVID-19 patients with moderate or severe pneumonia, who had a poor prognosis, uncovered what appear to be dramatic benefits.
LONDON – The U.K. is launching a trial to investigate the potential use of seven different COVID-19 vaccines as boosters, to provide safety and immunogenicity data for if/when immune responses to initial vaccination wane and a revaccination campaign is needed later in the year. The trial, at 18 sites across the country, will recruit 2,886 participants who previously received two doses of either Astrazeneca plc or Pfizer Inc./Biontech SE’s COVID-19 vaccines.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anixa, Everest, Gamadelta, Kintor, Mindmed, Newron, Omeros, Propella, RDIF, Sorrento, Tenaya.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Altavant , Arecor, Biontech, Biopharmics, Codagenix, Eli Lilly, Eurocine, Immunome, Immunoprecise, Lundbeck, Optibrium, Pfizer, Univercells, Verantos, Y-Mabs.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acelrx, Annovis, Astellas, Black Diamond, Cantargia, Crescendo, Laurent, Merck, Obseva, Pyramid, Recardio, Seagen, Sensei, Transcenta, Xalud.
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