Although it’s a latecomer to the COVID-19 pandemic in the U.S., there is a wedge of opportunity for Novavax Inc.’s adjuvanted protein-based vaccine among the 10% of the U.S. adult population that has yet to get a first jab.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cstone, Escend, Gilead, Moderna, Neurophth, Neximmune, Novartis, Omega, Polpharma, Prescient.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Codexis, Endo, GBT, Kalivir, N4, Nanomerics, Noxxon, Oncternal, Pfizer, Quoin, Scholar Rock, Serb, Siga, Soligenix, Voltron.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amryt, Beigene, G1, Lantern, Novavax, Revolo, Sinovac, Summit.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biora, Creative, Cytomx, Genscript, Grunenthal, Halberd, Pasithea, Repertoire, SK, Ultragenyx.
European regulators have added several safety messages to approved COVID-19 vaccines, including a warning that Novavax Inc.’s Nuvaxovid could produce severe allergic reactions.
Now that Novavax Inc. has received an emergency use authorization (EUA) from the U.S. FDA allowing adults to receive the adjuvanted vaccine to ward off severe acute COVID-19, it’s time for the CDC to weigh in. Once its Advisory Committee on Immunization Practices meets July 19 to discuss the vaccine and make a policy recommendation, the vaccine will be available on the market.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amarin, Avrobio, Immedica, Neoimmunetech, Orthox, Provepharm, Rznomics, SK.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Atara, Bio-Thera, Endevica, Evolus, Glenmark, Humanigen, Hutchmed, Optinose, Pluristem, Rhythm, Sanotize, Vaxcyte, Xortx.
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