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.
Lenzilumab, Humanigen Inc.’s lead candidate, undershot statistical significance on the primary endpoint in the U.S. NIH-sponsored ACTIV-5/BET-B study of treating hospitalized COVID-19 patients. The Short Hills, N.J.-based company’s stock (NASDAQ:HGEN) crumpled in the wake of the results.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Basilea, Bellus, Byondis, Citius, Cyxone, Dyne, Fresenius, Greenwich, Novartis, Y-mabs.
Legislation that would renew the U.S. FDA’s user fee programs is stuck in process on Capitol Hill, a predicament that seems to resist resolution to date. FDA commissioner Robert Califf said on a July 12 webinar that the FDA “is a decision-making machine” that is reliant on both user fees and congressional appropriations, and that a failure on the part of Congress to act on user fee legislation may force the agency to halt new hires and possibly lay off some FDA staff.
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