The COVID-19 pandemic may or may not be over, depending on which member of the U.S. government’s executive branch one asks, but the FDA’s device center has drawn much tighter lines around its emergency use authorization (EUA) program for COVID-19 tests.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aqualung, Atea, Catalym, Everest, Pfizer, Y-mabs.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: AC Immune, Amerisourcebergen, Celsion, Cytrx, Lipocine, Navigo, Novavax, Outlook, Sciwind, Seagen, Synerk, Zai.
Valneva SE is approaching a crucial point with its troubled efforts to develop a COVID-19 vaccine, having announced Sept. 26 it’s in talks with a potential partner for its next-generation jab. The company cautioned the negotiations could take several months and may not succeed. The company’s problems with its COVID-19 vaccine, which is based on an inactivated whole virus, have weighed on its shares (Paris:VLA), which collapsed from a 52-week high of more than €29 (US$28.29) in December 2021 to €5.74 at the close of trading Sept. 26.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amniotics, Avenue, Bausch + Lomb, Biontech, Ferring, Glenmark, Infant Bacterial, Oncopeptides, Pfizer, Rebiotix, Spectrum.
As doctors and public health officials brace for a possible fall coronavirus surge, one of the challenges continues to be predicting who will have a mild, moderate or severe case of COVID-19.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Allogene, Aqualung, Chia Tai-Tianqing, Ensysce, Inventiva, Marinus, Pfizer, Plus, Servier, Sino, South Rampart, Tonix.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Alligator, Alnylam, Antengene, Aptevo, Artiva, Astrazeneca, Beigene, Bluebird, Bristol Myers Squibb, Cyxone, First Wave, Genentech, Heron, Leo, Medexus, Psyence, Roche, Seagen, Xortx.
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