Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ADC, Alnylam, Beigene, Chiesi, Hummingbird, Hutchmed, Instil, Mirum, Monopar, Redhill, Relief, Scynexis, Tonix, Y-Mabs.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Visby Medical.
The Biden administration may have jumped ahead of the FDA review when it announced last month that it planned to roll out COVID-19 boosters by Sept. 20, but that’s not likely to happen when it comes to the timing of vaccines for young children.
Shares in France’s vaccine specialist Valneva SA were sharply down after the U.K. government tore up a contract to supply 100 million doses of its COVID-19 vaccine, codenamed VLA-2001. Until today, Valneva was one of the largest COVID-19 vaccine contractors with the U.K. government, which got its orders early in the pandemic. Valneva was supposed to be supplying 100 million doses of its inactivated virus vaccine to the U.K., which had an option on a further 90 million shots.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alvotech, Apellis, Astrazeneca, Azurx, Cartargia, Cassiopea, Cytodyn, Mersana, Rezolute, Scpharmaceuticals, Senhwa, Sunovion.
The COVID-19 pandemic has exerted a significant effect on enforcement in the U.S., but Ethan Davis of King & Spalding (K&S) said federal prosecutors have made use of several novel approaches to prosecution in the past year.
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