As cases and deaths begin to level out, not showing the up-and-down spikes indicative of the first two COVID-19 pandemic years, the world may finally breathe a sigh of relief. But behind the scenes, the biopharma industry and global governments are not underestimating the evolving SARS-CoV-2 virus.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ecential Robotics, Genbody, Revelle, Viz.ai.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alnylam, Bio-Techne, Cerveau, Fluidx, Openeye, Pharmajet, Sense Biodetection, Tecomedical.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amgen, Biocardia, Bright Minds, Futura, Hepion, Hightide, Hillevax, Immunogen, Lannett, Madrigal, Recordati, Regenxbio.
The COVID-19 pandemic encouraged a lot of things, including shoddy product quality, but a recent FDA warning letter suggests that the associated need for tests also encouraged a few operations that had less than a full commitment to quality management.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Bavarian Nordic, Biocytogen, Biogen, Curis, Daiichi, Jaguar, Moderna, Novavax, Okyo, Outlook, Sanofi, Sobi, Stemcyte, Takeda, Y-mabs.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aim, Aristea, Clover, Connect, Cybin, Forge, Hemostemix, Janssen, Jounce, Journey, Poxel, Sangamo, Vascular.
Right on cue, the U.S. FDA authorized bivalent COVID-19 vaccines from Moderna Inc. and Pfizer Inc.-Biontech SE to be given as boosters at least two months following a primary vaccine series or a previous booster. “These updated boosters present us with an opportunity to get ahead of the next wave of COVID-19,” FDA Commissioner Robert Califf said, following the Aug. 31 announcement.
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