In the hope of preventing thousands of hospitalizations and deaths over the next few months, the U.S. CDC’s Advisory Committee on Immunization Practice (ACIP) voted 13-1 Sept. 1 to recommend the use of Moderna Inc.’s and Pfizer Inc.-Biontech SE’s updated vaccines that contain components of both the original SARS-CoV-2 virus and the omicron BA.4/5 subvariants as boosters.
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.
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