Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amneal, Aston, Biontech, Genentech, Immusoft, Moderna, Pfizer, Roche, Sanofi.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bridge, Celsion, Ensysce, Helsinn, I-Cordis, Juniper, MC2, Quotient.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Algernon, Algo, Anaptysbio, Avacta, Axsome, Coya, Pliant, Reveragen, Santhera, Vaxart, Vyluma, Werewolf.
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.
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