In the summer of 2020, when Veru Inc. began researching sabizabulin for treating COVID-19 patients, the company’s CEO was cautioned that the virus could be gone by the time a therapy could be developed. Nearly two years later, Veru still has the compound in development and just reported phase III data that could propel it toward an emergency use authorization.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biogen, Deinove, Gilead, Glaxosmithkline, Merck, Neurosigma, Novavax, Serum Institute.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biontech, Beigene, Biocytogen, BMS, Boundless, Evotec, Indivior, Olix.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adverum, Henlius, Ilias, Minerva, Regeneron, Sanofi, Triastek.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abionyx, Akston, Annexon, Aptinyx, Ardelyx, Erytech, Meji, Pathalys, Talaris, Tonix, Vyne.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Akebia, Aosaikang, Aspect, Astrazeneca, Emergex, Everest, Genmab, Halozyme, J&J, Medisix, Melinta, Moderna, Propella, Twist, Vaccitech.
When the U.S. FDA convened its Vaccines and Related Biological Products Advisory Committee (VRBPAC) April 6 to advise on a path forward to the next generation of COVID-19 vaccines and boosters, there was a lot of talk about all the unknowns.
Citing the lack of clear evidence that vaccine protection against severe COVID-19 disease is substantially waning in the EU in people younger than 80, the European Centre for Disease Prevention and Control and the EMA’s COVID-19 task force concluded that it’s too early to consider using a fourth dose, or second booster, of mRNA COVID-19 vaccines in the general population.
Investigators at Boston Children's Hospital have demonstrated that SARS-CoV-2 infection of blood monocytes and lung macrophages in the lung could kill the cells via pyroptosis, increasing inflammation and leading to severe COVID-19.
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