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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aidoc, Arterys, Escala, Seegene.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascletis, Beigene, Bionecure, Bioxcel, Dialectic, GSK, Innovent, Iovance, Merck, Novartis, Sellas, Tonix, UCB, Vir.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Antengene, Arcutis, Astrazeneca, Avadel, Direct, Eucure, Everest, Intrommune, Kintor, Lutris, Pepgen, Rhythm, Sanbio, United Biomedical, United Therapeutics.
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