Two days after the U.S. FDA authorized a single booster dose of the Pfizer Inc.-Biontech SE COVID-19 vaccine for children ages 5 to 11, the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP) gave its blessing to the third dose.
Findings from three recent studies are shedding light on the pathways that are activated in severe cases of COVID-19, paving the way for earlier diagnosis and more targeted treatments.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acelrx, Active Biotech, Alnylam, Calliditas, Cansino, Cytovation, Gedea.
A year after the World Health Organization's (WHO) Independent Panel for Pandemic Preparedness and Response called for reforms to make COVID-19 the last pandemic, the panel remains solidly frustrated in its lack of progress.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alzamend, Ananda, Biontech, Cytokinetics, Gilead, Huyabio, Incannex, Janssen, Nouscom, Pfizer, Sorrento, Teva.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acuitas, Gilead, Homology, In8bio, Itolerance, Janssen, Kadimastem, Keros, Kyowa Kirin, Lassen, Luca, Metagenomi, Model, Neubase, Precision, Senti, Swanbio, Tonix, Vectory, Verastem.
While children younger than 5 in the U.S. still have no vaccine protection against COVID-19, those 5 and older may be able to get a third jab. The FDA authorized, May 17, the use of a single booster dose of the Pfizer Inc.-Biontech SE vaccine for kids 5 through 11 years of age who completed the primary two-dose series at least five months earlier.
An unknown U.K. biotech, RQ Biotechnology Ltd., has emerged from stealth mode with a $157 million licensing deal with Astrazeneca plc for its monoclonal antibodies, aimed at protecting vulnerable and immunosuppressed people against SARS-CoV-2.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Atamyo, Eli Lilly, Faron, Galera, Gedeon, Inmagene, Junshi, Mitsubishi, Point, Scpharmaceuticals, Sifi, Travere, Valneva, Zenas.
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