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.
Valneva SE’s share price plummeted May 16 after the European Commission decided to terminate an advance purchase agreement for millions of doses of its COVID-19 vaccine candidate VLA-2001 because of delays in development. The company’s shares (Paris:VLA) fell more 19% to €9.65 (US$10.07) after it said it would reconsider its financial guidance for 2022.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Checkpoint, Clearmind, Editas, Hansa, Mitsubishi Tanabe, Neurocrine, Polarityte, UCB, Yiling.