As largely expected, the FDA on Oct. 20 authorized the use of booster doses for COVID-19 vaccines from Moderna Inc. and Johnson & Johnson, in line with last week’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meetings. It also cleared the way for “mix-and-match” boosters, allowing eligible people to receive boosters from any of the FDA-approved vaccines, regardless of which vaccine they received originally.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Genetic Analysis, Icecure Medical, Nervotec, Osteocentric Technologies, Quest Diagnostics, UCB.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Aim, Alphageneron, Ambulero, Biogen, Biontech, Chipscreen, First Wave, Genmab, Janssen, Innocare, Moleculin, Pfizer, Plus, Sage.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abivax, Atea, Avadel, Avrobio, Cour, Dicerna, Edesa, Eli Lilly, Entasis, Galera, Harbour, Immune, Immunitybio, Inhibikase, Iterion, Noxxon, Ono, Opthea, Paratek, Pharnext, Seal Rock, Sifi, Small, Statera, Ultragenyx, Vyne.
Baidu Inc.’s preclinical studies showed the mRNA vaccine sequences for COVID-19 designed using its Lineardesign algorithm outperformed the benchmark sequences designed by traditional algorithms in terms of stability, protein expression and immunogenicity. The firm teamed up with Stemirna Therapeutics Co. Ltd., which specializes in the R&D of mRNA vaccines and drugs, to test seven mRNA COVID-19 vaccine sequences designed using Lineardesign.
Phase II results from Atea Pharmaceuticals Inc. with AT-527 in COVID-19 treatment had pundits scrambling to stack the odds of success for the direct-acting oral antiviral against those of Merck & Co. Inc.’s molnupiravir, though cross-trial comparisons are beset by the usual hurdles, with two especially dramatic ones.
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