Sweeping in behind Novavax Inc.’s positive phase III COVID-19 vaccine data is Johnson & Johnson’s single-shot COVID-19 vaccine, which met all the primary endpoints and key secondary endpoints in its phase III study, according to an interim analysis that found it to be 85% effective overall in preventing severe disease.
LONDON – A fourth COVID-19 vaccine is on the road to approval in Europe, with Novavax Inc. announcing positive interim data from the phase III U.K. trial of NVX-CoV2373. The vaccine was 89.3% effective at a time when there was a high rate of infection in the country, and in the face of the newly identified variant, B 1.1.7, which is more transmissible. There also was positive data, though slightly less sparkly, from a phase IIb study in South Africa, where NVX-CoV2373 showed 60% efficacy in preventing mild, moderate and severe COVID-19 disease.
Swift Biosciences Inc. released an S gene panel for SARS-CoV-2 that covers 100% of the gene even with minimal viral titers. The S gene controls the spike protein, which enables the virus to bind to cells and affects transmissibility, and has accumulated multiple mutations in the concerning variants recently discovered in the U.K., South Africa, Brazil, Denmark and the U.S. The panel is expected to enable rapid scaling of surveillance efforts of the new strains and can be run by any lab using the Illumina system.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Krishnamoorthi eyes ventilator contract; TGA fines company for failure to provide masks; U.S. PPE hoarder indicted; CAP supports Defense Production Act; South African variant in U.S.; GAO: More needs to be done to respond to COVID-19; Biden orders review of scientific-integrity policies.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advanced Medtech, DNA Genotekm, Global Instrumentation, Perspectum.
HONG KONG – Osaka, Japan-based Shionogi & Co. Ltd. has inked a license agreement with Bioage Labs Inc. that sets the stage for the Richmond, Calif.-based startup to test asapiprant, originally developed for allergic rhinitis, for the treatment of COVID-19 and age-related declines in immune function.
The latest global regulatory news, changes and updates affecting biopharma, including: Biden orders review of scientific-integrity policies; Canada to build rare disease drug strategy; South African variant in U.S..
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Antengene, Bio-Thera, Harbour, Immunoforge, Kintor, M6P, Opko, Passage, Pfizer.
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