The intellectual property waivers for American vaccines for the COVID-19 pandemic are still controversial, but the World Health Organization (WHO) is nonetheless seeking a similar set of waivers for therapies and tests for COVID. A subcommittee of the House Judiciary Committee met June 6 to review these waivers, and subcommittee chairman Darrell Issa (R-Calif.) said he intends to continue pushing legislation that would require the U.S. president to obtain congressional approval for agreeing to any such waivers in the future.
The EMA and the European Center for Disease Control have said COVID-19 vaccine manufacturers should ditch the existing formulations and adapt their products to target the omicron-descendant XBB.1.5, to protect against SARS-CoV-2 in the winter of 2023–2024.
Suzhou Spring-Sea Bio-Pharmaceuticals Co. Ltd. has prepared and tested prodrugs of N4-hydroxycytidine (NHC) that are reported to be useful for the treatment of SARS-CoV-2 infection (COVID-19).
U.S. FDA inspections are not always a pleasant experience, particularly when the end result is a warning letter. One company, Sea-Long Medical Systems LLC of Waxahachie, Texas, says the experience was a positive experience in that the company’s new ownership gained an important appreciation for the necessary rigors of medical device manufacturing.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acticor, Aridis, Ascentage, Cocrystal, IGM, Pepgen, Pharmazz, Precigen, Rocket.
Insilico Medicine IP Ltd. has synthesized 3C-like proteinase (3CLpro; Mpro; nsp5) (SARS-CoV-2; COVID-19 virus) inhibitors reported to be useful for the treatment of SARS-CoV-2 infection (COVID-19).
Researchers from NYU Grossman School of Medicine reported on a new strategy intended to provide long-term protection against the SARS-CoV-2 virus using an experimental decoy.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akebia, Amylyx, Beigene, Bristol Myers Squibb, Inhibrx, Iovance, Janssen, Lexicon, Metriopharm, SK, Valneva.
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