Moderna Inc. once again emerged the winner in a court skirmish over claims that its COVID-19 vaccine infringed two Alnylam Pharmaceuticals Inc. patents. The U.S. Court of Appeals for the Federal Circuit issued a precedential opinion May 4, agreeing with a federal district court in Delaware that Moderna didn’t infringe the patents. For both courts, the decision was based on a single issue of claim construction.
The articles in this collection are from BioWorld’s ongoing coverage of the COVID-19 coronavirus pandemic. They are available for free with registration. Note that we have added three critical tables, which are continuously updated:
Scientists at the Institute of Organic Chemistry and Biochemistry of the Czech Academy of Sciences have synthesized nonstructural protein 14 (NSP14) (coronavirus) inhibitors reported to be useful for the treatment of coronavirus acute respiratory syndrome.
Without convening the U.S. CDC’s Advisory Committee on Immunization Practices, Health and Human Services Secretary Robert Kennedy decided to bring the government’s COVID-19 vaccine recommendations in line with the FDA’s new “evidence-based” approach to the shots.
Consejo Superior de Investigaciones Científicas (CSIC) has synthesized antiviral compounds reported to be useful for the treatment of coronavirus acute respiratory syndrome.
Five years after the COVID-19 pandemic gripped the world, the U.S. FDA is moving away from annual routine boosters for all children and adults. Instead of that one-size-fits-all regulatory framework by which it has granted broad COVID-19 vaccine marketing authorization for all Americans older than 6 months, the agency said it’s adopting a policy akin to that followed in Europe, which now restricts the vaccines to older adults and those at high risk for severe disease.
Frets about how the new federal administration might affect prospects for vaccines were quelled at least somewhat by the U.S. FDA green light for Novavax Inc.’s COVID-19 vaccine Nuvaxovid, indicated for adults 65 and over and people 12-64 years old with at least one underlying condition that puts them at risk of severe outcomes from infection by the virus.
In a paradigm shift from private-sector partners, the U.S. Department of Health and Human Services (HHS) and the NIH announced May 1 the development of Generation Gold Standard, a next-generation, universal vaccine platform that uses a beta-propiolactone-inactivated, whole-virus to target pandemic-prone viruses.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alx Oncology, Cytoagents, Genentech, Geovax, Neurocrine, Realta, Roche, Vyne.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cel-Sci, Novavax, Pharming.
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