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 funding boost Moderna Inc. had expected via a roughly $590 million Biomedical Advanced Research and Development Authority award now looks to be off the table. The company disclosed May 28 that the U.S. Department of Health and Human Services (HHS) said it will terminate the award for late-stage development and right to purchase pre-pandemic influenza vaccines.
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.
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.
Drug resistance to epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors, occurring via secondary mutations or bypass pathways, is frequent among non-small-cell lung cancer patients.
The appointment May 6 of Vinay Prasad as the head of the U.S. FDA’s Center for Biologics Evaluation and Research (CBER) “bodes poorly” for Sarepta Therapeutics Inc.’s development-stage pipeline, said Wainwright analyst Mitchell Kapoor – and Wall Street reflected as much, as the stock (NASDAQ:SRPT) ended that day down 26.6% vs. an XBI drop of 6.6% – this ahead of the after-hours earnings disclosure that pushed the Cambridge, Mass.-based firm down even farther by more than another 20%, with the XBI unchanged.
Researchers from the Access to Advanced Health Institute and collaborating institutions have developed a promising new bivalent vaccine candidate that can protect against both yellow fever and Zika viruses. The study demonstrates that the vaccine elicits robust humoral and cellular immune responses in mice and hamsters and provides complete protection against lethal viral challenges.
U.S. FDA Commissioner Marty Makary is starting to fill the vacancies at the agency that’s seen its senior leadership ravaged by retirements and terminations. Makary’s first pick is Vinay Prasad as the new head of the FDA’s Center for Biologics Evaluation & Research (CBER), the center that oversees vaccines, blood products, allergenics and cellular, tissue and gene therapies.
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