By settling now and agreeing to deferred payments over the next five years, Novavax avoids the risk of being responsible for a much bigger payout all at once. The arbitration hearing over the disputed vaccine purchase agreement with Gavi was scheduled for this summer.
AstraZeneca is acquiring Icosavax, which has technology well-suited for multivalent vaccines. Icosavax's pipeline includes a Phase 3-ready program that protects against two pathogens that cause severe respiratory infections in older adults.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Novavax’s updated version of its Covid-19 vaccine is now FDA authorized for use in the U.S., joining the approved shots from Moderna and partners Pfizer and BioNTech. Novavax said its protein-based vaccine will be available in coming days.
The FDA said the updated messenger RNA vaccines from Pfizer/BioNTech and Moderna will protect against the omicron subvariants now prevalent in circulation. Left out of the FDA decision is Novavax, whose protein-based vaccine is still under regulatory review.
GSK claims that Pfizer’s FDA-approved vaccine for respiratory syncytial virus infringes on four patents protecting its own approved vaccine, Arexvy. The patent suit comes with the RSV season approaching.
FDA approval of GSK’s respiratory syncytial vaccine Arexvy covers adults age 60 and older—an age group at particular risk of developing severe complications from infection. GSK plans to launch Arexvy in time for the 2023/2024 RSV season.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
ARCH Venture Partners-backed Orbital Therapeutics’ is researching next-generation RNA medicines that offer advantages over currently available therapies. The startup’s three areas of focus are vaccines, protein replacement, and immunomodulation.
The FDA will decide this summer which strains the next Covid-19 vaccines should address. But companies are also taking a longer view, developing shots for the future that offer different features than the current ones and potentially broader protection against a wider range of pathogens.
Older adults and immunocompromised people may now get a second Covid-19 booster shot, according to amendments to the FDA authorizations of the mRNA vaccines. Further changes will be discussed at an advisory committee meeting planned for June.
Vaxart says its pill vaccines for Covid-19 still have advantages over injectable ones, but norovirus offers a faster path to validating its technology. The company is shelving its Covid-19 clinical trial in a corporate restructuring that will shave headcount by 27%.
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Merck has licensed global rights to an Opko Health vaccine in development for Epstein-Barr virus. The preclinical vaccine candidate, made with technology that displays multiple viral antigens to prompt an immune response, could compete against programs from Moderna and Valneva.
GSK gave Vir Biotechnology a Valentine’s Day break-up message, but it’s not a complete goodbye. Though the two companies are ending their Covid-19 collaboration, they’ll still work together on other respiratory programs, including a prophylactic influenza antibody drug that is in mid-stage clinical development.
Marburg virus has no FDA-approved vaccines or therapies, but a vaccine candidate from the National Institutes of Health now has encouraging results from a U.S. clinical trial. Next steps include tests in more countries including Ghana, where a Marburg outbreak was declared last summer.
Johnson & Johnson is stopping clinical development of an experimental HIV vaccine after the four-shot regimen did not beat a placebo in a late-stage study. The clinical trial failure comes follows the 2021 failure of the vaccine candidate in a different study population.
Pfizer’s respiratory syncytial virus vaccine candidate infants has clinical data showing it helped prevent severe infections in infants. It’s a maternal vaccine that produces antibodies in the mother that confer temporary protection to a baby.