Vaccines
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Novavax and Gavi Settle Dispute Over Covid Vaccines Pact, Avoiding Arbitration
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.
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AstraZeneca’s Icosavax M&A Deal Helps It Stand Out in Multivalent Vaccines Chase
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.
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Trayt Health Seeks to Increase Access to Diagnoses and Treatments
CEO Malekeh Amini explains how Trayt Health can bridge the gap for patients seeking neurological care.
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FDA Authorizes Novavax’s Covid-19 Vax, Set to Join Fall Rollout of Updated Shots
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.
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FDA Approves Updated Covid-19 Vaccines to Address Now Circulating Variants
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.
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GSK Patent Suit Aims to Halt Pfizer’s RSV Vaccine for Adults, But Not Infants
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.
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First FDA Approval of an RSV Vaccine Goes to GSK
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.
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Orbital Therapeutics Raises $270M to Bring RNA-Based Medicines to New Heights
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.
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The Public Health Emergency Is Expiring, So What Is the Future of Covid-19 Vaccines?
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.
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FDA’s Covid-19 Changes Set Stage for the Vaccines to Emulate Seasonal Flu Shots
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.
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Improving Communication Between Patients and Providers
Sarah Shillington, Chief Customer Officer notes how Artera’s omnichannel platform works.
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Pill Vaccine Biotech Vaxart Suspends Covid-19 Trial, Keeps Norovirus Focus
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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GSK’s Covid-19 Valentine to Vir Biotech: ‘You Can Go Your Own Way’
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.
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NIH Marburg Vaccine Posts Encouraging Results in First-in-Human Study
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.
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J&J Stops Work on HIV Vaccine After Failure in Phase 3 Clinical Trial
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.
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Pfizer RSV Vaccine Hits Trial Goal for Infants; Year-End FDA Filing Planned
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.