Vaccines
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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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Payer’s Place: Dawn Maroney
Dawn Maroney, President, Markets of Alignment Health and CEO of Alignment Health Plan, to discuss how they are using technology to provide better service and care to consumers.
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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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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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Merck Vaccines Pipeline Gets Boost Via Deal for Opko Candidate for Epstein-Barr
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.
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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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Applying Remote Patient Monitoring to Surgery Prep and Recovery, Oncology and Women’s Health
Join us to learn about the latest trends in remote monitoring and how to extend its benefits beyond chronic conditions to more patients – all while using fewer staff resources.
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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.
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Feds commit $3.2B to lock in Covid-19 vax supply ahead of fall vaccination campaign
New Covid-19 vaccine booster shots are coming and they’ll include protection against the omicron variant. The U.S. government agreed to a purchasing contract covering 105 million doses of the Pfizer/BioNTech vaccine for a planned vaccination campaign in the fall.
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BIO panel: How Covid-19 is preparing us to better respond to the next pandemic
Biopharmaceutical companies and public health officials have learned a great deal about pandemic response in the last two years. A panel discussion during the annual meeting of the Biotechnology Innovation Organization explored some of the lessons from Covid-19 and how they can prepare us for the next pandemic.
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GSK gets pneumococcal vaccine contender with $2.1B Affinivax acquisition
Pfizer and Merck have each won FDA approvals in the past year for new pneumococcal vaccines, but GSK aims to top both of them with its $2.1 billion acquisition of Affinivax. That biotech’s Phase 3-ready vaccine candidate addresses more bacterial strains than any pneumococcal vaccines currently available.
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Payer’s Place: Dr. Anil Singh
Dr. Anil Singh shares his insights into the strategies employed by the organization to identify the most effective digital solutions for their members.
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Discover the Next-Gen Platform for Integrated Collaborative Care
Beyond EHRs and digital front doors, reducing the gaps in patient care journeys.
