BARDA is contributing funding for a Phase 3 clinical test of a Moderna messenger RNA vaccine that could protect against the strains of bird flu virus now spreading in U.S. dairy cows. The Moderna vaccine is currently in Phase 1/2 testing.
Moderna’s mResvia is now the third FDA-approved RSV vaccine and the first one based on mRNA technology. It will compete for market share against RSV shots from GSK and Pfizer that won their FDA nods last year.
As technology advances, AI-powered tools will increasingly reduce the administrative burdens on healthcare providers.
In the face of these multifaceted threats, the need for innovative healthcare solutions becomes increasingly urgent. It underscores the vital role of the biopharmaceutical industry in not only addressing immediate health crises but also contributing to the broader resilience and well-being of humanity in times of adversity.
The next era for mRNA-based therapeutics and vaccines is here, and it’s time to move from an R&D mindset to a focus on long-term success with mRNA and bringing these innovative therapeutics to patients at scale.
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.
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.
Closing cancer health equity gaps require medical breakthroughs made possible by new funding approaches.
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.
Moderna’s mRNA vaccine for influenza has early data from a pivotal study showing it met trial goals assessing immune response against the more common strains of the virus, but missed against two less common types. A separate and ongoing Phase 3 study is assessing efficacy.
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.
Moderna is suing Pfizer and BioNTech, claiming they copied its messenger RNA work in developing their Covid-19 vaccine. The company notes that its patented work in respiratory infectious disease began years before the start of the Covid-19 pandemic, when the biotech was pursuing an mRNA vaccine for a different coronavirus.
Hear executives from Quantum Health, Surescripts, EY, Clinical Architecture and Personify Health share their views on digital transformation in healthcare.
Messenger RNA vaccine biotech CureVac is suing BioNTech, alleging that its rival’s Covid-19 vaccine infringes on intellectual property built on more than two decades of research. BioNTech responded that its work is original and the company will defend against the infringement allegations.
Oral delivery of messenger RNA is one of the capabilities of Matinas BioPharma’s technology. BioNTech will explore that feature among others under a new research alliance with Matinas, a clinical-stage biotech that also has an ongoing collaboration with Genentech.
Pfizer is paying BioNTech $225 million to kick off a new alliance aiming to develop a shingles vaccine based on the same messenger RNA technology that is the basis of the partners' Covid-19 vaccine. It’s the third alliance between the two companies, but this time Pfizer brings something more to the table.
Preliminary data suggest the BioNTech and Pfizer Covid-19 vaccine may have diminished protection against the omicron variant, but levels of neutralizing antibodies can be restored with a third shot. Real-world data are needed to further assess the vaccine’s efficacy against the new variant and whether an omicron-specific version of the shot is needed.
Sanofi’s strategy to develop new messenger RNA vaccines is adding another piece. The pharmaceutical giant struck a deal to acquire Origimm Biotechnology, a startup developing therapeutic vaccines to treat skin diseases and infections.