Pfizer and BioNTech have completed their filing seeking FDA emergency use authorization of their omicron-adapted Covid-19 booster shot. Production of this bivalent vaccine has already begun, enabling the companies to begin distribution as soon as the FDA authorizes the shot.
The FDA has granted the Pfizer and BioNTech Covid-19 full approval for use in adolescents. In other Covid-19 news, pharmacists were granted additional prescribing powers for an antiviral and Novavax’s European marketing authorization has been expanded to an additional age group.
There are a number of criteria for selecting the best autism therapy centers. Parents choosing a facility or professionals seeking to improve their offerings should consider certain standards to ensure the right fit.
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.
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.
Covid-19 vaccines from Pfizer and Moderna now have FDA emergency use authorization for children as young as 6 months old. If the Centers for Disease Control and Prevention signs off on these shots this weekend, these pediatric vaccines could become available for distribution early next week.
Pfizer and BioNTech reported positive clinical data for a Covid-19 booster in children younger than 5, results released ahead of a June FDA advisory committee meeting scheduled to discuss the use of that vaccine and Moderna’s in kids. In other Covid news this week, the CDC issued a health advisory for Pfizer’s antiviral Paxlovid and a respiratory failure drug for Covid-19 flunked its clinical trial.
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Pfizer and BioNTech reported preliminary clinical data supporting use of their Covid-19 vaccine as a booster in children ages 5 to 11. In other Covid news, a vaccine developer won marketing authorization in Europe while another one faces a regulatory setback.
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.
Alnylam Pharmaceuticals has proprietary lipid nanoparticle technology used in its FDA-approved RNA therapies. The biotech company claims that the messenger RNA Covid-19 vaccines from Moderna and Pfizer infringe on a patent covering this LNP technology.
BioNTech is acquiring a preclinical T cell receptor program (TCR) from Medigene, as well as licenses to the biotech’s TCR technologies. The agreement helps BioNTech expand its scope in cancer immunotherapy with a new approach for addressing solid tumors.
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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.
The FDA has expanded emergency authorization of Covid-19 boosters to include children 12 to 15 vaccinated with the Pfizer and BioNTech messenger RNA shot. The decision is based on a study that found boosting reduced deaths by 90%, but that Israeli analysis only evaluated these shots in people 50 and older.
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.
The new Covid-19 variant, named Omicron, has mutations that could help it evade antibodies produced by the immune system. Scientists are conducting lab tests to better understand this new variant and pharmaceutical companies are testing how existing vaccines, as well as those in development, measure up the new mutations.
The FDA has authorized dosing of booster shots of Pfizer and BioNTech's Covid-19 vaccine. Consistent with the recommendations of an FDA advisory committee, the agency’s amendment to the emergency authorization covers only certain groups at high risk of infection and complications from the virus.