BioNTech
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Covid news roundup: Boosters for kids, breath diagnostic, a vax approval & more
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.
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Aiming to make better mRNA vaccines, BioNTech strikes up alliance with Matinas
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.
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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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Alnylam sues Moderna & Pfizer, claiming Covid-19 vaccines infringe lipid patent
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.
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BioNTech broadens its scope in cancer with Medigene cell therapy alliance
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 and BioNTech team up again, this time to develop an mRNA shingles vaccine
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.
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FDA expands Covid-19 boosters for kids using real-world data in much older adults
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.
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BioNTech CEO: omicron is partial escape variant, but booster may restore protection
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.
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Concern about Covid-19 variant Omicron centers on spike protein mutations
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.
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FDA authorizes Pfizer Covid-19 vaccine booster shots, but only for certain groups
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.
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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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Pfizer reports positive Covid-19 vaccine data in kids; FDA filing is coming
A lower-dose version of Pfizer and BioNTech’s Covid-19 vaccine showed safety and efficacy results in children 5 to 11 that were comparable to those in an older age group. With these preliminary data, the companies said they plan to seek emergency use authorization of the shots.
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FDA panel backs booster shots in high-risk groups after rejecting broader proposal
An FDA advisory panel voted down a proposal for booster shots of the Pfizer/BioNTech Covid-19 in the general population, opting instead to support third shots in certain high-risk groups, such as the elderly. Panelists want to see more information supporting the need for a booster, as well as data about a heart safety risk the vaccine may pose to young males.
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FDA sets expectations for pediatric Covid-19 vaccines; decision could come mid-fall
Acknowledging the demand for a Covid-19 vaccine for children, the FDA said it expects regulatory review could take weeks, not months, depending on the timing of a submission from vaccine developers. U.S. health officials told Reuters they expect the Pfizer/BioNTech vaccine will be the first one ready for an FDA submission.
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Covid news recap: Comirnaty approved, J&J’s booster boast, new BD test & more
Full FDA approval of Pfizer and BioNTech’s Covid-19 vaccine was the biggest news in a busy week for coronavirus vaccines, drugs, and diagnostics. Here’s a look back at some of the major developments.
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Pfizer, BioNTech Covid-19 vaccine is awarded full FDA approval
Full FDA approval makes the Pfizer/BioNTech Covid-19 vaccine the first to reach that milestone. But the regulatory decision also flagged a potential risk of heart inflammation, particularly in young males, and the agency has asked the companies to conduct additional clinical research.
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FDA authorizes Covid-19 booster shots, but only for the immunocompromised
Covid-19 vaccine booster shots are now authorized for organ transplant patients and others who have weakened immune systems. The FDA based its update on the results of two small studies that tested third shots of the mRNA Covid vaccines from Moderna and Pfizer/BioNTech.
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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.
