Vaccines
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Covid-19 roundup: Boosters for kids, CAR-NK cell therapy, Paxlovid rebound & more
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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HilleVax’s IPO hauls in $200M for clinical test of VLP norovirus vaccine from Takeda
Takeda Pharmaceutical spinout HilleVax broke the biotech IPO drought with a $200 million stock market debut for clinical development of a norovirus vaccine. Two eye health companies marked the other IPO activity: Belite Bio went public while Bausch + Lomb set financial terms for what could become one of the biggest IPOs of the year.
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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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Covid-19 vaccines & therapies helped push medicines spending to $407B in 2021
While Covid-19 has had a significant impact on drug spending, IQVIA projects that its effect will moderate in coming years. IQVIA’s new report on U.S. medicines spending projects that immunology, oncology, and neurology will continue to drive the growth in drug spending.
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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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Sanofi, GSK Covid-19 vax is now ready for regulators; its future may be as a booster
Sanofi and GlaxoSmithKline weathered clinical trial delays for their Covid-19 vaccine, but the partners now have data to support filings seeking regulatory authorizations. Key features of the vaccine may be able to persuade the vaccine hesitant; it may also be well-suited for use as a booster.
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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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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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With claims of potential Alzheimer’s edge, Vaxxinity squeaks out $78M IPO
Vaxxinity, a clinical-stage biotech with vaccine technology that gets the body to produce therapeutic or protective antibodies, raised $78 million from an IPO that priced below the targeted price range. In addition to its lead Alzheimer’s disease program, Vaxxinity’s pipeline includes product candidates for Parkinson’s disease, migraine, and Covid-19.
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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.
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Gates Foundation commits up to $90M for Inventprise pneumococcal vax trials
Vaccine biotech Inventprise has developed technology that offers broader protection than currently available products. Its lead program, a pneumococcal vaccine candidate, is being readied for tests in humans and it now has a financial commitment of up to $90 million from the Bill & Melinda Gates Foundation.
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FDA panel supports J&J Covid-19 vaccine booster; no vote on mixing and matching
Johnson & Johnson won the support of an FDA advisory panel, which unanimously recommended a booster shot for adults. The backing comes one day after the panel’s affirmative vote on a Moderna vaccine in a busy week of regulatory developments for Covid-19 vaccines, therapies, and diagnostics.
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Devices & Diagnostics, Pharma, BioPharma
Life sciences use of digital twins mirrors its application in other industries
Life sciences companies are using “digital twins” for everything from drug discovery to manufacturing. A panel of experts at MedCity News’ INVEST Digital Health conference discussed how this capability to run virtual simulations is changing practices now while also shaping the industry for the years to come.
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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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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.