An experimental Moderna combination vaccine for influenza and Covid-19 showed in a pivotal study that it can elicit a higher immune response compared to vaccines that are already available to protect against infection from both viruses.

The post Moderna’s Flu & Covid-19 Combination Vaccine Succeeds in Phase 3 Clinical Trial appeared first on MedCity News.

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.

The post FDA Approves Moderna RSV Vaccine, an mRNA Alternative to GSK and Pfizer Products appeared first on MedCity News.

By settling now and agreeing to deferred payments over the next five years, Novavax avoids the risk of being responsible for a much bigger payout all at once. The arbitration hearing over the disputed vaccine purchase agreement with Gavi was scheduled for this summer.

The post Novavax and Gavi Settle Dispute Over Covid Vaccines Pact, Avoiding Arbitration appeared first on MedCity News.

AstraZeneca is acquiring Icosavax, which has technology well-suited for multivalent vaccines. Icosavax’s pipeline includes a Phase 3-ready program that protects against two pathogens that cause severe respiratory infections in older adults.

The post AstraZeneca’s Icosavax M&A Deal Helps It Stand Out in Multivalent Vaccines Chase appeared first on MedCity News.

Novavax’s updated version of its Covid-19 vaccine is now FDA authorized for use in the U.S., joining the approved shots from Moderna and partners Pfizer and BioNTech. Novavax said its protein-based vaccine will be available in coming days.

The post FDA Authorizes Novavax’s Covid-19 Vax, Set to Join Fall Rollout of Updated Shots appeared first on MedCity News.

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 post FDA Approves Updated Covid-19 Vaccines to Address Now Circulating Variants appeared first on MedCity News.

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.

The post GSK Patent Suit Aims to Halt Pfizer’s RSV Vaccine for Adults, But Not Infants appeared first on MedCity News.

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.

The post First FDA Approval of an RSV Vaccine Goes to GSK appeared first on MedCity News.

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.

The post Orbital Therapeutics Raises $270M to Bring RNA-Based Medicines to New Heights appeared first on MedCity News.

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.

The post The Public Health Emergency Is Expiring, So What Is the Future of Covid-19 Vaccines? appeared first on MedCity News.

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.

The post FDA’s Covid-19 Changes Set Stage for the Vaccines to Emulate Seasonal Flu Shots appeared first on MedCity News.

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%.

The post Pill Vaccine Biotech Vaxart Suspends Covid-19 Trial, Keeps Norovirus Focus appeared first on MedCity News.

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.

The post Merck Vaccines Pipeline Gets Boost Via Deal for Opko Candidate for Epstein-Barr appeared first on MedCity News.

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.

The post GSK’s Covid-19 Valentine to Vir Biotech: ‘You Can Go Your Own Way’ appeared first on MedCity News.

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.

The post NIH Marburg Vaccine Posts Encouraging Results in First-in-Human Study appeared first on MedCity News.

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.

The post J&J Stops Work on HIV Vaccine After Failure in Phase 3 Clinical Trial appeared first on MedCity News.

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.

The post Pfizer RSV Vaccine Hits Trial Goal for Infants; Year-End FDA Filing Planned appeared first on MedCity News.

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.

The post Feds commit $3.2B to lock in Covid-19 vax supply ahead of fall vaccination campaign appeared first on MedCity News.

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.

The post BIO panel: How Covid-19 is preparing us to better respond to the next pandemic appeared first on MedCity News.

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.

The post GSK gets pneumococcal vaccine contender with $2.1B Affinivax acquisition appeared first on MedCity News.

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.

The post Covid-19 roundup: Boosters for kids, CAR-NK cell therapy, Paxlovid rebound & more appeared first on MedCity News.

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.

The post HilleVax’s IPO hauls in $200M for clinical test of VLP norovirus vaccine from Takeda appeared first on MedCity News.

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.

The post Covid-19 vaccines & therapies helped push medicines spending to $407B in 2021 appeared first on MedCity News.

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.

The post Alnylam sues Moderna & Pfizer, claiming Covid-19 vaccines infringe lipid patent appeared first on MedCity News.

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.

The post Sanofi, GSK Covid-19 vax is now ready for regulators; its future may be as a booster appeared first on MedCity News.

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 post Pfizer and BioNTech team up again, this time to develop an mRNA shingles vaccine appeared first on MedCity News.

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.

The post FDA expands Covid-19 boosters for kids using real-world data in much older adults appeared first on MedCity News.

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 post Concern about Covid-19 variant Omicron centers on spike protein mutations appeared first on MedCity News.

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.

The post With claims of potential Alzheimer’s edge, Vaxxinity squeaks out $78M IPO appeared first on MedCity News.

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.

The post Gates Foundation commits up to $90M for Inventprise pneumococcal vax trials appeared first on MedCity News.