MedCity News » Vaccines

Emergent BioSolutions’ smallpox vaccine, ACAM2000, now has an additional FDA approval covering mpox. It’s one of two FDA-approved mpox vaccines, joining Jynneos from Bavarian Nordic. Th...

https://medcitynews.com/2024/08/mpox-vaccine-fda-approval-emergent-biosolutions-acam2000-ebs/

Despite achieving strong responses against influenza A, a Phase 3 test of a Pfizer and BioNTech flu and Covid-19 combination vaccine did not meet goals against less common influenza B. These ...

https://medcitynews.com/2024/08/pfizer-biontech-influenza-covid-19-combination-vaccine-mrna-pfe-bntx/

Respiratory disease and immunology are the initial focus areas of GSK’s new drug discovery partnership with Flagship Pioneering. A similar Flagship alliance with Pfizer recently announced i...

https://medcitynews.com/2024/07/gsk-flagship-pioneering-drug-discovery-respiratory-immunology-vaccines/

HilleVax’s norovirus vaccine failed a Phase 2b study in infants, but it’s not the end of the road for the biotech. A business deal this year brought HilleVax a Phase 1-ready norovirus vac...

https://medcitynews.com/2024/07/norovirus-vaccine-hillevax-clinical-trial-fail-infants-hlvx/

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 Mod...

https://medcitynews.com/2024/07/moderna-mrna-vaccine-barda-avian-bird-flu-clinical-trial/

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...

https://medcitynews.com/2024/06/moderna-flu-covid-19-vaccine-combination-clinical-trial/

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...

https://medcitynews.com/2024/05/fda-approval-moderna-mrna-rsv-vaccine-mresvia/

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...

https://medcitynews.com/2024/02/novavax-gavi-covd-19-vaccine-arbitration/

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 c...

https://medcitynews.com/2023/12/astrazeneca-icosavax-acquisition-multivalent-vaccine-rsv-hmpv-vlp/

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 prote...

https://medcitynews.com/2023/10/fda-authorizes-novavaxs-covid-19-vax-set-to-join-fall-rollout-of-updated-shots/

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 Nov...

https://medcitynews.com/2023/09/fda-approves-updated-covid-19-vaccines-to-address-now-circulating-variants/

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 seaso...

https://medcitynews.com/2023/08/gsk-pfizer-rsv-vaccine-patent-lawsuit-arexvy-abrysvo/

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 l...

https://medcitynews.com/2023/05/fda-approval-rsv-vaccine-respiratory-syncytial-virus-gsk/

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 focu...

https://medcitynews.com/2023/04/orbital-therapeutics-raises-270m-to-bring-rna-based-medicines-to-new-heights/

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 feat...

https://medcitynews.com/2023/04/the-public-health-emergency-expiring-so-what-is-the-future-of-covid-19-vaccines/

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...

https://medcitynews.com/2023/04/fdas-covid-19-changes-set-stage-for-the-vaccines-to-emulate-seasonal-flu-shots/

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 cl...

https://medcitynews.com/2023/03/pill-vaccine-biotech-vaxart-suspends-covid-19-trial-keeps-norovirus-focus/

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...

https://medcitynews.com/2023/03/merck-vaccines-pipeline-gets-boost-via-deal-for-opko-candidate-for-epstein-barr/

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 toge...

https://medcitynews.com/2023/02/gsks-covid-19-valentine-to-vir-biotech-you-can-go-your-own-way/

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 incl...

https://medcitynews.com/2023/02/nih-marburg-vaccine-posts-encouraging-results-in-first-in-human-study/

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 fo...

https://medcitynews.com/2023/01/jj-stops-work-on-hiv-vaccine-after-failure-in-phase-3-clinical-trial/

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 i...

https://medcitynews.com/2022/11/pfizer-rsv-vaccine-hits-trial-goal-for-infants-year-end-fda-filing-planned/

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 t...

https://medcitynews.com/2022/06/feds-commit-3-2b-to-lock-in-covid-19-vax-supply-ahead-of-fall-vaccination-campaign/

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 Biotechnol...

https://medcitynews.com/2022/06/bio-panel-how-covid-19-is-preparing-us-to-better-respond-to-the-next-pandemic/

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 ...

https://medcitynews.com/2022/05/gsk-gets-pneumococcal-vaccine-contender-with-2-1b-affinivax-acquisition/

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...

https://medcitynews.com/2022/05/covid-19-roundup-boosters-for-kids-car-nk-cell-therapy-paxlovid-rebound-more/

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 th...

https://medcitynews.com/2022/05/hillevaxs-ipo-hauls-in-200m-for-clinical-test-of-vlp-norovirus-vaccine-from-takeda/

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 immun...

https://medcitynews.com/2022/04/covid-19-vaccines-therapies-helped-push-medicines-spending-to-407b-in-2021/

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 ...

https://medcitynews.com/2022/03/alnylam-sues-moderna-pfizer-claiming-covid-19-vaccines-infringe-lipid-patent/

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...

https://medcitynews.com/2022/02/sanofi-gsk-covid-19-vax-is-now-ready-for-regulators-its-future-may-be-as-a-booster/