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BioWorld - Sunday, April 5, 2026
Home » Moderna Inc.

Articles Tagged with ''Moderna Inc.''

US FDA bids adieu to monovalent COVID-19 vaccine

April 18, 2023
By Mari Serebrov
The latest U.S. FDA emergency use authorizations to fall by the wayside, as COVID-19 continues to evolve, are the ones for the first Moderna Inc. and Pfizer Inc.-Biontech SE’s mRNA vaccines.
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AACR 2023: Cancer vaccine trial results elicit reactions from 'indisputable' to 'cautious optimism'

April 17, 2023
By Anette Breindl
Combining the personalized cancer vaccine mRNA-4157 (V-940, Moderna Inc.) with Keytruda (pembrolizumab, Merck & Co. Inc.) significantly extended recurrence-free survival in patients with stage III/IV resected high-risk melanoma in the randomized phase II KEYNOTE-942/mRNA-4157-P201 trial. Compared to Keytruda alone, adding the vaccine cut the risk of recurrence or death by 44% 18 months after treatment, lead investigator Jeffrey Weber reported at the opening clinical trials plenary of the 2023 annual meeting of the American Association for Cancer Research (AACR).
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Moderna needs more sick people for its phase III flu study

April 11, 2023
By Lee Landenberger
On Vaccine Day, Moderna Inc. had to tell the world there weren’t enough flu cases to get a good reading in one of its two phase III vaccine studies. The northern hemisphere clinical trial of mRNA-1010, a seasonal quadrivalent vaccine, did not meet the statistical threshold because there were not enough sick participants to test to determine an interim efficacy analysis.
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Futuristic medicine research illustration with petri dishes and pipette
Drug Design, Drug Delivery & Technologies

Gandeeva and Moderna enter research collaboration using AI-enabled cryogenic electron microscopy

March 31, 2023
Gandeeva Therapeutics Inc. has entered into a research collaboration with Moderna Inc. to...
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DNA, drug development concept art.
Drug Design, Drug Delivery & Technologies

Moderna and Generation Bio collaborate to develop nonviral genetic medicines

March 24, 2023
Moderna Inc. and Generation Bio Co. have entered into a strategic collaboration to combine Moderna’s biological and technical expertise...
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Moderna vaccine vial and syringe on tray

Not just Moderna on the HELP hot seat

March 22, 2023
By Mari Serebrov
While Moderna Inc. CEO Stéphane Bancel was the one on the hot seat at a March 22 hearing before the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee, biopharma profitability in general, and capitalism itself, came under fire as committee Chair Bernie Sanders (I-Vt.) railed about corporate greed in the sector.
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Mixed results for Moderna’s flu vaccine

Feb. 17, 2023
By Lee Landenberger
The A’s have it but the B’s don’t in Moderna Inc.’s pivotal phase III study of mRNA-1010, a seasonal flu vaccine for adults living in the southern hemisphere. Interim results showed the vaccine achieved superiority on seroconversion rates for influenzas A/H3N2 and A/H1N1, superiority on geometric mean titer ratios for influenza A/H3N2 and noninferiority on geometric mean titer ratios for influenza A/H1N1. However, noninferiority was not met for the endpoints against the influenza B/Victoria- and B/Yamagata-lineage strains.
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FDA vaccine illustration

VRBPAC backs simplification of COVID-19 vaccines

Jan. 26, 2023
By Mari Serebrov
Harmonization and simplification won the day as the U.S. FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) looked toward the future of COVID-19 vaccines in the U.S. Jan. 26. The committee voted unanimously, 21-0, to recommend using the same strain composition for all COVID-19 vaccines available in the U.S., whether they’re used for primary doses or boosters. Such standardization also would align the composition of Novavax Inc.’s protein-based vaccine with that of the mRNA vaccines produced by Moderna Inc. and Pfizer Inc.-Biontech SE.
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COVID-19 vial, syringe and vaccine card

US FDA seeks simple path forward for COVID-19 vaccines

Jan. 24, 2023
By Mari Serebrov
As the SARS-CoV-2 virus that’s responsible for COVID-19 continues to evolve across the world, a global response, similar to what’s used with influenza, would be ideal in evaluating and recommending vaccine strain composition changes from year to year. But “the current diversity of vaccine manufacturers and complexities in global supply of COVID-19 vaccines would make a globally coordinated, simultaneous vaccine composition evaluation and recommendation quite challenging,” the U.S. FDA said in its briefing document for the Jan. 26 meeting of the Vaccine and Related Biological Products Advisory Committee. 
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Moderna’s RSV vaccine races to catch up with Pfizer and GSK

Jan. 18, 2023
By Lee Landenberger
Now there are three. Moderna Inc. has posted strong phase III study data on its mRNA respiratory syncytial virus (RSV) vaccine, keeping pace with Pfizer Inc. and GSK plc’s candidates, which have May PDUFA dates. Moderna’s top-line results of the ConquerRSV pivotal efficacy study of mRNA-1345 show the vaccine hit its primary efficacy endpoints of 83.7% against RSV-associated lower respiratory tract disease in older adults.
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