Moderna Inc. gained U.S. FDA approval on May 31, nearly three weeks past its original PDUFA date, for its respiratory syncytial virus (RSV) vaccine Mresvia (mRNA-1345), which had both breakthrough therapy and fast track designations in the U.S.
In a paper published in the May 17, 2024, online issue of Cell, investigators from the Duke Human Vaccine Institute reported that a sequence of three immunizations in the HVTN-133 trial was sufficient for the development of heterologous or broadly neutralizing antibodies that protected against several strains of HIV.
Citing the need to protect the public interest, the U.S. Department of Health and Human Services ordered an immediate government-wide funding suspension May 15 of Ecohealth Alliance Inc. while formal debarment proceedings are pending against the New York-based nongovernmental organization.
Osaka, Japan-based Shionogi & Co. Ltd. said May 13 that ensitrelvir fumaric acid (Xocova), its oral antiviral for COVID-19, showed no statistical difference against placebo in completely resolving 15 common COVID-19-related symptoms in a global phase III Scorpio-HR trial.
Is the U.S. getting the best return on investment (ROI) for its NIH buck? That’s the basic question at the heart of a white paper Sen. Bill Cassidy (R-La.) issued May 9 to continue a conversation he started in September on the reforms needed at the country’s premier biomedical research institution.
A licensing deal worth potentially up to $1.2 billion with Sanofi SA has breathed new life into Novavax Inc., which has struggled to compete in the COVID-19 space with powerhouses Pfizer Inc. and Moderna Inc.
The U.K.’s world-first subscription model for antimicrobials is to be expanded following a successful pilot scheme in which companies are being paid a fixed annual fee for their drugs, regardless of the volume dispensed.
The BioWorld Infectious Disease Index (BIDI) has continued to decline in the first four months of 2024, finishing April with a year-to-date decrease of 25.12%. BIDI trailed both the Nasdaq Biotechnology Index, which saw a 4.76% downturn by April’s end, and the Dow Jones Industrial Average, which closed the month with a 0.34% increase for the year. In 2023, BIDI ended the year with a 43.48% decline, preceded by an 83.57% drop in 2022.
Three years ago when Keting Chu pondered the name for a new biopharma company that would fold in infectious disease assets from Novartis AG, she looked out over her West Coast backyard. “I was looking for a name that made you think of California,” she told BioWorld. She nixed the idea of incorporating redwood trees into the name, but then she saw the blue jays flying around those trees and thought, “that’s a beautiful bird.” Hence, Chu founded and became CEO of Bluejay Therapeutics Inc., first raising $20 million through a series A in June 2021 and a $41 million series B in August 2022. On May 9, the San Mateo, Calif.-based company closed a $182 million series C round, with plans to accelerate development of lead compound BJT-778 to treat chronic hepatitis D virus, a condition for which there are no approved therapeutics in the U.S.
About a year ago, when Seres Therapeutics Inc. won U.S. FDA approval of oral microbiome therapy Vowst (live fecal microbiota spores), the drug – meant to prevent recurrent Clostridioides difficile infection – was hailed as first in the space, and launch plans sounded ambitious. In July 2021, Seres inked a deal with Nestlé Health Science SA, of Lutry, Switzerland, to jointly commercialize Vowst in the U.S. and potentially Canada. But shares of Cambridge, Mass.-based Seres (NASDAQ:MCRB) closed May 8 at 75 cents, down 36 cents, or 32%, after the firm provided an update on sales, roughly flat quarter over quarter.
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