Research Roundup: Prequalification for HCV self-test, Trial for antimalarials in pregnancy, Adjuvant boosts vaccines in mice
Global Health Technologies Coalition (GHTC)
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TOP NEWS IN R&D
WHO prequalifies first self-test for hepatitis C 360Dx (7/11)
Last Wednesday, the World Health Organization (WHO) announced that it had prequalified an at-home, over-the-counter assay for hepatitis C virus (HCV), the first self-test to be prequalified for HCV, which causes an estimated 1 million new infections globally each year. The prequalification of the assay, manufactured by OraSure Technologies, extends the 2017 prequalification of the company’s HCV test for professional use. Self-testing is recommended to complement existing testing services based on evidence demonstrating that it increases access to and uptake of services. The prequalification status will hopefully enable procurement in low- and middle-income countries, expanding access to HCV testing and treatment services and helping to contribute to the global goal of HCV elimination.
Africa-Europe partnership to launch historic Phase 3 clinical trial in early pregnancy Medicines for Malaria Venture press release (7/10)
The Safety of Antimalarials in First Trimester consortium, made up of scientific and social research experts on malaria in pregnancy has kicked off preparation for the first-ever Phase 3b clinical trial testing the efficacy and safety of antimalarials in women in their first trimester of pregnancy, which will be cosponsored by Medicines for Malaria Venture and the Liverpool School of Tropical Medicine. Pregnant women are typically excluded from clinical trials out of fear of causing harm, leaving few medicines for malaria treatment and no medicines for prevention available for women in their first trimester despite the significant health risks associated with malaria in pregnancy. The data from this trial could enable pregnant women and all women of childbearing age to safely take these antimalarial medicines without risk of causing harm, as well as support the design of future trials targeting other infectious diseases affecting pregnant women in low- and middle-income countries.
'Active' vaccine adjuvant boosts COVID-19 and flu antibodies in mice Fierce Biotech (7/9)
New research has led to the discovery of a potent adjuvant, PVP-037, that could induce a greater, more durable, and broader immune response to vaccines. Adjuvants are compounds that enhance the immune response, which are key to vaccine development, particularly for inactivated virus vaccines. Researchers identified the compound by screening a library of more than 200,000 small molecules found in human immune cells. In mice, an optimized form of the adjuvant boosted antibodies against flu and SARS-CoV-2 when given alongside disease-causing antigens. The compound is stable, easy to work with, and can be formulated in most drug delivery systems, which would make it easier to integrate it into vaccine development. Further research will be needed to study how the adjuvant performs in the presence of actual pathogens, assess its impact on the durability of immune responses, and test whether it works across age groups.
NEWS FROM GHTC
Tiba wins BARDA contract to develop RNAi bird flu therapeutic Fierce Biotech?(7/11), features Johnson & Johnson and the Bill & Melinda Gates Foundation
A new injectable could prevent malaria. What's standing in its way? Devex?(7/11), features the Gates Foundation and PATH
J&J's tuberculosis med Sirturo lands full US, EU approvals after more than a decade on the market Fierce Pharma?(7/8), features Johnson & Johnson
HIGHLIGHTS FROM THE WEEK
German researchers continue commercializing sequencing-based pathogen ID test for sepsis 360Dx?(7/11)
Malaysia was on the brink of eliminating malaria – then a new parasite swung out of the jungle The Telegraph?(7/10)
Allucent selected for new BARDA decentralized trial initiative for pandemic preparedness Fierce Biotech?(7/10)
Precision Biosensor’s US subsidiary receives FDA EUA for Covid-19+flu combo diagnostic kit Korea Biomedical Review?(7/9)
领英推è
US government appeals Gilead's trial win in Truvada, Descovy patent fight Fierce Pharma?(7/9)
University of Florida researchers using up to $2.8M NIH grant to develop CRISPR-based HIV self-tests 360Dx?(7/9)
Real-world results confirm safety of RSV vaccine in pregnancy Gavi, the Vaccine Alliance article (7/8)
AVIAN FLU R&D ROUNDUP
Health officials pitch anonymous bird flu testing Axios?(7/10)
New study sparks debate about whether H5N1 virus in cows is adapted to better infect humans STAT?(7/8)
H5N1 avian flu infects 2 children in Cambodia CIDRAP?(7/8)
UPCOMING EVENTS
July 23 Webinar: "The value of surveillance data in defining the medical need for new antimicrobials" Virtual
July 29-30 Global Pandemic Preparedness Summit 2024 Rio de Janeiro, Brazil
July 30 Congressional briefing: "Understanding the power and possibility of clinical trials" Washington, DC
October 8-10 Global Forum on TB Vaccines Rio de Janeiro, Brazil
December 5 GHIT R&D Forum 2024 Tokyo, Japan
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