Top News in R&D





 Global Health Technologies Coalition 


R&D News Roundup: July 1, 2024


Top News in R&D

Roche molecular HPV test receives WHO prequalification
360Dx (6/27)

Last Thursday, Roche announced that its molecular Cobas HPV test received prequalification designations from the World Health Organization (WHO), a decision that will hopefully boost global efforts to eliminate cervical cancer through improved access to testing. The test received prequalification designations for use on the Cobas 5800 system and for self-collected samples on the Cobas 5800, 6800, and 8800 instruments, already having received WHO prequalification for use on the Cobas 6800 and 8800 systems last year. Prequalification will expand the availability of the test in many low- and middle-income countries that rely on prequalification to make regulatory, purchasing, and implementation decisions. Additionally, the use of self-collection, which was also recently approved by the US Food and Drug Administration, is expected to increase access to HPV testing by increasing comfort and ease for users.

CARB-X funds Prompt Diagnostics to develop a diagnostic to detect drug-resisant gonorrhea
CARB-X press release (6/27)

The Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) recently announced a $1 million award to Prompt Diagnostics to further the development of a portable, point-of-care platform to detect multiple pathogenic bacteria targets and their antibiotic susceptibility, an urgently needed technology to help address rising drug resistance globally. Rapid, sophisticated diagnostics can enable early detection of infections, more effective treatment management, and improved antimicrobial stewardship to help prevent the emergence and spread of drug resistance, particularly in low-resource settings where drug-resistant infections are particularly hard to treat and the burden of drug resistance is highest. Specifically, CARB-X hopes the platform will demonstrate feasibility for detecting gonorrhea infections in the face of disproportionately high rates of gonorrhea in low- and middle-income countries.

CRISPR-based genetic technique eradicates malaria mosquitoes with over 99% efficiency
NewsMedical (6/26)

New research shows that a novel genetic vector control technique is highly effective at reducing the population of Anopheles gambiae, the primary vector for malaria in Africa. The technology could eventually serve a crucial role in reducing malaria transmission, especially as conventional methods, including insecticide-based technologies and environmental controls, are becoming less effective due to insecticide resistance. The precision-guided sterile insect technique uses CRISPR, a gene-editing tool, to produce genetically modified highly sterile male mosquitoes that then mate with and sterilize female mosquitoes, leading to robust population suppression. Developers say that compared to other genetic modification technologies developed for this mosquito species, the new technique is safer, scalable, and confinable.



News from GHTC

FIND calls for tests to distinguish H5N1 avian flu from other flu subtypes
360Dx (6/27), features FIND

Liberia: PREVAIL begins vaccinations in the Phase 2a Lassa fever vaccine study
Independent Probe (6/26), features IAVI and the Coalition for Epidemic Preparedness Innovations (CEPI)

FDA, Gates Foundation partner to help develop breath-based Dx for underserved populations
360Dx (6/26), features the Bill & Melinda Gates Foundation

Gilead urged to prioritise access as injection trial proves 100% successful in preventing HIV
Health Policy Watch (6/24), features AVAC and the Medicines Patent Pool

Paediatric malaria treatment developed in Brazil by not-for-profit organizations distributed to Indigenous children in the Amazon region
Drugs for Neglected Diseases initiative press release (6/24)

Valneva announces Health Canada approval of the world’s first chikungunya vaccine, IXCHIQ®
Valneva press release (6/24), features CEPI



Highlights From the Week

Supreme Court undercuts regulators’ authority across government
STAT (6/28)

Cepheid receives FDA marketing authorization for point-of-care hepatitis C test
360Dx (6/28)

US CDC recommends updated COVID vaccines for those aged six months and older
Reuters (6/28)

Exclusive: Congo authorities approve mpox vaccines to try to contain outbreak
Reuters (6/27)

FDA grants traditional approval to TB treatment Sirturo
Medical Professionals Reference (6/26)

DHS: AI holds promises, risks for biosecurity
Axios (6/26)

Federal officials revise recommendations for R.S.V. vaccine
The New York Times (6/26)

FDA issues long-awaited draft guidance for enrolling more people of color in clinical trials
STAT (6/26)

DOD enlists Evotec subsidiary in antibody manufacturing program, awards up to $39M
Fierce Pharma (6/26)

Moderna says its RSV shot is 50% effective across a second season
Reuters (6/26)

NIH statement on preliminary efficacy results of twice-yearly lenacapavir for HIV prevention in cisgender women
National Institute of Allergy & Infectious Diseases news release (6/26)

BioMérieux respiratory/sore throat mini panel gets FDA special 510(k) clearance, CLIA waiver
360Dx (6/26)

Warnings over lethal and contagious strain of mpox as children in DRC die
The Guardian (6/26)
Additional coverage from Reuters (6/25)

Ex-Meta experts at AI-biotech startup offer tool to create new molecules
Axios (6/25)

Eli Lilly inks OpenAI deal for discovering new antibiotics
Fierce Biotech (6/25)

CDC issues dengue fever alert in the U.S.
NBC News (6/25)

It’s hard to find treatment for snakebites in Kenya. Thousands of people are dying every year
Associated Press (6/20)






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