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An international clinical trial led by the Global Antibiotic Research and Development Partnership (GARDP) seeking improved antibiotic treatments for newborn sepsis has expanded to India. Neonatal sepsis is one of the leading causes of newborn deaths worldwide and is becoming harder to treat due to rising antibiotic drug resistance. Newborns have long been underrepresented in antibiotic research, leaving health care providers without an evidence-based standard-of-care treatment. The lack of a standard treatment has in turn complicated neonatal sepsis research because there is no obvious treatment to use as a comparison in trials. The trial aims to test and rank multiple potential antibiotic combinations for neonatal sepsis.Last week, the World Health Organization announced that a clinical trial evaluating two potential antiviral therapeutics for the Bundibugyo strain of Ebola will be launched in the Democratic Republic of the Congo next week amid the ongoing outbreak. There are currently no approved vaccines or therapeutics for the Bundibugyo strain, which is only known to have caused three outbreaks in history. The trial will evaluate the ability of Mapp Biopharmaceutical’s MBP134 and Gilead Sciences’ remdesivir to reduce mortality in patients, alone and in combination. The United States and Gilead Sciences are donating all the doses that will be used in the trial.The US Food and Drug Administration (FDA) has approved the first generic version of rifapentine as part of combination treatment regimens for active and latent pulmonary tuberculosis (TB). Rifapentine was first approved by FDA in 1998 to treat pulmonary TB. For active pulmonary TB cases in patients 12 or older, the generic antibiotic is approved only in combination with one or more anti-TB drugs, while for latent TB cases, the generic is approved in combination with isoniazid to treat patients 2 or older at high risk of progressing to TB disease.

Last week, the Food and Drug Administration’s (FDA’s) Vaccines and Related Biological Products Advisory Committee voted unanimously to recommend approval of Moderna’s mRNA influenza vaccine for older adults. In a Phase 3 trial in more than 40,000 adults in 11 countries during the 2024-2025 flu season, the vaccine demonstrated significantly better protection than standard-dose shots. Moderna's vaccine also uses mRNA technology, meaning it can be updated more quickly to match circulating flu strains compared to traditional vaccines that use egg-based methods. After initially agreeing to review the vaccine, the FDA had previously raised concerns about the Phase 3 trial for the vaccine, prompting backlash from vaccine and public health experts, before deciding to go ahead with its review. Following the recommendation, the FDA will make a final decision on approval, which is expected by early August.The Global Health Innovative Technology (GHIT) Fund has started an emergency framework to surge support and funding for the development of rapid and point-of-care diagnostic technologies in response to the Ebola outbreak caused by the Bundibugyo virus in the Democratic Republic of the Congo and Uganda. There are currently no approved vaccines, therapeutics, or point-of-care diagnostics for Bundibugyo virus. GHIT Fund is prepared to support fast-track funding for infections caused by filoviruses, which include Ebola, with the aim of advancing a diagnostic test, particularly one that is suited to low- and middle-income countries with limited infrastructure, that can improve control capacity for this and future outbreaks.  Inflammatix is collaborating with the University of Nebraska Medical Center to explore the use of the company’s diagnostic test platform for hantaviruses after the recent hantavirus outbreak exposed gaps in testing capacity due to limited technology and testing standards. Inflamattrix’s TriVerity test is a blood-based test that used machine learning to detect infection. It previously received clearance from the US Food and Drug Administration as a sepsis test in 2025. The partners are aiming to develop a tool that can assess the early signatures of infection in people with high-risk exposure to the virus, which could help improve early response capacity in future outbreaks.  

Fatherhood is often framed as a life milestone, but far less attention is paid to men’s role in deciding if or when that milestone occurs. Nearly half of all pregnancies, around 121 million globally each year, are unintended, highlighting major gaps in contraceptive access and limitations in today’s methods. Boosting investment in the research and development (R&D) of new and improved contraceptive options, including for men, offers a critical opportunity to strengthen reproductive autonomy, advance gender equality, and help prevent unintended pregnancy. The gendered burden of pregnancy prevention Without male contraceptive options beyond condoms and vasectomy, the physical, financial, logistical, and emotional burden of pregnancy prevention has long fallen on women.  While a wide range of options exist for women, from pills to injections, patches, and implants, an estimated 257 million women worldwide who want to avoid pregnancy are not using safe, modern methods of contraception due to a combination of social barriers (such as cultural or religious opposition), structural challenges (including limited access to high-quality services or education), and technological limitations (such as unpleasant side effects or short duration of protection). These barriers are especially pronounced in low- and middle-income countries—in sub-Saharan Africa, nearly one in four women has an unmet need for contraception.  Addressing this gap requires expanding options for women, such as methods that are longer acting, more discreet, have fewer side effects, and require fewer health care provider visits, as well as expanding contraceptive choice for men. New male contraceptive options to replace or complement female contraceptives could help rebalance the shared responsibility for family planning, empower men to have greater autonomy over their own reproductive health decision-making, and contribute to reducing unintended pregnancy. The gap in male contraception Limited innovation in male contraception reflects decades of underinvestment—not a lack of demand. Research shows strong interest in male contraceptives among men in diverse settings worldwide, alongside high trust in male partner birth control use among female partners, with preferred product types and attributes varying across contexts. Despite this clear demand, progress in male contraceptive innovation has been slow, in part due to the limited funding landscape. Contraceptive R&D has relied heavily on public and philanthropic funding, with the Gates Foundation playing a lead role. Private-sector engagement has remained limited due to perceived uncertainty about the potential market, unclear regulatory pathways, high development costs, and the broader historical underinvestment in contraception R&D. The continued success of products currently in clinical development has the potential to spark greater engagement in the field from diverse investors. Male contraceptive innovations on the horizon  While the pipeline lags behind demand, several exciting and innovative tools and approaches are advancing through clinical development.  The most advanced product in development is a reversible hormonal gel, NES/T, which can be applied once daily to the upper arms and shoulders. The gel is absorbed through the skin and suppresses sperm production. Originally developed by the Population Council and the US National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health and Human Development, it is now being advanced by Contraline, which recently announced the launch of Phase 3 trial planning. Nonhormonal male contraceptive options are another promising area of research because they target sperm function directly, avoiding hormone-related side effects. Contraline’s ADAM™ is a nonhormonal injectable device that blocks sperm flow for an extended period before dissolving. It has demonstrated encouraging safety and efficacy data in a first-in-human trial, with Phase 2 planning underway. YourChoice Therapeutics and Columbia University’s YCT529 is a first-in-class nonhormonal daily pill that suppresses sperm production and has shown positive results in a small, early human trial.  The path ahead When the US Food and Drug Administration approved the first oral contraceptive pill for women in 1960, its rapid, widespread adoption transformed reproductive autonomy and expanded economic, education, and career opportunities for women, carrying benefits that reverberated across entire economies and contributed to broader gender equality. Continued innovation in female contraceptives remains essential to ensure options better fit the needs and lifestyles of women worldwide.  But this progress should also be matched by investment in novel male contraceptives. Ensuring that everyone who wants to use contraception can access safe, effective, and acceptable options will expand choice, strengthen reproductive autonomy, and contribute to a more equitable and resilient future for family planning at a time when reproductive health protections are increasingly constrained worldwide. 

The Democratic Republic of the Congo has approved the use of a new single-dose oral treatment for sleeping sickness, a potentially fatal disease which is endemic in several countries in Central and West Africa. The approval of Acoziborole Winthrop, codeveloped by the Drugs for Neglected Diseases initiative (DNDi) and Sanofi, follows successful Phase 2 and 3 clinical trials conducted in the DRC and Guinea by DNDi in partnership with national authorities, which demonstrated that the drug is safe and effective. Existing treatments require a ten-day oral treatment regimen or a combination of injection and oral therapy that requires several days of hospitalization for patients in the most advanced stages. The DRC approval, which will make the drug available free of cost to patients in the country, is expected to be followed by endorsements in other endemic countries soon.A research team from the University of Maryland School of Medicine’s Center for Vaccine Development and Global Health has shared promising early results from a first-in-human clinical trial comparing a new investigational vaccine against Lassa fever and rabies to a licensed rabies vaccine, finding that the vaccine candidate was safe and induced rapid and robust immune responses against both viruses. There are currently no available vaccines for Lassa fever, a dangerous disease considered a priority threat with epidemic and pandemic potential that is common in parts of Western and sub-Saharan Africa, which also have a high burden of another severe disease: rabies. A dual vaccine could help streamline health care delivery in settings with limited health care infrastructure; the vaccine candidate can also be freeze-dried for storage, making it well suited to low-resource settings where it can be difficult to maintain the cold chain. Last week, DNDi, the Medicines for Malaria Venture (MMV), and the Global Antibiotic Research and Development Partnership (GARDP) announced a new cooperative agreement to explore how the three organizations can work together to advance global health research and development (R&D) amid global aid cuts and calls to reshape the global health architecture. The organizations plan to pool their expertise and resources to advance the R&D of effective and affordable medicines, while centering patient needs and equity. In addition, the partners will collaborate on policy advocacy and communications activities to raise awareness of the impact and promise of the nonprofit product development partnership model in advancing innovative, lifesaving medicines for critical, but often overlooked, diseases.