Breakthroughs Blog

At the recent Union World Conference on Lung Health, TB Alliance presented the results of a Phase 2 clinical trial showing that the novel antibiotic candidate sorfequiline has the potential to improve tuberculosis (TB) treatment when combined with pretomanid and linezolid in people with drug-sensitive TB. The regimen was more effective than the current standard of care, and sorfequiline also demonstrated greater activity than bedaquiline, a key component of the BPaL regimen, a previous breakthrough that drastically reduced treatment time for most drug-resistant TB. This new treatment could shorten TB therapy even further. TB Alliance is working with partners ahead of the launch of a Phase 3 trial next year. Researchers at the University of California San Diego and partners have developed a new method to combat antibiotic-resistant bacteria, which could pave the way for developing alternatives to traditional antibiotics for treating a wide range of deadly infections, as the global threat of antimicrobial resistance continues to grow. The researchers used bacteriophages (or phages), which are viruses that infect and kill bacteria. Phages have been used to treat bacterial infections for more than 100 years but are usually limited in the bacterial strains they can successfully target. Researchers overcame this by allowing the pages to evolve alongside bacteria in a controlled laboratory setting for 30 days, enabling the phages to adapt their bacterial defenses, becoming more effective at killing a wide variety of bacterial strains, including drug-resistant ones, and better at suppressing bacterial growth for extended periods. Researchers at Indiana University have developed a molecular test that can simultaneously detect three dangerous fungi much faster than traditional methods, helping patients receive accurate, timely treatment against this growing global challenge. The test works by targeting genetic regions unique to each fungus, and it was much faster and more accurate than standard methods, a key advance as fungal infections are often mistaken for other respiratory illnesses. While the test still needs to be clinically validated in further studies, the research team believe it could eventually fill a major gap in fungal diagnostics. 

It’s been a difficult year for people worldwide who live with, are at risk of, or research HIV. Funding reductions and shifting priorities among key donors have disrupted or halted critical research and health services. Around the world, major international donors have reduced their funding for global HIV programming, leading to stoppages and cutbacks of lifesaving care. In the United States, new policies and grant terminations at the Department of Health and Human Services have significantly disrupted HIV research. The integration of the US Agency for International Development into the Department of State and resulting award terminations also interrupted HIV research and service delivery globally.These reductions risk undermining hard-won global progress and could lead to a resurgence in cases. Already, we’re seeing declines in HIV testing and treatment initiation this year. This is especially disheartening given exciting progress in recent years: at the end of 2024, new HIV infections were down 40 percent and AIDS-related deaths down 50 percent since 2010. The last few years have also brought exciting research advances, building momentum toward breakthroughs that could change the course of the global pandemic.With science yielding fruit and new donor countries and private funders stepping up, there is still hope that through renewed partnership and investment, we can regain momentum toward ending HIV/AIDS as a global public health threat. Here are some of the year’s most exciting advances in HIV research and innovation this year that inspire optimism amid significant challenges.A breakthrough in HIV prevention and accessIn June 2025, the US Food and Drug Administration approved lenacapavir as the first twice-yearly injectable drug for HIV prevention, marking a major milestone in the fight against the virus, While the drug, developed by Gilead using evidence from NIH-funded research, was previously approved for treating multidrug-resistant HIV, the new indication offers a discrete, twice-annual alternative to daily pills or bi-monthly injections, making prevention more accessible and easier to maintain. The approval followed highly successful clinical trials, which were notable not only for how effective the drug was across key populations, but also for their inclusion of historically underserved populations.Following the FDA’s decision, Gilead and the Global Fund to Fight AIDS, Tuberculosis and Malaria announced an access agreement that will see Gilead supply doses, at no profit, for up to two million people over three years. The Gates Foundation and Indian manufacturer Hetero Labs are also partnering to manufacture generic lenacapavir at an affordable price. The World Health Organization swiftly recommended the drug’s use, and South Africa’s regulatory authority approved it at record speed, the first such approval in Africa. It’s exciting to see partners work together to help ensure this breakthrough can be accessible in the communities where it is most needed quickly and affordably, a sharp divergence from past HIV product rollouts that saw years-long delays before people in low- and middle-income countries received access to new tools. Earlier this year, Gilead also published data suggesting a once-yearly version of the drug may be possible, with Phase 3 trials to begin later this year.Lenacapavir is not the only exciting advance in long-acting HIV prevention we saw in 2025. Merck’s investigational once-monthly oral prevention pill was found to be well tolerated in adults in a Phase 2 trial and is now undergoing Phase 3 trials in sub-Saharan Africa. Meanwhile, a single gene therapy injection given at birth showed promise in protecting primates from infection for at least three years in preclinical research. If this solution advances, it could be a gamechanger for preventing mother-to-child HIV transmission.Broadly neutralizing antibodies for long-term HIV control and cureBroadly neutralizing antibodies (bnAbs), which are made naturally by some individuals and target parts of the HIV virus that are less prone to mutation, are also showing promise in HIV treatment, prevention, and cure strategies. Studies have shown that bnAbs can effectively neutralize a broad range of HIV strains and bnAb combinations can maintain viral suppression in the absence of antiretroviral therapy, but challenges remain around their cost, global scalability, and the potential for viral resistance.Researchers are testing combination approaches with other drugs to potentially enhance the efficacy of bnAbs in controlling HIV. Study results presented earlier this year found that more than half of study participants living with HIV who received a pair of bnAbs plus the drug N-803 experienced delayed viral rebound or maintained a low or suppressed viral load during interruption from antiretroviral treatment. N-803, which is approved as a treatment for bladder cancer, appears to help reactivate and eliminate dormant HIV virus.Gilead also shared promising results from a Phase 2 trial earlier this year combining lenacapavir with two bnAbs as treatment for HIV. This regimen is the most advanced bnAbs-based treatment to date, with Phase 3 trials expected to start soon.Beyond treatment, many leading HIV scientists believe that a vaccine that elicits the production of bnAbs could be key to targeting the tricky, mutating virus. IAVI and partners developed immunogens, a type of antigen that can trigger an immune response, for use in a vaccine strategy to induce bnAb production, which demonstrated success in several Phase 1 clinical trials. A new study looking at data from two of the trials shows that this targeted vaccine strategy can successfully activate early immune responses relevant to HIV, an important step toward an HIV vaccine. The candidates use an mRNA vaccine platform, enabling faster production and clinical testing.While bnAbs have the potential to transform HIV prevention and treatment, further research is needed to overcome cost and delivery barriers to ensure that future innovations can be rapidly scaled up and distributed to the communities who can benefit most from them.While global HIV efforts have faced setbacks this year, we’ve also seen the extraordinary progress that’s possible when partners unite around innovation. New tools and approaches are emerging that could change the course of the global HIV/AIDS pandemic, preventing millions of new infections and deaths every year. But their impact depends on what happens next. To realize their full potential, countries, donors, and partners must come together and recommit to fund research, prioritize equitable access, and accelerate the scale-up of new tools. The future of the HIV/AIDS response hinges on how we meet this moment.

This fall, the global health community gathered against a backdrop of change. Shifts in global funding, visible pullbacks from multilateralism, and an evolving global development architecture are reshaping how actors engage and advocate on the world stage.For the Global Health Technologies Coalition (GHTC)—and for many others—this moment has prompted reflection on how we show up in global forums and what it means to engage meaningfully amid transition. Following a busy season of high-level gatherings, we’ve taken time to reflect on what these moments revealed—both in the lead-up and in the conversations that followed—and how they are shaping our thinking about GHTC’s role and path forward in these spaces. Reconnecting at UNGA80 In the run-up to this year’s 80th United Nations General Assembly (UNGA80), there was an unusual air of hesitation across the global health community. Typically, mid-August brings a flurry of coordination calls and side event planning, but this year, the energy felt uncertain. For GHTC, our initial hesitation to participate stemmed from UNGA’s focus on noncommunicable diseases (NCDs), an area outside our traditional advocacy repertoire. However, we also had questions about which of our partners would be in New York City this year and what our role could or should be in the tumultuous year we have all had. Yet, as it goes, we and other organizations confirmed our plans to attend UNGA, and soon, the familiar rhythm of civil society’s presence in New York began to take shape.  In New York, GHTC and the Global Health Council (GHC), with STUF United Fund, cohosted an event on innovation, security, and equity in a changing global landscape, which brought together policymakers, funders, and implementers to examine how global health can stay resilient amid geopolitical uncertainty. The discussion was lively and focused on the technical aspects of innovation, security, and equity, but afterwards participants commented not on those technical matters, but on our authentic and pragmatic approach and tone with which we addressed these topics. Audience members remarked that the discussion was one of the most genuine moments of the week. For GHTC, moderating this dialogue reinforced the need for global health advocates to bridge communities and connect innovators, funders, and policymakers around a shared vision for equitable access. It also reminded us that the credibility of civil society depends on showing up authentically, especially in moments of uncertainty or disagreement.  One striking development at UNGA this year came during the High-Level Meeting on NCDs, where the United States laid out objections to the political declaration and voted against it, taking consensus for the resolution off the table. While this move was not unexpected given the US government’s posture toward multilateralism this year, it was still a sobering moment. Secretary of Health and Human Services Robert F. Kennedy has made NCD prevention a national priority under his leadership at the department, yet his sharp criticism of the declaration underscored the United States’ continued reluctance to advance these goals through global cooperation. Women’s health as a catalyst for R&D transformation  As the global health community’s focus shifted from New York to Berlin, Germany for the World Health Summit (WHS), many of the same themes carried forward—innovation, equity, and the importance of collaboration amid shifting global priorities. After UNGA80, we saw how essential it was for civil society's voices to remain present and aligned in global conversations, and we viewed WHS as an opportunity to do just that. For us, a standout moment in Berlin was our participation in the Gates Foundation’s Women’s Health Innovation Equity Forum—a convening of global leaders, innovators, and funders dedicated to advancing accountability and progress in women’s health research and development (R&D).  What stood out the most at this forum was the shared understanding that women’s health R&D can be a testing ground for how we build a more equitable and collaborative innovation system overall. Conversations at the forum went beyond individual products or technologies to look at the broader ecosystem: how research can better reflect women’s lived experiences, how artificial intelligence and digital tools can be designed to avoid bias, and how we can create inclusive pathways from discovery to delivery. The call was not just to innovate for women but to innovate with women, by centering their voices, co-designing solutions that fit their realities, and ensuring that they are represented as leaders, scientists, and decision-makers throughout the R&D process. These ideas align with GHTC’s work to strengthen the global health innovation ecosystem. Our goal is to help make equitable, inclusive, and well-resourced innovation systems the rule, rather than the exception.  Reimagining the global health architectureOver the past several months, we've participated in a number of conversations, meetings, and working sessions aimed at reimagining how the global health architecture can be rebuilt stronger and more resiliently in the years ahead. One gathering, hosted by the Wellcome Trust just after WHS, brought a new focus and sense of shared purpose to this discussion, convening partners from across North America and Europe to explore the future of global health amid ongoing change and reform. This initial session focused on North American and European partners, with additional regional discussions planned to ensure perspectives from low- and middle-income countries and other stakeholders are fully represented as the series continues. The gathering brought together an extraordinary mix of leaders—funders, policymakers, researchers, and advocates—who are committed to reimagining how the global health ecosystem advances innovation and equity. Our discussions explored how the next generation of global health architecture could deliver faster, more inclusive, and stronger regional capabilities for research and manufacturing and more sustainable financing that bridges discovery and delivery. It was both humbling and energizing to be part of such a thoughtful, solutions-oriented dialogue at a moment when the global community is being called to reexamine what collective action really looks like.  For GHTC, these reflections really brought home why our coalition’s work matters. The conversations highlighted how innovation, access, and financing are all part of the same continuum, which is exactly what GHTC has been advocating for as we work to strengthen R&D systems, regulatory pathways, and product access. What struck us the most was the shared understanding that reforming global health innovation is not only a technical or financial issue but also a matter of trust, shared power, and accountability. We left the meeting encouraged and inspired, knowing that voices like ours, grounded in evidence, partnership, and advocacy, have an important role to play in shaping a more connected, inclusive, and resilient global health ecosystem. In Berlin, we also had the chance to join our partners, including the Medicines for Malaria Venture (MMV), Impact Global Health, and others, at events highlighting innovation and equitable access on the margins of the WHS. Finally, to close out our continued engagement with the civil society arm of the G20, we supported our partners—including the South African Health Technologies Advocacy Coalition, Resilience Action Network Africa, MMV, Better Health Solutions, and others—in hosting a side event on science, research, and innovation on the sidelines of the G20 Social Summit. This event highlighted the value of meaningful partnerships and global collaboration, reinforcing the importance of civil society's voices in shaping health innovation and research agendas worldwide. Looking aheadAs this season of global convenings draws to a close, GHTC is taking stock. We are reexamining our multilateral priorities and exploring how to continue showing up—strategically, collaboratively, and boldly—in spaces that are themselves evolving. We extend deep thanks to our partners—GHC, MMV, Impact Global Health, the South African Health Technologies Advocacy Coalition, Resilience Action Network Africa, Better Health Solutions, and many others—for the coordination and collaboration that made this season so meaningful. Even during a period of change, these gatherings reaffirmed that innovation, solidarity, and shared purpose remain at the heart of progress in global health. 

A Phase 1 randomized controlled trial found that a single dose of the ChAdox1 Rift Valley fever (RVF) vaccine was safe, tolerable, and elicited a strong immune response in 30 adults in Uganda, where RVF—a neglected, mosquito-borne disease that is considered a significant public health threat and a priority for vaccine development—is endemic. The trial was led by researchers at the Uganda Research Institute and the London School of Hygiene and Tropical Medicine Research Unit in Uganda and provides the first evidence supporting the vaccine from a trial in an endemic setting. While the vaccine could potentially be transformative for RVF prevention, further research is needed that follows participants for a longer period and includes a larger group of participants, including children, pregnant women, and immunocompromised people. Last week at the American Society of Tropical Medicine and Hygiene annual meeting, Medicines for Malaria Venture and Novartis shared the results of a Phase 3 study testing a new malaria treatment, known as GanLum, finding that the treatment was highly effective at treating malaria, including drug-resistant cases, and could also block disease transmission. GanLum was found to be 99.2 percent effective in curing patients, more effective than standard artemisinin-based combination therapies, the gold-standard malaria treatment introduced more than 20 years ago, whose use has been undermined since the emergence of partial resistance. The developers say that, pending regulatory approval, the new treatment could be rolled out within the next few years. South African pharmaceutical company Biovac is launching trials of a cholera vaccine, which, if it proves successful, could become the first vaccine developed from start to finish on the African continent. Africa faces the brunt of the global cholera burden but is almost entirely reliant on vaccines made internationally, which has become increasingly challenging in recent years as cases have risen sharply around the world and vaccine stocks have diminished. The African Union has committed to increasing the proportion of routine vaccines used in Africa that are manufactured on the continent from just 1 percent now to 60 percent over the next 15 years, an effort triggered by the access challenges African countries faced during the COVID-19 pandemic.