Breakthroughs Blog: Medicines

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email.The Medicines Patent Pool (MPP) has signed agreements with 27 generic manufacturing companies to produce and supply the oral COVID-19 antiviral molnupiravir for 105 low- and middle-income countries. The sublicense agreements follow a voluntary licensing agreement signed by MPP and Merck, Sharp & Dohme—which developed the drug—in October to facilitate global access of the COVID-19 treatment. The nonexclusive licenses allow generic manufacturers to produce the raw ingredients and finished drug itself: five companies will focus on producing the raw ingredients, thirteen companies will produce both raw ingredients and the finished drug, and nine companies will produce only the finished drug. Molnupiravir has not yet been approved by the World Health Organization (WHO), a step often regarded as a precursor to the negotiation of manufacturing licenses by a United Nations-supported group like MPP.Antimicrobial resistance (AMR) poses a significant threat to humanity, as it has become a leading cause of death worldwide killing about 3,500 people every day, according to a new study published in The Lancet last week. More than 1.2 million people—and potentially millions more—died in 2019 as a direct result of antibiotic-resistant bacterial infections. The analysis, which covered more than 200 countries and territories, is the most comprehensive estimate to date of the global impact of AMR, which has caused common infections to become untreatable. The report highlights an urgent need to scale up action to combat AMR and outlines immediate actions policymakers can take to help save lives and protect health systems, including optimizing the use of existing antibiotics, taking greater action to monitor and control infections, and providing more funding to develop new antibiotics and treatments.The COVAX vaccine-sharing facility has delivered 1 billion COVID-19 vaccine doses, across 144 countries, as of last weekend. The program, which was initiated in 2020 with the goal of delivering 2 billion doses by the end of 2021, began delivering vaccines in February 2021 but hit several setbacks throughout the year, including vaccine hoarding by high-income countries and export restrictions which limited vaccine supply. Shipments increased exponentially in the last quarter of 2021, but vaccine inequity remains high, according to the latest WHO data showing 67 percent of the population in richer nations have been fully vaccinated, compared with only 5 percent in poorer nations. More than 40 percent of the world's population has yet to receive a first dose. Gavi, the Vaccine Alliance, has launched a renewed call for COVAX funding to help reach WHO's goal of vaccinating 70 percent of the populations in poorer countries by July.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email.A World Health Organization (WHO) panel on Thursday recommended the use of two additional drugs, baricitinib and sotrovimab, for COVID-19 patients. Baricitinib, developed by Eli Lilly and sold under the brand name Olumiant, was recommended in combination with corticosteroids for patients with severe COVID-19. WHO experts cited evidence indicating that baricitinib—an oral drug also used to treat rheumatoid arthritis—improves survival rate and reduces the need for ventilation, with no observed increase in adverse effects. Sotrovimab, a monoclonal antibody therapy developed by GlaxoSmithKline (GSK) and Vir Biotechnology, was conditionally endorsed for non-severe patients at the highest risk of hospitalization. Studies on the effectiveness of monoclonal antibodies against the omicron variant are ongoing, though the GSK-Vir treatment has been shown to retain its activity in initial lab tests.An mRNA-based HIV vaccine candidate developed at the National Institute of Allergy and Infectious Diseases (NIAID) showed promise in preclinical studies, new research shows. The experimental vaccine works by delivering instructions for making two key HIV proteins, which are then assembled into virus-like particles that induce immune responses similar to natural HIV infection. NIAID tested the vaccine in mice and rhesus macaques, results of which showed the injections were well-tolerated and elicited immune responses against an HIV-like virus. The research team plans to conduct a phase 1 trial of the novel mRNA HIV vaccine in healthy adult volunteers after further refinement and testing.Researchers at UCLA have made progress in efforts to develop a cure for HIV by targeting infected cells that could be lying dormant in the body, according to a study published in Nature Communications last week. In the new study, researchers built upon a method originally developed in 2017 to kill hidden HIV-infected cells using cells that are naturally produced by the body’s immune system. The study used the “kick and kill” strategy, with researchers first administering a compound to flush out hidden HIV-infected cells, then injecting natural killer cells into a mice’s bloodstream. This cleared HIV completely in 40 percent of infected mice, showing proof of concept for a therapeutic approach to potentially eliminate HIV from the body. Researchers say they now hope to develop an approach that eliminates HIV in 100 percent of tested mice via further experiments and move toward preclinical studies.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email.Novavax has completed submission of the final data package for its COVID-19 vaccine to fulfill the prerequisites for an emergency use authorization (EUA) request from the US Food and Drug Administration. The company plans to complete an official EUA application by the end of the month. The vaccine, NVX-CoV2373, received emergency use listing from the World Health Organization last month for its formulations manufactured in Europe and India, allowing Novavax and partner Serum Institute of India to ship doses to the COVAX initiative, which aims to supply vaccines to low- and middle-income countries. NVX-CoV2373 was also granted conditional marketing authorization in December by the European Medicines Agency to be produced in Europe. Novavax expects its global supply chain to exceed 2 billion doses in 2022.A new COVID-19 vaccine developed by researchers from the Texas Children’s Hospital and Baylor College of Medicine is being offered patent-free to vaccine manufacturers around the world. The CORBEVAX vaccine—originally developed to combat SARS, which is caused by a strain of coronavirus—employs a long-established protein subunit technology that uses proteins from a virus or bacterium to induce an immune response but not cause disease. Clinical trials conducted in India found the vaccine to be 90 percent effective in preventing disease caused by the original COVID-19 virus strain and 80 percent effective against the delta variant, leading India’s regulatory agency to grant emergency use authorization in December. Indian vaccine manufacturer Biological E Limited has sold 300 million doses to the Indian government and plans to produce 100 million doses per month.Dolutegravir-based antiretroviral therapy (ART) is more effective than standard treatments for HIV-positive children, reducing treatment failure by 40 percent, according to a new study published in The New England Journal of Medicine. The clinical trial, conducted at 29 clinical centers across Africa, Europe, and Asia, evaluated the safety and efficacy of dolutegravir-based ART as a first- or second-line treatment in children living with HIV in comparison to non-dolutegravir-based, standard-care ART. Results showed the dolutegravir-based ART reduced treatment failure by 40 percent in HIV-positive children 3 to 18 years old, indicating dolutegravir-based ART is superior to current standard-care treatment in children and adolescents living with HIV, according to researchers.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email.On Thursday, AstraZeneca and Regeneron reported data on the effectiveness of their COVID-19 antibody treatments against the omicron variant of the virus. Regeneron’s therapy, REGEN-COV, is less effective against omicron, though is still active against the delta variant, confirming indications from lab tests and computer modelling late last month. AstraZeneca’s antibody cocktail, Evusheld, retained neutralizing activity against omicron, according to the lab study results. Earlier last week, researchers also announced that Eli Lilly’s antibody treatment lost effectiveness against omicron in lab tests, while GSK-Vir Biotechnology’s antibody treatment retained neutralizing activity against all tested coronavirus variants, including omicron. The omicron variant has been detected in 77 countries since it was first identified three weeks ago, driving concerns that its large number of mutations could help it evade protection by COVID-19 vaccines and therapeutics.A new needle-free COVID-19 vaccine to protect against future virus variants is being tested in the United Kingdom, researchers announced last week. The DIOS-CoVax vaccine, developed by scientists at Cambridge University, is administered through spring-powered jet injection and uses predictive methods to mimic the wider family of coronavirus antigens with the goal of providing more protection than existing vaccines. The trial, which will include participants aged 18 to 50, is a first step toward a universal coronavirus vaccine to protect people from COVID-19 variants and future coronaviruses—a vital part of next-generation vaccine candidates to help protect the world from the next virus threats, according to a researcher involved in its development.An antimalarial drug in development by Zydus Cadila in partnership with the Medicines for Malaria Venture received orphan drug designation from the US Food and Drug Administration (FDA) on Thursday. The designation makes the drug eligible for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions, and seven-year marketing exclusivity upon FDA approval. The drug, ZY19489, is a novel antimalarial compound that combats all current clinical strains of P. falciparum and P. vivax malaria, including drug-resistant strains. A phase 1 study indicated the drug has a long half-life and potential as a single-dose cure for malaria.