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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 World Health Organization (WHO) awarded the first prequalification to an African-manufactured antimalarial drug used to prevention infection in pregnant women and infants. The medicine, sulfadoxine-pyrimethamine, marketed as Wiwal, is made by Kenyan drug company Universal Corporation Limited. The approval is a step toward strengthening local production of medicines, as well as addressing the disproportionate burden of malaria in Africa.An Oxford University research team announced their new PLATINUM trial assessing whether SIGA Technologies’ tecovirimat (Tpoxx) is an effective treatment for monkeypox. The study seeks to recruit at least 500 participants, who will be given a 14-day treatment of two doses daily or a placebo. Tpoxx has been cleared by the United Kingdom and European Union to treat diseases caused by the family of orthopoxvirus that includes smallpox and monkeypox based on studies in animals and healthy humans, though it has only been used in severe cases in Great Britain. In the United States and Canada, the drug has only been approved to treat smallpox. There have been no studies assessing the effectiveness of the drug in hastening recovery in those infected with monkeypox.Moderna announced that it has requested emergency approval from the US Food and Drug Administration (FDA) for its variant-updated COVID-19 vaccine. The vaccine is a booster dose for adults 18 years and older targeting Omicron subvariants B.A.4 and B.A.5. If approved, doses could be ready to ship in September. Moderna’s announcement follows Pfizer and BioNTech’s news that they have applied for FDA approval for their updated booster.

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 Project to Accelerate New Treatments for Tuberculosis (PAN-TB) announced a joint development agreement to support phase 2 trials evaluating two investigational combination treatment regimens for active pulmonary tuberculosis (TB). Both regimens combine already registered products with new chemical entities (NCEs). The first combines delamanid and bedaquiline with two NCEs, OPC-167832 and sutezolid, while the second includes pretomanid and bedaquiline with the two NCEs. The trials will test whether these regimens can substantially shorten treatment duration, with the goal of advancing a suitable regimen into phase 3 development. UNICEF has awarded GSK a contract valued at up to US$170 million to produce the first malaria vaccine. The award will pay for 18 million doses of GSK’s RTS,S vaccine over the next three years. UNICEF has stated their hopes that the award will encourage other malaria vaccine developers to continue to innovate new technologies in order to address the burden of malaria, especially to mitigate preventable deaths of children under five years old from the disease. The United Nations agency expects high demand for the vaccine and believes that costs per dose will decrease over time as supply and manufacturing capacity grow in turn.On Monday, August 15, the UK Medicines and Healthcare products Regulatory Agency (MHRA) gave conditional approval to Moderna’s Omicron variant-updated COVID-19 vaccine for use as a booster in adults. The approval is based on clinical data that demonstrated “strong immune response” against the original virus and B.A.1 subvariant and exploratory analysis showing a “good immune response” against the B.A.4 and B.A.5 subvariants as well as no serious safety concerns. The UK’s Joint Committee on Vaccination and Immunisation followed by supporting the use of the updated vaccine the national booster shot campaign starting next month.