Eli Lilly has submitted an application to the US Food and Drug Administration (FDA) seeking emergency use authorisation (EUA) for LY-CoV555 monotherapy for treating higher-risk patients with mild-to-moderate Covid-19. The company also plans to submit an EUA application to the FDA for a combination therapy of LY-CoV555 and LY-CoV016 in November this year. The
Israel-based Mapi Pharma has commissioned a vaccine production facility to support the supply of vaccines against Covid-19 to the country, as well as Europe and other global markets. The company is expanding its Jerusalem Fill & Finish plant with an investment of more than $100m. It will add a new line for sterile filling and finishing of liquids and powders for injections.
The Native Antigen Company has launched ten new monoclonal antibodies that identify different epitopes of the SARS-CoV-2 Spike glycoprotein. Nine of these candidates specifically detect SARS-CoV-2 and do not do not cross-react with other human coronaviruses, the company said. These antibodies could help in the research and development of Covid-19 vaccines, therapies and diagnostics.
India’s regulator agency has declined a proposal from Dr Reddy’s Laboratories to conduct a large-scale study of Russia’s Sputnik-V Covid-19 vaccine. A panel of the Central Drugs Standard Control Organisation (CDSCO) asked for a smaller trial, stating that safety and immunogenicity data available from early-stage studies overseas is small, without any inputs on Indian subjects. Meanwhile, the Indian Council of Medical Research (ICMR) secured approval to trial animal-derived antibodies for treating Covid-19.
Amid shortages in Europe, the European Commission has agreed to purchase more doses of Gilead Sciences’ remdesivir to treat approximately 3,400 patients, reported Reuters. This comes after the agency purchased 30,000 courses of the treatment in July that were meant to cover Europe’s requirement in August and September. However, with increasing cases and hospitalisations across the continent, several countries are facing shortages of the drug.