Just 80 days after first issuing an emergency use authorization (EUA) for oral formulations of chloroquine phosphate (CQ) and hydroxychloroquine sulfate (HCQ) in treating COVID-19, the FDA is revoking that authorization in light of clinical data and scientific literature that raised questions about whether benefits of the treatment outweigh the risks.
BEIJING – Nasdaq-listed Chinese vaccine developer Sinovac Biotech Ltd., of Beijing, said the preliminary results of the phase I/II trials of its COVID-19 inactivated vaccine candidate, Coronavac, demonstrated favorable immunogenicity and safety profiles.
LONDON - The EU has secured a supply of the most advanced COVID-19 vaccine in development, in a deal with Astrazeneca plc for up to 400 million doses of AZD-1222, with deliveries starting by the end of 2020.
LONDON – EU health ministers have given the go-ahead for the European Commission to negotiate COVID-19 vaccines contracts on behalf of all 27 member states, approving the use of a €2.3 billion (US$2.6 billion) emergency fund for down payments.
HONG KONG – Singapore-based Tychan Pte. Ltd. is starting a phase I trial for a novel monoclonal antibody (MAb) that specifically targets SARS-CoV-2, the coronavirus that causes COVID-19. The trial is expected to take only around six weeks to complete.
Due to the pressing challenges of COVID-19, Health Canada is giving drug companies six more months to prepare for major reforms to its 1987 Patented Medicines Regulations.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biophytis, BMS, CNS, Diffusion, Eyegate, Genequantum, Inmune, Intelgenx, Lannett, Leo, Mylan, Novartis, Pfizer.
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