Bharat Biotech International Ltd. has successfully developed India’s first indigenous vaccine candidate for COVID-19 to enter human trials. Named Covaxin, the vaccine has been cleared by the Drug Controller General of India (DCGI) and Ministry of Health & Family Welfare for phase I and II trials after the company submitted positive preclinical study results regarding safety and immune response.
Corvus Pharmaceuticals Inc.’s success in treating a COVID-19 patient previously diagnosed with non-small-cell lung cancer (NSCLC) with CPI-006 helped boost shares (NASDAQ:CRVS) to $4.96, up $2.21, or 181%, as the Burlingame, Calif.-based company disclosed the start of a phase I study to investigate the anti-CD73 immunotherapy prospect.
Missing the primary endpoint along with key secondary endpoints in a phase III trial of Kevzara (sarilumab), an interleukin-6 (IL-6) receptor antibody, for treating COVID-19 patients who need mechanical ventilation caused Regeneron Pharmaceuticals Inc. and Sanofi SA to halt the study.
DUBLIN – Idorsia Ltd. plans to file an NDA before the year-end for its insomnia drug, daridorexant, following a read-out of top-line data from a second phase III study, which the company said closely tracked an earlier phase III study, although it failed to meet one of two primary endpoints with statistical significance.