Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adhera, Hillevax, J&J, Melior, Neopharm, NRG, Protagonist, Rhythm, Siga, Takeda, Urogen, Zandcell.
Novavax Inc. now says it plans to submit an emergency use authorization (EUA) to the FDA for its highly efficacious COVID-19 vaccine, NVX-CoV2373, sometime in the fourth quarter, backing off previous plans of a second-quarter and then a third-quarter filing.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Becton Dickinson, Certest Biotech.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apexigen, China Pharma, Eiger, Everest, Exelixis, Merck, Therapeutic Solutions.
Preliminary real-world data showed that Chinese inactivated vaccines are 63% protective against the COVID-19 Delta variant, China’s top epidemiologist Zhong Nanshan said at the 24th Respiratory Disease Academic Conference of Guangdong Medical Association in Guangzhou.
Investigators at the University of California at San Francisco have identified a confounder that appears to be behind the purported anti-SARS-CoV-2 effects of a number of therapeutic candidates that were identified via repurposing.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Insightrx, Ortho Clinical, Pillar, Zoll.