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Bayer’s phase 3 study of Nubeqa (darolutamide) in combination with androgen-deprivation therapy (ADT) and docetaxel for patients with metastatic hormone-sensitive prostate cancer has hit its primary endpoint, showing that the combo improved overall survival compared to docetaxel and ADT alone. Read More
Novavax is throwing two punches at Omicron, the new COVID-19 variant that’s sparking fresh waves of travel restrictions: evaluating how well its lead COVID-19 vaccine candidate NVX-CoV2373 targets the new variant and creating a new vaccine made specifically to target the highly mutated virus. Read More
The single-armed study tested mirvetuximab in 106 patients with platinum-resistant high-grade epithelial ovarian, primary peritoneal or fallopian tube cancer. Read More
The FDA has lifted the clinical hold it placed in 2019 on the research and development of Entolimod for acute radiation syndrome (ARS), allowing new owner Statera Biopharma to proceed with plans to look at the molecule in cancer patients. Read More
GlaxoSmithKline (GSK), whose COVID-19 vaccine development efforts have lagged behind those of competitors, has hired away one of the top scientists behind the Pfizer COVID-19 jab, which has been the most ubiquitous of the three vaccines approved for use in the U.S. Read More
Armed with strong results from a late-stage clinical trial, ImmunoGen plans to submit a new Biologics License Application (BLA) for its drug/antibody conjugate Mirvetuximab (mirvetuximab soravtansine) as a treatment for women with folate receptor alpha (FRα)-high platinum-resistant ovarian cancer who have been previously treated with Roche’s Avastin (bevacizumab). Read More
The FDA has placed a clinical hold on Ocugen’s Investigational New Drug (IND) application for BBV152, the company’s COVID-19 vaccine candidate known as Covaxin outside the U.S. Read More