In a roundup of some of the latest scientific studies on the novel coronavirus and efforts to find treatments and vaccines for Covid-19, researchers found when a new monoclonal antibody drug was added to treatments being given to hospitalized Covid-19 patients who were still breathing on their own, Humanigen Inc.’s lenzilumab significantly improved their odds of not needing invasive mechanical ventilation.
The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee did not agree in a meeting to maintain the accelerated approval of Bristol Myers Squibb’s Opdivo (nivolumab) as a second-line treatment of hepatocellular carcinoma.
Roche culled two more Phase II Covid-19 programs, as announced in the Swiss pharma giant’s first-quarter 2021 financial report.
GSK and Vir Biotechnology filed an application to U.S. regulators for emergency use authorization of their antibody therapy to treat early-stage Covid-19 infections, the drugmakers said on March 26.
Europe’s drug regulator said on March 11 it had initiated a rolling review of U.S.-based Eli Lilly’s antibodies to treat Covid-19, days after saying their combination could be used in patients at high risk of progressing to severe illness.
Newly announced data from Eli Lilly’s Phase III BLAZE-1 clinical trial show a combination of two of the company’s monoclonal antibodies, bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016), significantly reduced the risk of hospitalization and death in high-risk patients with newly diagnosed coronavirus disease 2019.
Novartis’ drug canakinumab (ACZ885) did not meet the primary endpoint of overall survival in patients with advanced or metastatic non-small cell lung cancer in a Phase III study, but other late-stage trials are ongoing.
Vir Biotechnology and Britain’s GlaxoSmithKline said on March 3 they would pause enrollment into a study testing their experimental Covid-19 antibody therapy, which is a part of a large U.S. trial.
Europe’s drug regulator is evaluating South Korean drugmaker Celltrion’s Covid-19 antibody treatment, the third such drug against the disease to go under real-time review in the region.
Regeneron and Sanofi’s checkpoint inhibitor Libtayo (cemiplimab-rwlc) won U.S. Food and Drug Administration approval for the first-line treatment of patients with advanced non-small cell lung cancer whose tumors have high PD-L1 expression.
