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.
The U.S. Food and Drug Administration granted Emergency Use Authorization (EUA) to a combination of Eli Lilly and AbCellera’s monoclonal antibody bamlanivimab and the Lilly antibody etesevimab for mild to moderate Covid-19.