The FDA will allow the use of Lilly’s (NYSE:LLY) bamlanivimab and etesevimab antibodies for younger pediatric patients, including newborns. The revised expanded emergency use authorization (EUA) specifically includes children with mild-to-moderate COVID-19 who face a high risk of disease progression. The EUA previously covered children at least 12 years of age who weigh at least…
HHS pauses use of Lilly’s COVID-19 antibody cocktail in several states
The U.S. Department of Health and Human Services (HHS) has recommended pausing the combination of Eli Lilly’s (NYSE:LLY) bamlanivimab/etesevimab in eight states, including Illinois, Massachusetts, Arizona, California, Florida, Indiana, Oregon and Washington. The agency’s reasoning for the decision is grounded in lab data that found the antibody cocktail is not effective against P.1 (Brazilian) or B.1.351…
FDA nixes EUA for Lilly’s bamlanivimab
On April 16, Lilly announced that it was requesting FDA to revoke the emergency use authorization (EUA) for the monoclonal antibody bamlanivimab (LY-CoV555) when used alone. Hours after, the agency agreed to rescind the EUA on the grounds that bamlanivimab is potentially ineffective against some SARS-CoV-2 variants. Bamlanivimab, however, won’t be disappearing as a COVID-19…
AbCellera sees its revenue jump 1,908% in 2020
Biotech firm AbCellera (NASDAQ:ABCL) announced its full-year 2020 business results, which were dramatically higher than the previous year. The company pulled in $233 million in total revenue last year compared with $11.6 million in 2019. Net earnings for 2020 were $119 million compared to a $2 million loss in 2019. “AbCellera had a breakthrough year,…
Lilly’s bamlanivimab and etesevimab cut COVID-19 hospitalization and deaths in study
A recent Phase 3 trial found that Lilly’s bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) administered jointly led to an 87% reduction in hospitalization and deaths in high-risk patients recently diagnosed with COVID-19. The randomized, double-blind, placebo-controlled trial administered 700 mg of bamlanivimab (LY-CoV555) and 1400 mg of etesevimab (LY-CoV016) to 511 patients in the treatment arm.…
Lilly and UnitedHealth team up on bamlanivimab study for COVID-19
Eli Lilly (NYSE:LLY) and UnitedHealth Group (NYSE:UNH) are partnering on a pragmatic study of bamlanivimab (LY-CoV555) in high-risk patients with COVID-19 infections. Lilly recently won emergency use authorization from the FDA to use the monoclonal antibody bamlanivimab to treat mild to moderate COVID-19 infections in patients at risk of severe infections. The study will evaluate the…
NIAID halts Lilly COVID-19 antibody study
An arm of NIH has ended a clinical trial investigating the use of Eli Lilly’s (NYSE:LLY) monoclonal antibody LY-CoV555 (bamlanivimab) to treat hospitalized COVID-19 patients. In separate news, HHS plans to allocate 300,000 doses of the monoclonal antibody immediately, according to an announcement. While the drug shows promise in treating mild-to-moderate COVID-19 infections, the ACTIV-3 trial…