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 treatment but will be paired with another monoclonal antibody known as etesevimab.

The combination of bamlanivimab and etesevimab won EUA status on Feb. 9 to treat mild to moderate COVID-19. The combination is more effective against emerging SARS-CoV-2 variants than either antibody alone.

FDA has indicated the combination of bamlanivimab and etesevimab for people 12 years of age and older who tested positive for SARS-CoV-2. To receive the drugs, patients must weigh at least 40 kg (88 pounds) and have a high risk of developing severe COVID-19 or hospitalization.

Some 400,…

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AbCellera sees its revenue jump 1,908% in 2020

AbCellera Biologics, Inc logo

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, demonstrating strong growth across every area of the business and the effectiveness of our technology and business model through our discovery of the first monoclonal antibody therapy for COVID-19,” said Carl Hansen, AbCellera president and CEO, in a statement.

AbCellera was instrumental in developing bamlanivimab (LY-CoV555), an investigational monoclonal antibody that Eli Lilly eventually co-developed and manufactured. Bamlanivimab was the first antibody from AbCellera to be commercialized. The company now has 103 di…

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