FDA experts want to see more ABthrax data

A panel of FDA experts says that Human Genome Sciences should provide more data on how its anthrax drug ABthrax stacks up against the antibiotics already available for treatment. HGS's studies underscored the effectiveness of antibiotics alone, raising questions about the need for adding ABthrax to the mix. The panel also voted 16 to 7 that HGS's data collected in animal studies offered a reliable guide to how the therapy would work in humans. The FDA said on Monday that it had questions about the reliability of HGS's ABthrax data and didn't ask the panel to decide whether or not the drug should be approved. Report

Suggested Articles

After delivering a "positive surprise" in December, Biogen is painting a fuller picture of its lupus drug.

A new CRISPR technique neutralizes SARS-CoV-2 by scrambling the virus' genetic code. It could prove useful for fighting other viruses, like influenza.

The deal, which follows a bidding war with AcelRx, gives Melinta another approved antibiotic and potentially complementary R&D expertise.