Human Genome Sciences / GlaxoSmithKline
On 5/21/09, Human Genome Sciences (NASDAQ:HGSI) announced that it submitted a Biologics License Application (BLA) to the FDA for its human monoclonal antibody drug ABthrax (raxibacumab) for the treatment of inhalation anthrax. Raxibacumab is a first-in-class treatment for anthrax, and is being developed under a contract entered into in 2006 with the Biomedical Advanced Research and Development Authority of the Office of the Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services (HHS).
On 6/11/09, HGSI announced Phase 2 continuation data which demonstrated sustained improvement in disease activity and patient response rate through four years of BENLYSTA therapy in combination with standard of care in patients with serologically active systemic lupus erythematosus (SLE). The frequency of disease flares as measured by the SELENA SLEDAI flare index and by BILAG A or B organ domain scores decreased over four years of BENLYSTA therapy and there was no increase in overall adverse events, serious adverse events, malignancies or serious infections over time. HGSI and GlaxoSmithKline (NYSE:GSK) have selected BENLYSTA as the brand name for belimumab (formerly known as LymphoStat-B).
HGS and GSK expect to report the first Phase 3 data for BENLYSTA in July 2009 from the BLISS-52 trial, with results from BLISS-76 anticipated in November 2009.
BLISS-52 and BLISS-76 are the largest clinical trials ever conducted in lupus patients.
posts are IMHO // either news - with LINK
posts are IMHO // either news - with LINK 
