U.S. Army seeking approval from FDA to use the monoclonal antibody product for treatment of septic shock in U.S. troops stationed in the Middle East for "Operation Desert Shield." The military has signed an open-ended contract with Centocor to purchase 200 doses of Centoxin, and possibly additional doses, at $2,500 per dose. The company is providing the Army with the information it needs to obtain a special approval (a "combative IND"?) since the drug's approval for marketing in the U.S. is currently pending.
You may also be interested in...
The risk of inadvertently growing SARS-CoV-2 virus in cell and gene therapies and possibly infecting patients and workers should be assessed and mitigated, the agency advises.
Move was meant to preempt others’ efforts to secure the next six months of Regeneron’s COVID-19 antibody therapeutic.
The company is optimistic about a significant portion of eligible patients opting for its newly approved long-acting HIV therapy over daily, oral antiviral therapy.