- Aimed at facilitating nationwide access to antibody-rich blood products for COVID-19 patients, the FDA has instituted an emergency investigational new drug application (eIND) process for convalescent plasma, with its SARS-CoV-2 antibodies, collected from people who have recovered from the infection.
- Based on prior history with respiratory viruses and data from China, convalescent plasma and its more refined relative, hyperimmune globulin (concentrated SARS-CoV-2 antibodies), may shorten the recovery time for severely ill patients.
- The agency says it has provided information to healthcare providers on how to submit applications for clinical studies at academic institutions.
- The Mayo Clinic will serve as lead institution while the American Red Cross will help with plasma collection and distribution.
- Selected tickers: Emergent BioSolutions (EBS +1.4%), ADMA Biologics (ADMA +8.5%), Kamada Ltd. (KMDA), XBiotech (XBIT +5.0%)
Read original article here.