Coronavirus Update: Pfizer Vaccine Candidates Gain Fast-Track Status
Two mRNA Candidates Selected
The granting of fast-track status is a clear signal that the US FDA wants to maintain its high standards of drug and vaccine appraisal.
You may also be interested in...
With a proposed IPO, Gland Pharma’s parent company, Fosun Pharma, hopes to raise funds for its injectables business and possibly its COVID-19 vaccine. The move will also cut Chinese ownership against a backdrop of shaky relations between India and China. As investors warm up to pharma stocks, the timing seems right.
FDA should have all coronavirus vaccines evaluated by Vaccines and Related Biological Products Advisory Committee before approval, Democratic senators and representatives say; House subcommittee also wants FDA to require 30,000 participants in Phase III trials.
Biocon’s itolizumab gets clearance in India for restricted emergency use in COVID-19 patients, amid some concerns around small study numbers. But company says data are compelling and cites compassionate use substantiation, while partner Equillium expects to pursue a global study under US IND.