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.
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With 46 initial public offerings in the US by drug developers so far – including recent launches by Kymera, Inhibrx and Harmony – 2020 will easily beat last year’s 50 IPOs. In follow-on offerings and VC deals, newly public Schrodinger raised $346.5m and Tango’s $50m equity financing.
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.