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Latest From Equillium, Inc.
Biocon chair believes new perspectives on regulatory science and processes emerging from the US's "Warp Speed" efforts to accelerate COVID-19 vaccines have potential for wider application, although Regeneron's president urges caution around relying only on small studies to advance repurposed drugs.
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.
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.
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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