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Latest From F2G Ltd
Having banked a $100m upfront fee from licensing partner Shionogi a couple of months ago, F2G has now unveiled a $70m financing to advance its late-stage novel oral antifungal, olorofim.
Astellas subsidiary Xyphos will partner with GO to discover novel antibodies against two glycoprotein targets. SciNeuro picks up abandoned GSK programs in cardiovascular medicine for potential use in the neurodegeneration space.
Accelerated approval might soon be in the cards for COVID-19 vaccines if an immune correlate of protection can be identified through ongoing work by FDA and NIH. Meanwhile, to speed more vaccines to Americans, FDA is trying to help ramp up manufacturing. Sanofi is set to commence a Phase IIb trial with an active comparator.
Citing difficulties in conducting randomized trials, industry speakers call for a new way of thinking about the US FDA's substantial evidence standard for antifungal approvals under the LPAD route, as well as revisions to enrollment criteria and study endpoints.
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