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Latest From Amplyx Pharmaceuticals
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.
Private Company Edition: Atea and Phlow receive big money for big COVID-19 problems – treatments and manufacturing capacity. Also, Cowen raises a $493m fund and antifungal developer Amplyx increases series C round to $90m, among other recent VC deals.
Dermatology-focused regenerative medicine firm Fibrocell has been reviewing strategic opportunities for more than a year; April’s FCX-007 license deal with Castle Creek results in buyout.
Fosmanogepix, with safety and efficacy clearances to continue Phase II, could provide an IV-to-oral option for patients with potentially lethal Candida fungal infections.
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