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Private Company Edition: TVM, Focus/MD Anderson and RA Capital launched new venture capital funds. Also, LianBio’s $310m crossover financing, AavantiBio’s Sarepta-backed $107m series A and Sirnaomics’ $105m series D led recent VC rounds.
Gilead's remdesivir is first drug fully approved by FDA to treat COVID-19. Roche and Atea team up on an investigational direct acting antiviral while Moderna reaches the 30,000-patient enrollment target for its Phase III COVE study of the company's investigational mRNA vaccine.
The US FDA heard a lot about the structural, medical and especially financial barriers facing coccidioidomycosis, or Valley fever, drug development soon after the agency refused to qualify the rare fungal infection for priority review voucher incentives.
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.
- Other Names / Subsidiaries
- BioGeneriX AG
- Neose Technologies, Inc.