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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.
Takeda has linked up with COVID-19 vaccine frontrunner Novavax, while Daiichi Sankyo has been selected by Japan’s Ministry of Health, Labour and Welfare as an official participant under the first round of a national government initiative to build production capacity.
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- BioGeneriX AG
- Neose Technologies, Inc.