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Latest From ratiopharm

Coronavirus Update: Gilead's Veklury Gets Full FDA Approval, Roche Partners With Atea

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. 

Coronavirus COVID-19 Vaccines

Coccidioidomycosis Outlook Highlights The Limits Of Regulatory Incentives

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.

Rare Diseases Review Pathway

Antifungal Drug Sponsors Seek Clearer Regulatory Pathway, Less Burdensome Trials

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.

Clinical Trials Rare Diseases

Coronavirus Update: Japan Makes Moves On Vaccine Manufacturing

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.

Coronavirus COVID-19 Clinical Trials
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    • BioGeneriX AG
    • Neose Technologies, Inc.
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