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Gilead files COVID-19 drug remdesivir with FDA

pharmaphorum

Gilead has filed its COVID-19 drug remdesivir with the FDA, to treat patients with severe disease, under the brand name Veklury. Originally intended as a treatment for Ebola virus, Veklury is a nucleotide analogue with broad-spectrum antiviral activity both in vitro and in vivo in animal models against several emerging viruses.

Drugs 99
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Transitioning Between Academia and Industry: Advice from Leading Scientists That Made the Switch

XTalks

Leaving academia for industry is a route that academic scientists and professors did not traditionally pursue in the past due to perceived differences in skillsets, experiences and even associated stigmas. However, this has since changed, and now, transitioning between academia and industry has become more commonplace. Key Moments.

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Using FDA Product Specific Guidances (PSGs) as a Trigger for Generic Drug Development

Drug Patent Watch

These guidances serve as a roadmap for companies looking to develop generic versions of brand-name drugs, offering invaluable insights into the FDA’s expectations for demonstrating bioequivalence and ensuring product quality. They provide recommendations on the design of in vitro and in vivo studies.