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Gilead hit with FDA clinical hold for batch of HIV trials

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has placed a clinical hold on several of Gilead’s trials evaluating two HIV treatment candidates, though the rest of the drugmaker’s diverse pipeline remains unaffected. Gilead is considered the leading big pharma in HIV treatments. Shares in Nasdaq-listed Gilead opened 0.3%

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Oral COVID Agents

Pharmacy Friday Pearls

18 years Administration Oral Oral Oral PK/PD MOA: Nirmatrelvir – inhibitor of the SARS-CoV-2 main protease Prevents viral replicationRitonavir is a CYP3A inhibitor included to increase nirmatrelvir plasma levelsRitonavir alone has NO activity against SARS-CoV-2 Time to peak: Nirmatrelvir: 3 hrs & Ritonavir: 3.98 Introduction.

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Agile, Data-Driven Life Cycle Management for Continuous Manufacturing

ISPE

1 , 4 A Retrospective Journey In 2015, Vertex’s Orkambi was the first approved drug produced under a CM process for the treatment of cystic fibrosis. Table 1: List of FDA-approved commercial products using CM elements. Table 1: List of FDA-approved commercial products using CM elements. This is demonstrated by the rise from $1.05