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More Remdesivir Data, More Questions Linger

 
• By Derrick Gingery

The latest data on the NIAID’s ACTT-1 study offers more help for clinicians trying to determine which coronavirus patients should receive remdesivir, but selection criteria – and supply – remain uncertain.

Coronavirus
Clinicians have some clues about the best patients for remdesivir, but say more information still is needed after studies were published. • Source: Shutterstock

Additional positive clinical data about Gilead Sciences Inc.’s remdesivir in coronavirus disease was welcome news for clinicians, but may only answer a few of the many questions about the optimal use of the antiviral.

The New England Journal of Medicine on 22 May published a preliminary report with remdesivir data from the placebo-controlled ACTT-1...

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Post-Approval, Real-Time Monitoring Will Help Approval Standards, US FDA’s Makary Says

 
• By Sue Sutter

The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.

EU Tests Unified Pathway For Combined Drug/IVD Studies

 
• By Vibha Sharma

The EU is testing a groundbreaking “all-in-one” process for reviewing combined drug and diagnostic trials via a single application for coordinated assessment.

UK-Wide Strategy Needed To Move Clinical Trial Diversity Plans To Next Stage

 
• By Vibha Sharma

The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.

Trial Cancellations And Delays Persist For CROs Amid Biotech Slowdown

 
• By Vibha Sharma

The whole contract research organization industry is being impacted by the current volatility in the pharmaceutical industry.

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