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Warp Speed’s Woodcock Encourages Institutions To Continue COVID-19 Plasma Controlled Trial

 
• By Brenda Sandburg

Seeking to prevent negative fallout from emergency use authorization, Woodcock and NIH Director Collins ask investigators to prioritize a controlled trial of convalescent plasma currently underway in outpatients.

Coronavirus COVID-19 medical test vaccine research and development concept. Scientist in laboratory study and analyze scientific sample of Coronavirus antibody to produce drug treatment for COVID-19.
Government officials encourage investigators to prioritize a COVID-19 convalescent plasma trial • Source: Shutterstock

Operation Warp Speed’s Janet Woodcock and National Institutes of Health Director Francis Collins are trying to prevent the US Food and Drug Administration’s emergency use authorization of COVID-19 convalescent plasma from having a negative impact on an ongoing randomized controlled trial in outpatients.

In an usual move, Woodcock, who is on temporary leave as director of FDA’s Center for Drug Evaluation and Research, and Collins posted a letter on the trial’s website on 27 August asking clinical investigators, trial staff and institutional leadership supporting the study to give it high priority

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US FDA Rare Disease Case Studies Provide Development Models For Sponsors

 
• By Laura Helbling

Sanofi’s Xenpozyme and Sentynyl’s Nulibry are the first two case studies the FDA is using to continue educating rare disease sponsors on best practices.

UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 
• By Anabel Costa-Ferreira

Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.

EU Health Data Space May Speed Up R&D Through Access To Multi-Omics & Clinical Record Data

 
• By Eliza Slawther

The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.

What The EMA Can Teach HTA Bodies About Joint Clinical Assessments

 
• By Francesca Bruce

EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.

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US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped

 
• By Derrick Gingery

Cuts to the FDA’s policy and legal personnel have prevented dozens of product-specific guidances for generic drug development from being published.

Unlocking Opportunities: How To Engage With The EMA On Animal Testing Alternatives

 
• By Neena Brizmohun

The European Medicines Agency, like its counterpart in the US, is increasingly focusing on the use of alternatives to animal testing.

EU Pharma Reform: Exclusivity Vouchers Alone Are Insufficient Incentive For Antimicrobials, Industry Says

 
• By Eliza Slawther

European pharma trade associations EFPIA and EUCOPE outline their respective views on how the EU’s pharma legislation overhaul should tackle antimicrobial resistance, and why transferable exclusivity vouchers alone will not suffice as incentives.