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CytoDyn’s Promotion Of Investigational Drug Leronlimab Once Again Rebuked By US FDA

 
• By Brenda Sandburg

OPDP warning letter objects to video interview in which CytoDyn's then CEO touts use of the investigational drug for COVID-19. The exec says he is ‘making up numbers’ but if the pattern continues there will be ‘the most fantastic results’ anybody could ever imagine.

Monoclonal antibody
CytoDyn video promotion for its investigational COVID-19 treatment draws FDA warning letter • Source: Alamy

For the second time in a year, the US Food and Drug Administration has reprimanded CytoDyn, Inc. for making claims about the efficacy of its investigational drug leronlimab for treatment of COVID-19. The agency went further this time, with the Office of Prescription Drug Promotion issuing a warning letter to the company demanding that it submit a plan to disseminate a corrective communication.

In a 11 February letter, OPDP objected to a video interview in which then CytoDyn president and CEO Nader...

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EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

AI In Clinical Research: Benefits Across The Board, But ‘Nirvana’ Still Out Of Reach

 
• By Vibha Sharma

Generative artificial intelligence tools, such as ChatGPT, have “democratized” AI, and contract research organizations are wholeheartedly embracing these tools, given their focus on efficiency, says Stephen Pyke, who chairs the AI committee at the Association of Clinical Research Organizations.

Japan Gives Global-First Recommendations To Taisho’s Vornorexant, Santen’s Sepetaprost

 
• By Lisa Takagi

Japan gives world-first approval recommendations to two domestically originated drugs, for insomnia and glaucoma/ocular hypertension.