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Pandemic Perspectives: Veklury’s Clinical Development Timeline Compressed By Collaborative Review, Previous Research

 
• By Bridget Silverman

Just five and half years elapsed between Gilead’s first remdesivir IND for Ebola virus and Veklury’s US FDA approval for COVID-19.

The exigencies of the COVID-19 pandemic have driven unprecedented cooperation and creativity in drug development and regulation, but only one therapy for patients infected with SARS-CoV-2 has reached the milestone of US FDA approval as a traditional NDA as well as under emergency use authorization: Gilead Sciences, Inc.’s Veklury (remdesivir). FDA review documents show how the agency used its existing regulatory authorities, especially the fast track designation, to condense clinical and review processes – while at the same time, the World Health Organization was sponsoring its own trial, resulting in conflicting recommendations from two of the world’s foremost health authorities.

Pandemic Perspectives

One year on from the World Health Organization declaring COVID-19 a global pandemic on 11 March 2020, editors across Informa Pharma Intelligence publications are taking a closer look at its impact and possible lasting implications for the biopharma and medtech industry.

Thanks to earlier research against Ebola virus disease and the SARS and MERS coronaviruses, remdesivir was identified early on as...

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Potency Assay Issues Delayed US FDA Approval Of Mesoblast’s Ryoncil For Years

 
• By Sue Sutter

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Mesoblast’s Ryoncil: US FDA Changed Its Mind On Need For A Randomized Trial

 
• By Sue Sutter

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Ryoncil Chronology: Three Review Cycles, Two CRLs, One Dispute Resolution Request

 
• By Sue Sutter

The Pink Sheet’s Drug Review Profile looks at the timeline for the clinical development and US FDA review of Mesoblast’s remestemcel for graft-versus-host disease.

Testosterone, TRAVERSE, And A Label Change 15 Years In The Making

 
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New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.

US FDA Meeting Drought Ends … With A Vengeance

 
• By Michael McCaughan

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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.