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Pandemic Perspectives: US FDA ACTT’s On Its Faith In Randomized Trials With Veklury Approval Despite WHO Study

 
• By Bridget Silverman

US FDA has not deviated from its bedrock trust in the value of ‘statistically reliable’ endpoints amidst the COVID-19 pandemic, the Pink Sheet’s Drug Review Profile of Gilead’s Veklury shows.

Gilead sign at headquarters. Gilead Sciences announced plans to test a treatment for COVID-19, disease caused by growing coronavirus outbreak - Foster City, California, USA - 2020
• Source: Michael Vi / Shutterstock

The COVID-19 pandemic has highlighted the agency’s regulatory flexibility and ability to adapt to emerging outside data, especially in the review of the only COVID-19 therapy to receive full FDA approval, Gilead Sciences, Inc.’s Veklury (remdesivir).

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.

But the agency’s first principles were also on display when the review team determined that the lack of a mortality...

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

 
• By Sue Sutter

The company’s failure to show its potency assays measured attributes directly related to the mesenchymal stromal cell product’s therapeutic effect highlights the importance of a robust CMC program for complex cell therapies.

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

 
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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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The Pink Sheet drug review profile investigates the long and rigorous process behind the FDA’s recent relaxation of the cardiovascular safety warning for testosterone products.

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EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
• By Eliza Slawther

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

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

The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed quickly.