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Regenerative Medicines Provisions Of Cures Act A Top Priority For CBER

 
• By Michael Cipriano

CBER Director Peter Marks says center will mobilize necessary resources to make sure these provisions are implemented; Marks also offered comments in opposition to 'right-to-try' legislation.

FDA entrance sign 2016

Regardless of the uncertainty surrounding the upcoming budget and user fee negotiations, the Center for Biologics Evaluation and Research (CBER) will make the implementation of the 21st Century Cures Act's regenerative medicines provisions a major priority, center Director Peter Marks says.

"At the moment, we are reasonably well-resourced … I think just as Dr

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Tougher Approval Standards May Follow Vinay Prasad’s Appointment To Lead US FDA’s CBER

 
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Industry is concerned that Prasad may make regulatory flexibility tougher to obtain for cell and gene therapy, while vaccine and public health advocates are angry about Prasad’s criticisms of US COVID-19 policies.

Sponsors Like START Rare Disease Pilot, Will Prasad Maintain Its Momentum?

 
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Sponsors reported faster development times for products that joined the pilot program intended to speed rare disease treatments in CBER.

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

 
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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

Agency staff repeatedly said the BLA based on a single-arm study in 55 patients lacked substantial evidence of effectiveness in steroid-refractory acute graft-versus-host disease and a randomized trial was needed, but changed course “based on additional consideration” after a second CRL.

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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

 
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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.