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Stem Cells For COVID-19: Promising Platform With A ‘Dark Side’

 
• By Bridget Silverman

Mesenchymal stem cells have encouraging early data in ARDS, but the stem cell industry’s shady reputation complicates perception – and trial enrollment.

Stem Cells, 3D rendering. - Illustration

The COVID-19 crisis could be a proving ground to legitimate the still early-stage technology of mesenchymal stem cell therapy, but only if clinical trials are of high quality – blinded and randomized – in a context of regulatory clarity.

“I don’t know that we need more trials,” leading MSC researcher Michael Matthay, University of California San Francisco, said during...

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More from Cell & Gene Therapies

Ultragenyx Says CRL Discussions ‘Productive’ Despite US FDA Leadership Upheaval

 
• By Jessica Merrill

Ultragenyx said talks with the FDA about a path forward after receiving a CRL for UX111 have been productive despite the recent upheaval at the agency.

Prasad 2.0 Brings New Instability Concerns, Questions About Changed Regulatory Philosophy

 
• By Sarah Karlin-Smith

Many agency stakeholders believe Vinay Prasad may be forced to change his regulatory approach at least somewhat after receiving a second chance to lead the US FDA's biologics center.

Double Duty At US FDA: Tidmarsh Will Temporarily Lead Both CDER And CBER

 
• By Sarah Karlin-Smith

Just a week and a half into his tenure at the agency, the new CDER Director George Tidmarsh was also tapped to serve as acting head of CBER. Prasad’s swift ouster at CBER may point to a softening in cell and gene therapy regulation but could also portend even more scrutiny on vaccines.

Vinay Prasad Out At US FDA

 
• By Sarah Karlin-Smith

The removal of CBER Director Prasad comes after a wave of right-wing backlash to his appointment over the past few days that was also critical of his decision to ask Sarepta to suspend all sales of the DMD gene therapy Elevidys. FDA reversed its decision the day before Parsad's departure.

More from Advanced Technologies

Generic Drugs And AI: Maximum Daily Dose Tool Could Help US FDA Be ‘At The Forefront’

 
• By Michael McCaughan

The FDA is testing a new artificial intelligence tool to help generic drug developers automate maximum daily dose calculations.

Double Duty At US FDA: Tidmarsh Will Temporarily Lead Both CDER And CBER

 
• By Sarah Karlin-Smith

Just a week and a half into his tenure at the agency, the new CDER Director George Tidmarsh was also tapped to serve as acting head of CBER. Prasad’s swift ouster at CBER may point to a softening in cell and gene therapy regulation but could also portend even more scrutiny on vaccines.

Vinay Prasad Out At US FDA

 
• By Sarah Karlin-Smith

The removal of CBER Director Prasad comes after a wave of right-wing backlash to his appointment over the past few days that was also critical of his decision to ask Sarepta to suspend all sales of the DMD gene therapy Elevidys. FDA reversed its decision the day before Parsad's departure.