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Capricor seeks FDA approval of deramiocel for Duchenne based on encouraging data

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Linda Marbán, Capricor

The cell therapy biotech Capricor recently released new data from their Duchenne Muscular Dystrophy (DMD) trial work. The data have generated excitement in the patient advocacy community. The stock has skyrocketed. How exciting are these new data? CEO Linda Marbán is quite upbeat and I think it’s justified. The firm is now seeking FDA approval […]

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FDA’s CBER fires off 3 more warning letters on cellular biologics for a total of 12 in 2024

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Something seems to have dramatically changed with the FDA at its Center for Biologics Evaluation and Research or CBER. Did they start handing out free Red Bull by the case? So many recent FDA warnings on cell and tissue biologics CBER is the part of the FDA that regulates regenerative medicine products like stem cells,

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Big spike in FDA warning letters to unproven biologics firms

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Dr. Peter Marks, Director of CBER, FDA warning

This year already appears to be a record one for cell and tissue therapy-related warning letters the FDA. Directly or indirectly, these come from the FDA’s Center for Biologics Evaluation and Research or CBER. Something unusual seems to be happening. FDA’s CBER has been exceptionally active in 2024 including on cell & tissue products I’ve

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Regener-Eyes maker gets FDA warning on amniotic eye drops

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Regener-Eyes

The FDA alerted the public about issues related to amniotic eye drops last year and now the agency just warned the manufacturer of one such product called Regener-Eyes. The manufacturer is Regenerative Processing Plant, LLC. The warning letter was addressed to its owner, Carl R. Harrell, MD. What’s the deal with this warning? Let’s start

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Weekly reads: stem cell shampoo, Neobiosis FDA warning, trogocytosis

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stem cell shampoo

Even for a stem cell research wonk like me the broader regenerative arena never ceases to surprise me with the latest thing being stem cell shampoo. Stem cell shampoo A news item that seems promotional discussed the stem cell shampoo as yielding positive results. So after you are done with your vampire facelift, stem cell

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Another state challenges FDA on biologics as Nevada OKs risky, unproven oligo, gene, & other therapies

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Julie Pazina, Nevada law biologics

Nevada has a relatively new 2023 law legalizing non-FDA-approved biological and gene therapies. I use the word “therapies” here loosely.  They are not scientifically or medically proven to work or be safe so they could lead to substantial harm. This is yet another early step in a likely growing trend of states challenging FDA authority

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Silence from FDA Commissioner Robert Califf on stem cell clinics is a problem

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Robert Califf, FDA Commissioner

FDA Commissioners including Robert Califf have radically different approaches to the job including oversight of marketing of unproven stem cells. As to stem cell clinics, some have been very engaged, while others seem the opposite. During his second go as FDA Commissioner, Robert Califf has been vocal about many topics. However, as best as I

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