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The Niche
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Stem Cell & Regenerative Med Newsletter
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Weekly reads: teratoma in iPSC trial, Piero Anversa & friends, Athersys, China Initiative
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It's been mostly a downbeat week on the stem cell news front including a deep revisit by Reuters to the Piero Anversa case that has new revelations. It's ugly stuff involving other folks too. We'll start on the iPS cell front, where a trial participant had a teratoma. I've had a long-standing interest in the relationship between stem cells and …
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What is an FDA warning letter & how should firms respond
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Firms that are active in the biologics space face many possible challenges but the possibility of getting an FDA warning letter is one of the most intense. The goal of today's post is to explain what an FDA warning letter is all about. This analysis includes what such a letter means and what steps come next. How does this play …
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