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Cell Therapy Plots European Conditional Approval For Heart Regeneration Product

 
• By Sukaina Virji

Cell Therapy Ltd says that following a pre-submission meeting with the European Medicines Agency (EMA) in September, it now plans to begin applying for a conditional marketing authorization (CMA) for Heartcel, its lead allogeneic stem cell therapy, which has been designed to regenerate the heart. Filing is planned for mid-2016, and, if successful, approval could be granted as early as 2017.

Cell Therapy Ltd says that following a pre-submission meeting with the European Medicines Agency (EMA) in September, it now plans to begin applying for a conditional marketing authorization (CMA) for Heartcel, its lead allogeneic stem cell therapy, which has been designed to regenerate the heart. Filing is planned for mid-2016, and, if successful, approval could be granted as early as 2017.

Cell Therapy's CEO Ajan Reginald (previously Roche's global head of emerging technologies) spoke to Scrip earlier this year in detail about Heartcel and his company's plans for commercialization in...

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