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European Union agency responsible for the protection of public and animal health through the scientific evaluation and supervision of medicines.
Via Krishan Maggon
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Rescooped by Gilbert C FAURE from Pharma Biotech Industry Review (Krishan Maggon) |
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European Medicines Agency - News and Events - First stem-cell therapy recommended for approval in EU
Via Krishan Maggon
New treatment for rare condition caused by burns to the eye
The applicant for Holoclar is Chiesi Farmaceutici S.p.A.The active substance of Holoclar is ex-vivo expanded autologous human corneal epithelial cells containing stem cells.Holoclar was designated as an orphan medicine and an advanced therapy medicinal product (ATMP) and EMA provided protocol assistance to the applicant during the development of the medicine on multiple occasions. Both orphan and ATMP designations and the associated incentives, such as free scientific advice or protocol assistance, are among the Agency’s most important instruments to encourage the development of medicines for patients suffering from rare diseases, and the development of innovative medicinal products.