Immunology and Biotherapies
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Page Ressources et Actualités du DIU immunologie et biothérapies
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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 - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 May 2015

European Medicines Agency - News and Events - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 May 2015 | Immunology and Biotherapies | Scoop.it
From www.ema.europa.eu - May 25, 2015 12:29 PM
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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Krishan Maggon 's curator insight, May 22, 2015 8:53 AM

Two generic medicines received positive opinions from the CHMP: Bortezomib Accord(bortezomib) for the treatment of multiple myeloma and mantle cell lymphoma andPregabalin Zentiva (pregabalin) for the treatment of epilepsy and generalised anxiety disorder.
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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

From www.ema.europa.eu - December 21, 2014 11:48 AM
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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Krishan Maggon 's curator insight, December 20, 2014 11:46 AM
First stem-cell therapy recommended for approval in EU

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.
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