Companies involved in human gene editing have entered the ethical debate about the controversial technology, issuing a joint declaration that DNA must not be altered in a way that passes genetic changes on to future generations. The Alliance for Regenerative Medicine (ARM), an international group representing the cell and gene ...
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The Committee for Medicinal Products for Human Use (CHMP), the European Medicines Agency’s (EMA) committee responsible for human medicines, has recently adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product ”Deferasirox Mylan”, intended for the treatment of chronic iron overload due to blood transfusions in patients with ...
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Zynteglo, Bluebird Bio’s ex vivo gene therapy for β-thalassaemia, got a green light from the EMA for conditional marketing authorization making it the 1st gene therapy for patients with thalassaemia to win such an approval. The one-time gene therapy has been approved for patients 12 years and older with ...
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The European Medicines Agency (EMA) has published a booklet describing the journey of a medicine for human use authorised through EMA, from initial research to discussions on patient access to medicines across the EU. The booklet’s title is ”From laboratory to patient: the journey of a centrally authorised medicine” ...
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