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FDA Accelerates Review Of Sickle Cell Disease Medicine Crizanlizumab

Novartis announced earlier today the FDA accepted the company’s Biologics License Application (BLA) and has granted Priority Review for its investigational Sickle Cell (SCD) medicine Crizanlizumab. If FDA-approved, crizanlizumab is expected to represent the first monoclonal antibody targeting the P-selectin mediated multi-cellular adhesion in sickle cell disease! Novartis submitted the application ...

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Drones Land in the Cell and Gene Therapy Space

Cell and gene therapies could be literally flying high soon from now! The Italy-based biotech company Anemocyte, in collaboration with RPS Aerospace,  developed a remotely piloted drone system to securely transport final cell and gene therapy products straight from manufacturing sites to clinical centers. The current prototype can also transport ...

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Bluebird puts €1.58m price on gene therapy Zynteglo

  Bluebird bio Inc. set a price for its gene therapy, Zynteglo, at 1.58 million euros ($1.78 million) over five years, after winning conditional approval in Europe earlier this month to to treat patients 12 years and older with transfusion-dependent β-thalassaemia (TDT), who have no matching donor for a stem ...

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TIF’s e-registry for patients with thalassaemia is ready for piloting

  TIF with support from Celgene Corporation, has developed a disease specific e-registry with health record for patients with thalassaemia. This e-registry is now completed, as a first version, and is ready to be piloted in selected centres in Cyprus, Greece and Bulgaria. After piloting and user comments, the e-registry ...

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Gene Therapy and Thalassaemia: The Patients‘ Perspective survey!

  A significant number of gene therapy approaches are currently undergoing clinical trials, some of which are already producing encouraging results. The Bluebird Bio’s gene therapy product, under the name ZYNTEGLO™, has received positive comments from the scientific committees of the European drug regulatory authority (EMA). This means that the practical ...

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Living with Transfusion-Dependent β-Thalassaemia (TDT)

In its most severe form and without adequate care, thalassaemia can be lethal in early childhood, and although  International Thalassaemia Day has come and gone, awareness is paramount.   Andrew Obenshain, Head of Europe at gene therapy company bluebird bio, looks into what it means to live with thalassaemia, with ...

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