Safety Thumbs Up For Zynteglo Prompts Bluebird To Lift Marketing Suspension
US Filing For The β-Thalassemia Gene Therapy Is On Track
No evidence has been found linking the viral vector in bluebird’s gene therapy for β-thalassemia to blood cancer, the European Medicines Agency says.
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Lawyer and industry expert Alexander Natz sets out some important dos and don’ts for securing a successful launch of an advanced therapy in Germany.
The European Medicines Agency is reviewing the safety of bluebird bio’s beta thalassaemia gene therapy, which is so far only approved in the EU and has only been used in one patient outside the context of clinical studies.
The UK Thalassaemia Society says that HTA body NICE fails to properly incorporate patient experiences into its decision making and that its patient engagement processes need reform. The marketing of Zynteglo, the gene therapy from bluebird bio for which the group is advocating, has just been temporarily suspended.