Zynteglo Authorization Renewal Paused While EU Regulators Examine Safety Concerns
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.
You may also be interested in...
The jury is still out on the case of MDS and some remaining questions regarding the AML case may still hinder commercial uptake.
The sponsors of seven new drugs are set to find out this week whether the European Medicines Agency’s human medicines committee, the CHMP, will recommend pan-EU approval for their products. CHMP action is also expected regarding two potential combination therapies for COVID-19.
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.