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There have been some recent successes on the accelerated assessment front in the EU but more requests are rejected than granted.
A bluebird executive spoke during ARM’s Cell and Gene Meeting On The Mesa about why the firm pulled Zynteglo out of the EU, but while progress has been made in the US, long-term challenges remain.
Takeda will use Poseida’s non-viral delivery and gene-editing capabilities for six liver- and hematopoietic stem cell-targeted gene therapies. The agreement follows recent gene therapy tie-ups with Selecta and Genevant.
It is not only gene therapy companies that have found European payers hard to convince of the value of their products. Amarin’s proposed European pricing may lead to another US company exit.
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