White Flag Raised: UniQure Gives Up On Glybera, But Not Gene Therapies
UniQure will not seek marketing authorization renewal for Glybera in the EU before it expires in October, but the company does not see the product's commercial failure as a sign that the market won't accept gene therapies or their high price tags.
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CSL/UniQure’s Hemgenix To Enter Uncertain EU Market After Regulatory Nod
The firms’ one-time hemophilia B gene therapy has been approved in the EU just months after a US nod, but concerns remain about its prospects on a market that has seen several setbacks for other gene therapies.
UniQure/CSL Set To Launch First Hemophilia B Gene Therapy Next Year At Record Price
The firms’ gene therapy Hemgenix has won a US thumbs up for the treatment of hemophilia B and plans are underway for a US launch with a big price tag that experts agree should pay off in the long-term.
US Vs. EU: Is Cell And Gene Therapy Reimbursement Easier Stateside?
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.