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Adopting technological advances in upstream and downstream processes is vital to the gene therapy space, says Kai Lipinski, CSO at ReciBioPharm. Here he explores emerging technology trends and discusses how they can help to overcome key challenges facing gene therapy manufacturers.
The first gene therapy for haemophilia B has been given conditional marketing authorisation in Europe by the European Commission.
Medicines which represented significant progress in their therapeutic areas have been listed in the European Medicines Agency's Human Medicines Highlights 2022 report.
A total of five drugs were recommended for approval at the CHMP’s December meeting, including a gene therapy and two cancer drugs.
Gene therapy etranacogene dezaparvovec has been granted a positive opinion by the CHMP as a haemophilia B treatment for adults in Europe.
Hemgenix, the first gene therapy for adults with Haemophilia B has been approved by the US Food and Drug Administration (FDA).
