WHO's Human Genome Editing Standards Must Not Impact Somatic Cell Research
Concerns have been expressed that efforts by the World Health Organization to establish global standards for the whole spectrum of human genome editing research may inadvertently have a negative impact on companies developing somatic cell therapy medicinal products.
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A new global registry is being set up to log all research involving genome editing, and there are plans for an online consultation on a governance framework on such research. The Alliance for Regenerative Medicine has welcomed the fact that the new registry will not be as burdensome for therapeutic developers as it originally thought.
New treatments for advanced endometrial cancer and hereditary angioedema are among six drugs that have just been recommended for EU-wide approval. Harmonized EU advice has also been issued in relation to an investigational antibody combination for treating COVID-19.
As part of its big data initiative, the European Medicines Agency is supporting projects that will help identify appropriate real-world data sources for regulatory decision making.