Advanced Therapy Developers Urged To Monitor Major EU Proposal On Using Blood, Tissues & Cells
Companies have the opportunity to tell the European Commission what they think about its proposed regulation that would overhaul the rules governing the use of substances of human origin.
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Leniolisib has become the first product to be granted accelerated assessment status by the European Medicines Agency this year.
France is set to become the first country in Europe to fund Imcivree for a second – and as yet unapproved – indication. Meanwhile, England has agreed to reimburse the drug for its approved indication as did Germany earlier this year. Reimbursement discussions are underway in the rest of Europe.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add two new products, including Upstaza, PTC Therapeutics’ disease-modifying gene therapy for children with the fatal, rare genetic disorder, AADC deficiency.