The FDA is preparing for a surge in cell and gene therapy submissions, with up to 10 regulatory decisions expected this year alone. The establishment of the Office of Therapeutic Products (OTP) is part of the FDA's response to the growing demand for regulatory review of these therapies. However, experts have warned that modernization of both the regulatory and access and reimbursement frameworks..
Gene editing companies Editas Medicine, Vertex Pharmaceuticals and CRISPR Therapeutics are all racing to develop treatments for sickle cell disease (SCD) and transfusion-dependent beta thalassemia. Editas recently unveiled early data from its RUBY and EdiTHAL trials, demonstrating the potential of its gene editor EDIT-301 in treating these diseases. However, Vertex and CRISPR also released posit..
The gene editing race between Editas Medicine and Vertex Pharmaceuticals with CRISPR Therapeutics has heated up as both companies released positive data for their sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT) hopeful treatments. Editas Medicine unveiled early data from the RUBY and EdiTHAL trials on Friday, demonstrating the potential of its gene editor EDIT-301 in t..
The gene editing race between Editas and Vertex, CRISPR heats up as both companies release positive data on their respective gene therapies for sickle cell disease and transfusion-dependent beta thalassemia. Editas unveiled early data from its RUBY and EdiTHAL trials, demonstrating the potential of its gene editor EDIT-301 in treating these diseases. However, Vertex Pharmaceuticals and CRISPR Th..
