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Twelve new drugs are now being reviewed for potential EU marketing approval, including Servier’s vorasidenib for IDH-mutant diffuse glioma, which the company says could become the first targeted therapy for the malignant and incurable brain tumor.
Pipeline is concentrated around Phase II, but sponsors have a few chances to see how FDA handles its ‘foundational constructs’ for psychedelic drugs, led by Lykos’ pending NDA for PTSD and Compass Pathways’ Phase III synthetic psilocybin COMP360 for treatment-resistant depression.
Flexible thinking and rigorous standards will both be needed to develop psychedelics as drug therapies in order to surmount the many complicating factors, from unique ‘set and setting’ aspects to functional unblinding, speakers at Reagan-Udall Foundation meeting agree.
10 orphan drugs imported from overseas, and 40 new drug approvals, including many from domestic developers, capped 2023 as one of the busiest years for China's drug regulatory agency, as Beijing pivoted to emphasizing affordable innovation and expanding access to newer therapies for rare conditions.
- Gene Therapy, Cell Therapy
- Large Molecule
- Other Names / Subsidiaries
- Aastrom Biosciences, Inc.
- Genzyme Biosurgery
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