The Austedo approval is notable for two reasons: One, it is the first deuterated drug (i.e., a drug containing the stable isotope — deuterium — in place of a hydrogen atom) to be approved by ...
It is the first deuterated drug to be reviewed by the FDA, Teva noted. No further clinical trials were needed, so Teva has been able to re-file quickly, and the FDA has set a decision date of ...
I remind readers that a deuterated drug is a molecule in which a hydrogen atom has been replaced by a deuterium atom; deuteration is a common approach in drug discovery. Cybin states that CYB003 ...
Vertex acquired the deuterated drug from Concert Pharmaceuticals in 2017 for $160 million up front and up to $90 million in milestones. The FDA approved the new combination therapy on the basis of ...
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FDA Grants Cybin Breakthrough Therapy Status For Major Depression Psilocybin Therapy, Company Announces Positive Clinical Data & Canadian $150M Private Placementannounced that the Food and Drug Administration has granted Breakthrough Therapy designation to CYB003, its proprietary deuterated psilocybin analog targeting the adjunctive treatment of Major ...
“Looking ahead, we are excited about Cybin’s next phase of investigation and growth and for the upcoming milestones, including a readout of topline efficacy data from our CYB004 Phase 2 GAD study in ...
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