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Use of expedited pathway based on drug’s effect on brain amyloid would be problematic given advisory committee’s views of a disconnect between biomarker data and clinical efficacy results; however, one FDA expert sees potential for agency to grant accelerated approval on basis of an intermediate clinical endpoint – the same endpoint on which Biogen seeks regular approval.
The pandemic may accelerate a move toward versatile, single-solution renal replacement therapy in intensive care.
With two landmark advisory committee meetings coming up, the Pink Sheet reflects on some of the most memorable panel meetings over the last 20 years.
Pandemic-related collaborations between Hoth/VCU; Sorrento/Mt. Sinai Health; Audax/Northeastern U.; Alkido/U. of Maryland, Baltimore; Active Motif/Hisun BioRay/Fudan U. and more.