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Latest From Chelsea Therapeutics International, Ltd.
Biogen’s Aducanumab: Why Accelerated Approval Might, And Might Not, Be An Option For US FDA
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.
COVID-19 Lessons: Experts Predict Shift Toward Intermittent Hemodialysis In ICUs
The pandemic may accelerate a move toward versatile, single-solution renal replacement therapy in intensive care.
The Greatest US FDA Advisory Committees: A Look Back At Tumult And Turning Points
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.
Tech Transfer Roundup: Hoth Teams With VCU On Therapy To Block COVID-19 Replication
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.