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New Drug Designations - July 2023

New Drug Designations – July 2023

Shots: PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, the EU, China, and Korea. This month’s report includes 7 biological drugs, 10 small molecules, 8 cell and gene therapies, 1 radiopharmaceutical, 2 microbiota and 1 diagnostic test MyoPax’ Satori-01, focused on repairing the Exstrophy-Epispadias Complex sphincter…

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Exclusive_Barbara Klencke_2022

Barbara Klencke, CMO at Sierra Oncology (now GSK) Shares Insights on the Significant benefits obtained from the Pivotal Myelofibrosis Study

Shots:Barbara gave a comprehensive view of the P-III (MOMENTUM) clinical study results which evaluates its lead candidate in myelofibrosisSierra is now acquired by GSK (completed on 1st July 2022) resulting in GSK commercializing this prime product once approvedThe interview outlines Sierra’s (now GSK) vision to develop transformative therapies for rare cancersSmriti: Thank…

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