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Opinion: FDA commissioner: ‘Smarter,’ real-time clinical trials could transform drug development

Why does it take a new drug 10 years, on average, to come to market? Part of the reason lies in the dead time in the process.  

Historically, trials have required tedious tabulations and repeated application submissions between phases, which is why 45% of the time from a Phase 1 trial until final submission is spent without any ongoing clinical trial in progress — idle time in the system.   

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Why does it take a new drug 10 years, on average, to come to market? Part of the reason lies in the dead time in the process.  

Historically, trials have required tedious tabulations and repeated application submissions between phases, which is why 45% of the time from a Phase 1 trial until final submission is spent without any ongoing clinical trial in progress — idle time in the system.   

Read the rest…

Read More

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Vertex earnings get muted investor response

While overall revenue fell just shy of Wall Street forecasts, sales of the gene editing medicine Casgevy and pain drug Journavx missed analyst estimates by double-digit percentages.

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While overall revenue fell just shy of Wall Street forecasts, sales of the gene editing medicine Casgevy and pain drug Journavx missed analyst estimates by double-digit percentages.

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Vertex’s quiet Q1 is calm before potentially ‘iconic’ renal evolution

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While some analysts may regard Vertex Pharmaceuticals’ first quarter results as “unremarkable,” BMO Capital Markets wrote on Monday, the second half of 2026 could be big for the biotech, with the potential approval of IgAN therapy povetacicept.

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Foundayo’s liver failure blip weighs down Lilly shares. but analysts unconcerned

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The selloff in Eli Lilly’s shares was “overdone,” according to RBC Capital Markets, which noted that the overall safety profile of Foundayo remains favorable.

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