The biotech argues that success in reducing fibrosis is more important than the failed primary endpoint measuring NAFLD activity score improvement – and also meets FDA's expectations – but the firm is taking a beating nonetheless.
Tobira Therapeutics Inc.'s CENTAUR trial may have failed on the primary endpoint, but the firm argues that the success on a key secondary endpoint of its Phase IIb study of cenicriviroc in NASH fits FDA's expressed standards for approval.
On July 25, Tobira announced that cenicriviroc (CVC), its dual CCR2/CCR5 inhibitor, missed the primary endpoint of improvement in the...
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A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
To make your document look professionally produced, Word provides header, footer, cover page, and text box designs that complement each other. For example, you can add a matching cover page, header, and sidebar. Click Insert and then choose the elements you want from the different galleries.
