US FDA officials have supported tumor mutation burden as a biomarker, but analysts question whether a subset analysis of CheckMate 227 will be enough to support approval of Bristol's Opdivo/Yervoy combination in first-line lung cancer.
Bristol-Myers Squibb Co.'s surprise announcement that its Phase III CheckMate 227 first-line lung cancer study succeeded, but in a subset analysis that had not been prospectively defined, left one burning question – does the company have enough to file for approval? Management suggests the answer is yes, but some leading analysts have doubts.
The CheckMate 227 study is a multi-arm trial evaluating Bristol's PD-1 inhibitor Opdivo (nivolumab) with its CTLA-4 inhibitor Yervoy (ipilimumab)...
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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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
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