Bristol's Belatacept Could See Approval In Second Quarter After GMP Delay
This article was originally published in The Pink Sheet Daily
The kidney transplant drug Nulojix (belatacept) is finished at the plant in Puerto Rico that won't be inspection-ready until the end of the year following a August warning letter.
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FDA has agreed to review the anticoagulant based on the results of the AVERROES trial, offering a potentially faster route to market.
A number of recent FDA warning letters focused on GMP issues with aseptic processing, signaling the agency’s continuing concern about contamination prevention.
FDA's "complete response" letter for kidney transplant drug does not require that Bristol-Myers Squibb do additional clinical trials, but firm must provide updates from ongoing study before approval.