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Bristol's Kidney Transplant Drug Belatacept Finally Approved

This article was originally published in The Pink Sheet Daily

Executive Summary

Large patient registry will help keep tabs on risk for post-transplant lymphoproliferative disorder.

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Bristol's Focused BioPharma Strategy Starts To Pay Off

While many of the world's leading drug companies have relied on mega-mergers and diversified portfolios to drive growth over the last five years, Bristol-Myers Squibb Co. has taken a different tact, jettisoning non-core businesses, slashing overhead and jobs, and announcing a plan to focus its portfolio solely on biopharma.

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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.

Bristol Sacrifices Part Of Indication For Kidney Transplant Drug Belatacept

Bristol-Myers Squibb is willing to tailor the patient population for its kidney transplant agent belatacept by selecting for a biomarker and limit use by recommending the less intensive treatment regimen to try and avoid the risk of post-transplant lymphoproliferative disorder that was seen in clinical trials

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