Feature|Videos|January 2, 2025
Approaching Institutional Biosafety Committee Approval for CAR T-cell Therapy
Proper planning can assist in the institutional biosafety committee (IBC) review process when preparing for CAR T-cell clinical trials.
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IBC approval has become a larger hurdle when conducting clinical research. This review process often adds two to three months to the timeline that must be accounted for in order for CAR T-cell sites to be IBC certified. It requires training from both the sponsor and CRO perspective. Our panelists highlight how to work through this process and what extra thought is needed behind planning for clinical trials.
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Median Drug Launch Prices Hit $257,000 as Access Barriers Persist, ICER and West Health Report Finds
Median net launch prices for new drugs climbed between 2022 and 2025 to $257,000, according to a new ICER and West Health report that also found persistent coverage and access barriers for patients.
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Roundup: Gilead Acquires Oral IL-23R Inhibitor From PepStar for $1.275 Billion, Zymeworks Licenses DLL3-Targeting T Cell Engager to Roche
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FDA Approves Hibsago (Bepirovirsen) for Chronic Hepatitis B
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FDA Grants Ultomiris Accelerated Approval in the U.S. for Adults with Primary Immunoglobulin A Nephropathy
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Pharmaceutical Executive Daily: FDA Grants Ultomiris Accelerated Approval in the U.S.
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