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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AbbVie partners with Iambic on AI-driven drug discovery as Telix Pharmaceuticals moves to acquire ITM Isotope Technologies in a multibillion-dollar radiopharmaceutical merger, Novo Nordisk's CagriSema outperforms Eli Lilly's tirzepatide in a head-to-head diabetes trial, and Jen Lamppa of Inovalon discusses how real-time clinical data is reshaping trial recruitment.
AbbVie partners with Iambic to deploy its AI molecular superintelligence platform, while Telix Pharmaceuticals agrees to acquire radioisotope leader ITM.
Novo Nordisk reports that CagriSema delivered 12.4% average weight loss in a late-stage diabetes trial, outperforming tirzepatide's 9.1% at comparable doses.
Inovalon's Jen Lamppa on how real-time clinical data feeds validate patient eligibility at enrollment — reducing burden while improving accuracy.
FDA approves Ultragenyx's Fayuvi as the first treatment for Sanfilippo syndrome type A, Lisata Therapeutics acquires Marea Therapeutics as mAbxience partners with Sandoz on a hemophilia A biosimilar, and Joe Cunningham argues that executive drug-pricing deals alone won't fix costs.
Lisata Therapeutics acquires Marea Therapeutics and secures $225 million in concurrent financing, while mAbxience and Sandoz partner to develop and globally commercialize an emicizumab biosimilar.
FDA approved Ultragenyx's Fayuvi (rebisufligene etisparvovec-hopf) as the first treatment for MPS IIIA Sanfilippo syndrome type A.
Former Rep. Joe Cunningham (D-SC), now spokesperson for the Pharmaceutical Reform Alliance, argues that codifying Most-Favored-Nation pricing into law is the real fix for drug costs.
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