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Supporting ‘n of 1’ gene therapy development, the playbook from a Foundation for the National Institutes of Health-backed consortium aims to help investigators who are not traditional product sponsors prepare for meetings with US FDA and IND submissions.
Drug and device makers regularly use media to sway consumers. But some advocacy groups recently turned the tables by using social media to sway industry.
With many medtechs restructuring for core growth in the post-pandemic era, Abbott relied on organic growth in 2022 to move to the top of the global medtech ranking. The strength of the US dollar was not kind to companies reporting in local currencies on converting revenues to dollars.
In the top August alliance by deal value, Precision BioSciences licensed Imugene global rights to azercabtagene zapreleucel (azer-cel), its lead allogeneic anti-CD19 CAR T candidate for cancer. Imugene will assume ongoing clinical execution for azer-cel in the large B-cell lymphoma population who have relapsed following autologous CAR T treatment. The license also includes an option to develop up to three other cancer research programs in the future. Precision will receive $21m up front and is eligible for $8m upon successful completion of the Phase Ib dosing in the CAR T relapsed LBCL patient population. For azer-cel, Precision is eligible to receive up to $198m in additional milestone payments plus royalties. For each additional research program selected by Imugene, Precision is eligible for up to $145m in milestone payments and tiered royalties on net sales.
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