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Iovance Biotherapeutics’s Amtagvi is now the first FDA-approved treatment based on type of cell called a tumor-infiltrating lymphocyte. The regulatory nod in advanced melanoma also makes Amtagvi the first cell therapy approved for treating a solid tumor.
From diagnostics to treatment methodologies, BCI technology can unravel new dimensions of understanding and intervention, fundamentally altering the landscape of patient care.
There is growing and coordinated momentum behind the goal of ensuring connected medical devices improve people’s lives without introducing them to cybersecurity threats and associated safety risks. There also is a proven playbook for implementing the type of multi-layered, security-by-design strategies these initiatives advocate.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Sanofi, which is leading development of the Denali Therapeutics-partnered molecule, disclosed little about the clinical trial results in ALS. But this Phase 2 failure follows the 2020 clinical trial pause of a different partnered molecule that addresses the same target.