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Advisory committee will discuss five types of toxicity risks with adeno-associated virus vector-based gene therapy products at a two-day meeting in September, which follows some recent high-profile instances of adverse events that have delayed development programs.
Adverum said it would cease developing ADVM-022 for DME and focus on wet AMD, but the adverse events that prompted the shift could invite further scrutiny in an already competitive market.
A patient developed Factor VIII inhibitors, but he had also recently received a COVID-19 vaccine and was genetically predisposed.
Intellia’s announcement of the first in vitro gene editing proof of principle sent shockwaves through the life science investment space. But are there still many known unknowns.
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