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CAR-T therapy-associated T-cell malignancies that the US FDA is investigating could make the treatments less attractive in autoimmune diseases than in oncology, but patients in both settings already accept some cancer risk with other available medicines.
Akero hopes to begin Phase III study of efruxifermin this year, with 89bio working to enter Phase III with pegozafermin in 2024. But just behind them, Boston Pharmaceuticals thinks it has a convenience and immunogenicity edge.
Hopes are that the impact of the US FDA’s investigation into a small number of T-cell malignancies associated with CAR-T therapies will be small since the benefit/risk profile still looks sound.
Formycon has submitted its aflibercept candidate for European Medicines Agency consideration, following an incredibly strong Q3 which has put the company on track for a promising future.
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