ASTELLAS PHARMA EUROPE LTD.

Katherine Talcott, MD, discusses potential therapies for geographic atrophy (GA) secondary to age-related macular degeneration (AMD) at OSN New York 2024, highlighting ANX007, Danicopan ALXN 2040, AVD-104, JNJ-1887, ASP7317, RG6501, elamipretide, Glideuretinal, AREDS/AREDS2, and ONL1204. ANX007 showed significant protection from vision loss in the ARCHER Trial, while Danicopan ALXN 2040 is an oral agent inhibiting complement factor D. AVD-104 demonstrated visual acuity gains in the SIGLEC study. Gene therapies like JNJ-1887 and ASP7317 aim to protect retinal cells. Elamipretide showed positive effects on visual function in the ReCLAIM study. Glideuretinal and AREDS/AREDS2 are antioxidants, and ONL1204 is a Fas inhibitor reducing retinal cell apoptosis.

Astellas praises EU & US regulators for collaboration in gene therapy, but emphasizes the need for better understanding of Asian markets.

Astellas withdraws Izervay's European approval filing, contrasting with its US success, and considers future actions for European market.

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AI and new technologies are crucial for early detection and personalized treatment of breast and gynecological cancers, aiming to improve accessibility and outcomes, especially in resource-limited settings.

Novartis pays $150M to Monte Rosa for molecular glue degraders targeting VAV1, potentially yielding $2.1B more. MRT-6160, in Phase 1, aims to treat autoimmune diseases. Novartis takes over Phase 2+ development, sharing Phase 3 costs and profits. Monte Rosa plans to extend its research with the funds.

Astellas withdraws EMA filing for avacincaptad pegol, a GA treatment, following EU regulator feedback. Despite US FDA approval as Izervay, no EU treatments exist for GA associated with AMD. Astellas remains committed to bringing the drug to market in Europe.

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Neural dust, microscopic wireless sensors, and artificial neurons enable continuous neuronal monitoring and stimulation, revolutionizing bioelectronic medicine with potential applications in treating neurological disorders, enhancing prosthetics, and creating brain-computer interfaces. Ethical considerations include safeguarding autonomy, ensuring informed consent, and preventing unauthorized access to neural implants.

FDA approves Vyloy, a zolbetuximab drug targeting CLDN18.2 protein in HER2-negative gastric/GEJ adenocarcinoma, used with chemotherapy. Clinical trials show improved survival and progression-free periods. Common side effects include nausea, vomiting, and diarrhea.