ASTELLAS PHARMA

The global antibody drug conjugate market is projected to grow from USD 7.72 billion to USD 23.3 billion by 2035, driven by advancements in antibody engineering and clinical trial successes. Over 280 ADCs are approved or in clinical studies, with 250+ in early development. Key segments include breast cancer, solid tumors, and HER-2 antigen. North America leads in market share, while Asia-Pacific shows higher growth potential.

AffyImmune Therapeutics appoints Deyaa Adib, M.D., as Chief Medical Officer, bringing 28 years of oncology experience. Adib will oversee clinical activities, including strategic direction and execution of development programs. He has led successful registrations in solid tumor and hematologic malignancy indications and has held CMO roles at FibroGen, Triumvira Immunologics, Rain Therapeutics, and Blueprint Medicines.

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Astellas Pharma received a Complete Response Letter from the FDA for avacincaptad pegol, while Aldeyra Therapeutics' topical reproxalap for dry eye disease had its NDA accepted. Dr. Valerie Biousse discussed the benefits of non-mydriatic fundus cameras in emergency departments, enabling remote diagnosis and reducing ED length of stay. Dr. Jonathan Brugger highlighted the correlation between energy drink consumption and retinal vein occlusions in young adults.

FDA issued a Complete Response Letter for Astellas Pharma's sNDA of avacincaptad pegol for geographic atrophy secondary to AMD, citing a statistical labeling issue. Astellas remains committed to addressing FDA feedback and advancing GA treatments.

Claudin18.2 targeted therapy market sees Vyloy (zolbetuximab) approval in 2024, with over 60 drugs in clinical trials, focusing on gastric cancer and expanding to other tumors. China emerges as a key innovator, with Innovent, MabWorks, and Biotheus leading progress.

Claudin18.2-targeting therapy market growth driven by encouraging results and expanding pipeline, with G/GEJ malignancies primary focus. Global market includes Western and Asian enterprises fostering innovation. Vyloy (zolbetuximab) first approved therapy, with strong sales and global expansion. Numerous other therapies in development, highlighting Claudin18.2's therapeutic potential. Companion diagnostics crucial for treatment precision.

The E-Learning module covers non-clear cell renal cancers' classification, incidence, prognosis, molecular alterations, and current management, emphasizing the need for subtype-specific clinical trials and biomarkers. It details treatments like mTOR and tyrosine kinase inhibitors, MET inhibitors, immune checkpoint inhibitors, and their combinations, highlighting the best response rates with these combinations and the logical approach of MET inhibition in MET-driven tumors.

Astellas' request to update Izervay's prescribing info rejected by FDA; Jupiter Bioventures, co-founded by Norman Sharpless and Nathaniel David, launches with $70M to create biotech startups; Bayer pays Cytokinetics $53M for aficamten licensing in Japan; Neurogene continues Rett syndrome gene therapy trial at lowest dose after side effects; Cybin's stock dips despite positive Phase 2 data for CYB003; Novartis licenses radiopharmaceutical from Ratio Therapeutics, targeting SSTR2 protein.

The FDA issued a Complete Response Letter to Astellas Pharma Inc. for IZERVAY, citing a statistical issue in proposed labelling language, not safety or efficacy. Astellas plans to work with the FDA to address the feedback.