Zenocutuzumab

FDA to decide on Journey's rosacea drug DFD-29, Merus' bispecific antibody for NSCLC and PDAC, PTC's gene therapy Upstaza for AADC deficiency, and Autolus' CAR T therapy obe-cel for ALL by November 4, 6, 13, and 16 respectively.

October saw FDA approvals for Pfizer's Hympavzi, Astellas' Vyloy, and Iterum's Orlynvah. November awaits decisions on Journey Medical's DFD-29, Merus' Zenocutuzumab, Astellas' IZERVAY, PTC Therapeutics' Upstaza, Autolus' Obe-cel, Applied Therapeutics' Govorestat, BridgeBio's Acoramidis, and Jazz Pharmaceuticals' Zanidatamab.

Oncology dominates pharmaceutical innovation, with 1,600 cancer drugs in development. Spending on cancer drugs is projected to reach $409 billion by 2028, with high costs for novel agents. Biosimilars and generics may provide savings but cannot match rising expenditures. The focus is shifting towards cell therapies for solid tumors, with 44% of trials initiated in 2023 targeting solid tumor indications. Several cancer drugs have been approved by the FDA this year, and many more are expected to receive approval decisions soon.

Bio-pharma advances in endocrinology, dermatology, cardiovascular, oncology, rare diseases, pulmonology, gastroenterology, and neurology highlight promising therapies like Eli Lilly’s orforglipron, Amgen’s MariTide, Novo Nordisk’s oral semaglutide, Johnson & Johnson’s JNJ-2113, Sanofi’s amlitelimab, Ionis’s olezarsen, BridgeBio’s acoramidis, NewAmsterdam Pharma’s obicetrapib, Jazz Pharmaceuticals’ zanidatamab, Syndax’s revumenib, Merus’ zenocutuzumab, Johnson & Johnson’s nipocalimab, Novo Nordisk’s Mim8, Solid Biosciences’ SGT-003, Merck’s sotatercept, Johnson & Johnson’s Tremfya, and Crossject’s Zepizure, with analyses including clinical data, revenue forecasts, and expected launch dates.