Gilead Sciences, Inc.
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While the FDA considers a T cell malignancy risk to be applicable to all commercial CAR-T therapies, Gilead Sciences’ Tecartus has a revised warning that potential adverse events “may” occur.
Although the FDA did not outright say there is a causal secondary malignancy relationship, it asked BMS, Gilead, J&J and Novartis to add warnings to the labels of six CAR-T therapies noting the potential risks.
Amid a hot antibody-drug conjugate market in oncology, Gilead Sciences announced Monday that its ADC Trodelvy did not reach a primary endpoint in a non-small cell lung cancer trial.
Gilead’s stock traded lower on news that claims will proceed that allege the company delayed the development of newer, safer HIV drugs in order to maximize profits.
Israel-based cancer immunotherapy company Compugen will receive $60 million upfront from Gilead for the license to its antibody, which blocks the interaction between the IL-18 binding protein and IL-18.
A CAR-T cell therapy for autoimmune diseases generated significant attention at the 2023 American Society of Hematology (ASH) annual meeting and Arcellx and Seagen posted promising data.
The agency on Tuesday said it is investigating the “serious risk” of T cell malignancy outcomes, including hospitalization and death, and evaluating the need for potential regulatory action.
Months after the FDA lifted its partial hold on their Phase II multiple myeloma program, Kite and Arcellx are expanding their existing development and commercialization collaboration in the blood cancer space.
The third-quarter growth of Gilead’s HIV, oncology and cell therapy businesses was completely offset by declining COVID-19 and liver disease sales, with revenue flat compared to the same period last year.
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