Biopharmaceutical firm Gilead Sciences (Nasdaq: GILD) has announced the termination of its Phase 3 ENHANCE study in higher-risk myelodysplastic syndromes (MDS) due to a lack of promising results, according to a planned analysis. The safety data observed during the trial was found to align with the known profile of magrolimab, an investigational anti-CD47 immunotherapy drug […]
Gilead Sciences said that the US Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Veklury (remdesivir) usage in COVID-19 patients with severe renal impairment, encompassing those on dialysis. This approval positions Veklury as the sole antiviral COVID-19 treatment approved for use in all stages of renal disease. It’s estimated […]
Gilead Sciences has secured the approval of the US Food and Drug Administration (FDA) for Trodelvy (sacituzumab govitecan-hziy) for pre-treated HR+/HER2- metastatic breast cancer. The Trop-2 directed antibody-drug conjugate (ADC) is indicated for the treatment of adults having unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer […]
American biopharma major Gilead Sciences and immunotherapy company EVOQ Therapeutics have entered into a partnership to develop and market immunotherapy products. Under the collaboration and licensing agreement, Gilead Sciences will acquire the exclusive license for EVOQ Therapeutics’ NanoDisc technology to pursue product candidates for rheumatoid arthritis and lupus treatment. As per the agreement, EVOQ Therapeutics […]
Kite Pharma, a subsidiary of Gilead Sciences, and Daiichi Sankyo have received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for their Yescarta (axicabtagene ciloleucel) for initial treatment of relapsed/refractory large B-cell lymphoma (LBCL). Yescarta, a chimeric antigen receptor (CAR) T-cell therapy, is used only in patients who have not received a […]
Sunlenca FDA approval : Gilead Sciences has secured the approval of the US Food and Drug Administration (FDA) for Sunlenca (lenacapavir), in combination with other antiretroviral(s), for the treatment of human immunodeficiency virus type 1 (HIV-1). Sunlenca, a human immunodeficiency virus type 1 (HIV-1) capsid inhibitor, in combination with other antiretroviral(s), is indicated for the […]
Kite, an arm of Gilead Sciences, has agreed to acquire Tmunity Therapeutics, a Philadelphia-based clinical-stage biotech company focused on next-generation CAR T-therapies and technologies, for an undisclosed amount. Under the agreement, Kite will acquire all the shares of Tmunity Therapeutics, which it already doesn’t own. The acquisition aligns with Kite’s current in-house cell therapy research […]
Arcellx, a US-based clinical-stage biotechnology company, and Kite, a Gilead company, are partnering to co-develop and co-commercialize the former’s CART-ddBCMA, a late-stage product candidate. CART-ddBCMA, currently in phase 2 clinical development, is intended for the treatment of patients with relapsed or refractory multiple myeloma. Arcellx and Kite will share development, clinical trial, and commercialization costs […]
Gilead Sciences said that Trodelvy (sacituzumab govitecan-hziy) has been granted priority review from the US Food and Drug Administration (FDA) for the treatment of another type of metastatic breast cancer. The supplemental biologics license application (sBLA) filed by Gilead Sciences is for using the breast cancer drug in adults having unresectable locally advanced or metastatic […]
Gilead Sciences has agreed to acquire MiroBio, a clinical-stage British biotech company, in an all-cash deal worth around $405 million in a move to gain access to the latter’s pipeline of immune checkpoint agonists and drug discovery platform. The lead investigational antibody of MiroBio is MB272, which is a selective agonist of immune inhibitory receptor […]