China’s NMPA accepts Legend Biotech’s NDA for cilta-cel
China’s National Medical Products Administration (NMPA) has accepted Legend Biotech’s New Drug Application (NDA) for ciltacabtagene autoleucel (cilta-cel).
China’s National Medical Products Administration (NMPA) has accepted Legend Biotech’s New Drug Application (NDA) for ciltacabtagene autoleucel (cilta-cel).
Genmab has filed a Japan new drug application (JNDA) with the Ministry of Health, Labor and Welfare (MHLW) of the country for subcutaneous epcoritamab (DuoBody-CD3xCD20) to treat relapsed/refractory (R/R) large B-cell lymphoma (LBCL) patients.
Gilead Company Kite has signed an agreement to acquire clinical-stage biotech company Tmunity Therapeutics, which is focused on next-generation CAR T-therapies and technologies, for an undisclosed sum.
Moleculin Biotech has received Fast Track designation from the US Food and Drug Administration (FDA) for WP1122 to treat Glioblastoma Multiforme (GBM), an aggressive malignant primary brain tumour.
Molecular science and technology company Caris Life Sciences (Caris) and data-driven precision biotherapeutics company Hummingbird Bioscience has announced a strategic collaboration to advance clinical development of latter’s anti-HER3 therapy, HMBD-001.
InnoCare Pharma has received approval from the Health Sciences Authority (HSA) of Singapore for HIBRUKA (orelabrutinib) to treat adult relapsed or refractory mantle cell lymphoma (R/R MCL) patients.
CG Oncology, an oncolytic immunotherapy company, has raised $120m through Series E financing round to advance its lead clinical programmes in bladder cancer towards FDA approval.
A clinical stage biotechnology company Immunomic Therapeutics has received Fast Track Designation (FTD) from the US Food and Drug Administration (FDA) for its ITI-3000 programme to treat patients with Merkel Cell Carcinoma (MCC).
Kite, a Gilead Company, has signed a global license agreement with Refuge Biotechnologies, a synthetic biology company for cancer immunotherapy, for exclusive rights to use latter’s gene expression platform to develop potential treatments for blood cancers.
Gilead Sciences company Kite has secured approval from the European Commission (EC) for Yescarta (axicabtagene ciloleucel) to treat adult patients with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL).