Oncology

Innovent announces BTD in China for NSCLC with KRASG12C mutation therapy

Innovent Biologics has announced that China's National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) has granted breakthrough therapy designation (BTD) for IBI351 (GFH925).

Janssen submits MAA to European Medicines Agency for talquetamab

The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for talquetamab to treat patients suffering with relapsed or refractory multiple myeloma (RRMM).

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).

Genmab files NDA for large B-cell lymphoma treatment in Japan

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.

Kite signs agreement to acquire biotech company Tmunity Therapeutics

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 receives Fast Track designation for Glioblastoma Multiforme therapy

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.

Caris and Hummingbird Bioscience collaborate to advance anti-HER3 therapy

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 receives approval in Singapore for mantle cell lymphoma therapy

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 raises $120m through Series E round

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.