Alembic Pharmaceuticals Limited has secured final approval for its abbreviated new drug application (ANDA) for Paclitaxel Injection USP, 30 mg/5 mL (6 mg/mL), 100 mg/16.7 mL (6 mg/mL), and 300 mg/50 mL (6 mg/mL) multiple-dose vials from the US Food & Drug Administration (FDA). According to the Indian pharma company, this is the maiden product […]
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 […]
Enhertu FDA approval : AstraZeneca and Daiichi Sankyo have secured approval for Enhertu (trastuzumab deruxtecan) from the US Food and Drug Administration for the treatment of a type of metastatic breast cancer in adult patients. Enhertu is said to be a specifically engineered HER2-directed antibody drug conjugate (ADC). It is being co-developed and commercialized by […]
BriaCell Therapeutics has secured the fast track status from the US Food and Drug Administration (FDA) for its lead candidate — Bria-IMT for the treatment of metastatic breast cancer. The US-based clinical-stage biotech company specializes in targeted immunotherapies for cancer. Bria-IMT is a cell-based immunotherapy, which has been designed to preferentially kill tumor cells without […]
Alphamab Oncology said that it has completed enrolling patients in China for its KN026-203 phase 2 clinical trial of the combination of KN026 and KN046 in the treatment of HER2-positive solid tumors. While KN026 is a HER2 bispecific antibody developed by the Chinese clinical-stage biopharma company, KN046 is a PD-L1/CTLA-4 bispecific antibody, developed by Jiangsu […]
BCAL Diagnostics is set to list on the Australian Securities Exchange (ASX) after an initial public offering that saw the Sydney-based breast cancer screening and diagnostic company raise AUD 10 million ($7.33 million) from investors. The IPO offer saw BCAL Diagnostics issue 40 million new shares at 25 cents per share, valuing the company at […]
ImmVira said that it has wrapped up the first dosing of its oncolytic virus product – MVR-T3011 intratumoral injection in phase 2 clinical trials both in China and the US. According to the Chinese pharma company, the US phase 2a portion of the study has two parts, of which the first is the evaluation of […]
Swiss healthcare company Roche has launched the Elecsys Anti-p53 immunoassay to help in the diagnosis of various types of cancer by the in vitro quantitative determination of anti-p53 antibodies. The Anti-p53 immunoassay test will help physicians in diagnosing oesophageal cancer, breast cancer, and bowel cancer in patients, in combination with other diagnostic tests, said Roche. […]
Olema Oncology has entered into a clinical trial agreement with Pfizer to evaluate its small molecule OP-1250 in combination with the latter’s palbociclib (IBRANCE) in advanced breast cancer. OP-1250 is an estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD). Its combination with the Pfizer breast cancer drug will be assessed in the […]
Merck acquisition of VelosBio : US pharma giant Merck has agreed to acquire VelosBio, a California-based clinical-stage biopharma company, for $2.75 billion in an all-cash deal, in a move to strengthen its oncology pipeline. VelosBio is engaged in developing cancer therapies that target receptor tyrosine kinase-like orphan receptor 1 (ROR1). The company’s lead investigational candidate […]