Sandoz submits Biologics License Application for proposed biosimilar trastuzumab to US FDA
Trastuzumab is monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2+) breast cancer and metastatic gastric cancers
Trastuzumab is monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2+) breast cancer and metastatic gastric cancers
In Japan, breast cancer is the most common cancer in women, with approximately 92,000 cases of breast cancer diagnosed in 2020
The NDA for Desidustat is based on positive data from the DREAM-ND and DREAM-D Phase 3 trials in patients with Chronic Kidney Disease (CKD) Not on Dialysis and Dialysis
The Summit will also witness participation of Union Minister of Health & Family Welfare and Chemicals & Fertilizers Dr. Mansukh Mandaviya
The product is synthetically developed as compared to the current process of drawing the same from blood plasma and is backed by a granted global patent
GlaxoSmithKline Pharmaceuticals Limited has reported consolidated financial results for the period ended September 30, 2021
Marketing authorisation holders are advised to submit any type IB variations or groupings of type IBs and type IAs by 3rd December 2021 for a start of procedure in 2021
The Phase 3 study is designed to bridge data collected from the vaccine efficacy trial conducted in India to the U.S. population
Pluss Advanced Technologies (PLUSS), has led the growth of energy storage materials across applications. Their proprietary Phase Change Material has gained wide acceptance in the pharmaceutical, logistics and food industries. The varied demands of the industry during Covid-19 has brought its technology into focus. Samit Jain, MD, PLUSS in conversation with Thomas C Thottathil discusses trends and outlines his plans for the business
Following the pre-NDA meeting with the U.S. FDA, the companies confirmed the current efficacy and safety databases are expected to be adequate for filing with confirmed pathways for MDD and PPD
Subscribe To Our Newsletter & Stay Updated