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4660 News Found

Sandoz submits Biologics License Application for proposed biosimilar trastuzumab to US FDA
Biotech | December 21, 2021

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 Deruxtecan supplemental New Drug Application for breast cancer submitted in Japan
Biotech | December 14, 2021

Trastuzumab Deruxtecan supplemental New Drug Application for breast cancer submitted in Japan

In Japan, breast cancer is the most common cancer in women, with approximately 92,000 cases of breast cancer diagnosed in 2020


Zydus Cadila submits NDA to Drug Controller General of India for Chronic Kidney Disease
Biotech | November 23, 2021

Zydus Cadila submits NDA to Drug Controller General of India for Chronic Kidney Disease

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


PM to inaugurate first Global Innovation Summit of Pharmaceuticals sector
News | November 17, 2021

PM to inaugurate first Global Innovation Summit of Pharmaceuticals sector

The Summit will also witness participation of Union Minister of Health & Family Welfare and Chemicals & Fertilizers Dr. Mansukh Mandaviya


Shilpa Biologics permitted to conduct Phase 1 study on NavAlbumin
Biotech | November 05, 2021

Shilpa Biologics permitted to conduct Phase 1 study on NavAlbumin

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 posts Q2FY22 consolidated PAT at  Rs. 204.24 Cr
News | November 01, 2021

GlaxoSmithKline posts Q2FY22 consolidated PAT at Rs. 204.24 Cr

GlaxoSmithKline Pharmaceuticals Limited has reported consolidated financial results for the period ended September 30, 2021


EMA encourages companies to submit type I variations by end- November
Policy | November 01, 2021

EMA encourages companies to submit type I variations by end- November

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


Ocugen submits IND application with U.S. FDA for Covaxin phase 3 trial
Biotech | October 28, 2021

Ocugen submits IND application with U.S. FDA for Covaxin phase 3 trial

The Phase 3 study is designed to bridge data collected from the vaccine efficacy trial conducted in India to the U.S. population


We are marketing all our products globally: Samit Jain, MD, PLUSS
interviews | October 25, 2021

We are marketing all our products globally: Samit Jain, MD, PLUSS

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


Sage Therapeutics and Biogen plan to submit a New Drug Application (NDA) for zuranolone
Biotech | October 21, 2021

Sage Therapeutics and Biogen plan to submit a New Drug Application (NDA) for zuranolone

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