Biotech | January 22, 2022
Pfizer and OPKO update on the Biologics License Application for Somatrogon
Pfizer is evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward
Pfizer is evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward
Trastuzumab is monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2+) breast cancer and metastatic gastric cancers
Immatics to receive upfront payment of US $ 150 million and additional milestone payments of up to US $ 770 million plus tiered double-digit royalties on net product sales
The multi-target agreement covers five programmes focused on off-the-shelf vaccines for cancer and infectious disease
U.S. FDA has accepted the investigational new drug application for phase 1 clinical trial in non-Hodgkin’s lymphoma
It falls under the Department of Biotechnology - Mission Covid Suraksha Project for augmenting manufacturing capacity for Covaxin
Winlevi has been approved by the United States FDA as a novel drug with a unique mechanism of action for the topical treatment of acne in patients 12 years and older
The said batches have successfully passed all the checks for quality parameters both at the Gamaleya Center in Russia and at the Central Drug Laboratory, Kasauli in India
2DG has been given emergency approval by the Drug Controller General of India (DCGI) for use on COVID-19 patients in the country
NATCO Pharmaceuticals, Hyderabad; Alembic Pharmaceuticals, Vadodara; Gufic Biosciences Ltd., Gujarat; Emcure Pharmaceuticals, Pune; and Lyka, Gujarat are new manufacturers
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