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July 01, 2020
Phesgo is a fixed-dose-combination subcutaneous injection of Perjeta (pertuzumab) and Herceptin (trastuzumab) for treating HER2-positive breast cancer.
The complete response letter was issued for a biologics license application for Abicipar pegol, an investigational treatment for wet age-related macular degeneration, based on FDA’s determination of an unfavorable benefit–risk ratio.
Appropriate analytical assays are needed to determine and ensure that biosimilar critical quality parameters are on track.
June 30, 2020
Aji Bio-Pharma launched Ajility, a flexible platform for manufacturing vaccines and therapies.
The guidance document provides recommendations regarding data needed for the manufacturing, development, and approval of a COVID-19 vaccine.
June 29, 2020
The refurbishment provides enhanced glass melting power, improved glass distribution, and the production of transparent and amber type I glass bottles to meet the increase in demand for glass vials for vaccines and life-saving medicines.
June 26, 2020
The company’s oral COVID-19 vaccine has been chosen to participate in a non-human primate challenge study organized and funded by Operation Warp Speed.
June 25, 2020
The test results could potentially be used in the development of COVID-19 vaccines and the screening of convalescent plasma for prophylactic and therapeutic use.
Catalent will offer vial filling, packaging capacity, and additional staffing at the site to support the production of the initial 100 million doses of the vaccine candidate to supply the US market beginning in the third quarter of 2020.
The company has expanded its laboratory test portfolio with five new molecular, serology, and functional assays for COVID-19 vaccine and therapy development programs.
