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April 06, 2021
The company has introduced Opto Assure, a series of assays that provide yield and product quality data at an earlier stage in cell-line development.
Under the terms of the expanded agreement, Catalent will provide Moderna with a new high-speed vial filling line until June 2023 along with inspection, labeling, cartoning, and final packaging for potential pipeline programs.
April 05, 2021
The first revision further clarifies the number of doses per vial for the vials that are already available, while the second revision allows for the availability of an additional multi-dose vial.
Following a manufacturing mix-up, J&J will extend its oversight at Emergent’s Maryland facility; AstraZeneca manufacturing to relocate.
April 02, 2021
Concerns over vulnerability in the supply chain has increased pressure on FDA to renew site visits of domestic and foreign facilities.
The White House’s American Jobs Plan includes investment in new technologies for rapid scale up of vaccine production, in expanded emergency production capacity and enhanced US infrastructure for biopreparedness, and in greater production onshore of APIs.
April 01, 2021
Human error at an Emergent BioSolutions facility cited as cause for the loss of a large batch of COVID-19 vaccines.
The business, which has been renamed Woodstock Sterile Solutions, will operate out of a single site in Woodstock, IL, and will support clinical- to commercial-stage formulation and manufacturing.
A Phase III trial evaluating the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, in adolescents 12 to 15 years of age showed 100% efficacy and positive antibody responses.
March 31, 2021
The acquisition will give Amgen access to Rodeo's 15-prostaglandin dehydrogenase program, which will strengthen its inflammation portfolio.