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September 09, 2020
AMRI will provide AstraZeneca with manufacturing capacity and sterile fill/finish services at its drug product manufacturing facility in Albuquerque, NM.
September 08, 2020
The clinical trials of the AstraZeneca Oxford COVID-19 vaccine, AZD1222, have been paused for a safety review as a result of an incident of an unexplained illness in a UK trial patient.
As public confidence in the drug development process waivers, leading vaccine developers promise to adhere to scientific and regulatory principles.
Industry leaders insist they will maintain high standards for clinical trials and regulatory submissions for new vaccines and therapeutics to combat COVID-19.
September 03, 2020
BIO leaders urge biopharmaceutical companies to apply scientific principles in seeking drug and vaccine approvals.
Rapid scale-up to billions of doses requires collaborative, all-out efforts by innovators, their manufacturing partners, and the entire supply chain.
Tight development timelines and accelerated approval pathways favor simple, cost-effective capsule formulations.
A device manufacturing process must be carefully designed in the early stages of development to ensure success in commercial manufacturing.
September 02, 2020
Amid high expectations for a vaccine, bio/pharma readies capacity, weighs pressures.
The companies have entered into a strategic partnership for the CMC development and manufacturing of Ansun’s biologics pipeline.