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December 01, 2020
Moderna has filed for authorization for its COVID-19 vaccine candidate, which has shown high efficacy and safety in a Phase III trial.
The expansion will include new suites for the development and clinical manufacturing of drug product intermediates and drug products and cGMP suites for early-phase cGMP manufacture.
The virtual assessments will address problems, issues, and questions customers have about their environments and operations.
Originally announced in March 2020, the acquired facility will be Bora’s first North American manufacturing facility and will serve as its North American headquarters.
The added space will house a portion of its PVC, polyurethane, silicone, and additional plastic tubing products, as well as its AdvantaPure products.
November 30, 2020
Behzad Mahdavi, PhD, will join a team of experts in the company’s Science and Technology Group to fast-track the adoption of new development and drug delivery technologies and manufacturing processes and techniques.
The expansion is part of a new expansion initiative aimed at increasing flexibility, efficiency, and cost-effective production.
The companies have entered into a global collaboration and license agreement to develop zuranolone (SAGE-217) for major depressive disorder, postpartum depression (PPD), and SAGE-324 for essential tremor and other neurological disorders.
November 24, 2020
FDA granted fast track designation for AB201, a small recombinant protein that is a potent, selective inhibitor of tissue factor, for the potential treatment of COVID-19.
The EC’s approval was based on positive results from a Phase III clinical trial that demonstrated a statistically significant and clinically meaningful improvement in patients compared to chemotherapy.