FDA's NDA And BLA Approvals: Xultophy, Soliqua
Original new drugs and biologics recently approved by US FDA.
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US FDA approves Xultophy and Soliqua, both fixed-ratio combinations of a basal insulin and a GLP-1 agonist, on the same day even though Sanofi redeemed a priority review voucher that earned Soliqua an earlier user fee goal date.
Bluebird bio’s Tom Klima told Scrip launch preparations are well under way, including negotiations with payers on outcomes-based reimbursement agreements.
AbbVie is to terminate the clinical development of lemzoparlimab for myelodysplastic syndrome and acute myelocytic leukemia and will also reduce the size of its 2020 deal with originator I-Mab by $445m, in the latest blow to the Chinese firm.