Keeping Track: Biosimilars, Novel Approvals, And Ebola
The latest drug development news and highlights from our US FDA Performance Tracker include a Neulasta biosimilar approval for Sandoz, novel approvals for Celgene's Reblozyl and Giskit B.V.'s ExEm Foam, and a submission for Regeneron's Ebola candidate.
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BMS Forgoes Thalassemia Label Expansion Revenues For Rebozyl
The firm was unable to respond to the US FDA’s questions on Reblozyl’s risk-benefit profile in an expanded beta-thalassemia setting and will now focus label expansion efforts elsewhere.
BMS's Reblozyl Data Supports Adding Less Severe Patients To Label
Adding non-transfusion-dependent anemia patients to the Reblozyl label is a key strategy for the product, which BMS expects to reach $4bn in annual sales.
Keeping Track: Oncology Submissions From Blueprint, Y-mAbs, BMS/bluebird; Approvals For BMS’ Reblozyl, LFB’s SevenFact
The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker.