Keeping Track, Oncology Edition: Biologic Breakthroughs And BLAs
The latest oncology development news and highlights from our US FDA Performance Tracker.
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Public Company Edition: The last biopharma initial public offering in the US was on 11 November, but follow-on and other offerings are generating hundreds of millions of dollars. Among RNA drug developers, Ionis issued more than $500m in new debt, while Arrowhead raised $266.8m.
Phase Ib data at ASH look competitive with new pivotal trial results for Bristol/bluebird’s leading BCMA CAR-T bb2121. The Phase II portion of the CARTITUDE-1 study for JNJ-4528 is fully enrolled.
AstraZeneca and Merck seek to add a pancreatic cancer indication for olaparib, while Merck has hopes of broadening pembrolizumab’s use in bladder cancer; two-day Oncologic Drugs Advisory Committee meeting also will include reviews of Celgene’s luspatercept in myelodysplastic syndromes-related anemia and Epizyme’s tazemetostat for epithelioid sarcoma.