Proving a survival benefit in the head-to-head ENDEAVOR relapsed multiple myeloma study gives Amgen's Kyprolis a leg up ahead of the entry of Velcade generics in the US this year.
Amgen Inc.is expected to get a labeling advantage for its Kyprolis in relapsed multiple myeloma after showing an overall survival benefit in the ENDEAVOR study over Takeda Pharmaceutical Co. Ltd.'s Velcade, which is set to become available in generic form in the US this year following patent expiry in May.
Amgen announced on Feb. 28 that its proteasome inhibitor Kyprolis (carfilzomib) in combination with the steroid dexamethasone demonstrated a statistically...
After presenting encouraging Phase II data on the GSK-3 inhibitor elraglusib at ASCO, Actuate Therapeutics is hoping to hold a pre-NDA meeting with the US FDA.
The go-ahead to resume a trial for its only drug candidate, zetomipzomib, in hepatitis could give Kezar a glimmer of hope of reviving another halted study in lupus nephritis.
Anselamimab was expected to complement Alexion's portfolio of amyloid therapies, but regulators will have to be convinced of its benefits to a patient subgroup in the CARES trial.
