Health Canada Issues Recall of IDHIFA (enasidenib mesylate)
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol Myers Squibb (NYSE:BMY) today announced that the Phase 3 IDHENTIFY study evaluating IDHIFA® (enasidenib) plus best supportive care (BSC) versus conventional care regimens, which include best supportive care (BSC) only, azacitidine plus BSC, low-dose cytarabine plus BSC or intermediate-dose cytarabine plus BSC, did not meet the primary endpoint of overall survival (OS) in patients with relapsed or refractory acute myeloid leukemia (R/R AML) with an isocitrate dehydrogenase-2 (IDH2) mutation. The safety profile of IDHIFA was consistent with previously reported findings. The company will complete a full evaluation of the IDHENTIFY data and work with investigators to present detailed results at a future medical meeting.
Back in 2017, the FDA cleared Celgene's acute myeloid leukemia therapy Idhifa based on complete remission data. But fast forward to today, and the drug has chalked up a clinical failure that shows it doesn't actually extend lives.
Agios Pharmaceuticals on Friday announced a marketing deal worth hundreds of millions of dollars, as well as positive data from two studies of a closely watched experimental medicine the company is developing for several blood diseases.
CHICAGO (Reuters) - When Medicare prescription drug insurance was created in 2003, the idea that beneficiaries with very high drug costs should pick up 5 percent of the tab seemed reasonable - but that was well before specialty drugs were invented that carry price tags in the tens of thousands of dollars.
A year after its Celgene-partnered drug Idhifa won FDA approval to treat certain patients with relapsed/refractory acute myeloid leukemia, Agios Pharmaceuticals has scored its first FDA nod for a wholly-owned medicine, Tibsovo.
Agios has hit another big goal in its decade-long track record. The FDA today signaled the accelerated approval of ivosidenib (AG-120) for advanced acute myeloid leukemia.
When Mark Alles got the big promotion to CEO of Celgene $CELG two years ago, the company was a widely admired big biotech which had committed large portions of its revenue to building a pipeline through some of the most intense dealmaking activities in the industry. Today, its stock price is badly banged up, its whole pipeline strategy is in doubt and some analysts are starting to give some careful attention to determining what’s gone wrong.