Servier drug Tibsovo is now approved for treating advanced cases of myelodysplastic syndrome that have an IDH1 mutation. It’s the first approval of a targeted therapy for this type of cancer.
Bristol Myers Squibb drug Reblozyl is now approved as a first-line therapy for anemia caused by myelodysplastic syndromes, a group of blood cancers. It’s the third indication for the drug, which analysts project could top $4 billion in peak sales.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
An Eisai drug that produced disappointing data in a myelodysplastic syndrome study is getting another shot under a newly launched Roivant Sciences subsidiary, Hemavant. Roivant executives say the small molecule could be a safer, more effective alternative to MDS therapies marketed by Bristol Myers Squibb.
The companies said the FDA's Oncologic Drugs Advisory Committee would review their application for Reblozyl in myelodysplastic syndrome. The drug, which won approval for a blood disorder last month, was developed under a partnership between Acceleron and Celgene, which BMS has since acquired.
The feasibility study was meant to see whether personalized cancer genetic sequencing and drug sensitivity recommendations could be done in a "clinically reasonable amount of time."
Approval of luspatercept in myelodysplastic syndrome and beta-thalassemia is expected in April 2020, or as early as December of this year if it receives FDA priority review, an analyst wrote.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.