FDA expert panel questions Daiichi Sankyo leukemia drug data ahead of meeting
A company spokesperson said the company was working to address the agency's concerns about the drug, quizartinib, for FLT3-mutated acute myeloid leukemia.
FDA lifts partial hold on Xencor leukemia study
The hold had been placed in February following two deaths in the study, including one in a patient who experienced cytokine release syndrome. The company has amended the trial protocol to mandate monitoring and management of CRS.
The Human Algorithm: What AI Can’t Replace in Pharma Engagement
At a time when AI is reshaping pharma, Reverba Global CEO Cheryl Lubbert explained in an interview why empathy, context, and ethics still require a human touch.
Astellas’s Xospata in AML scores a goal with new Phase III survival data at AACR
The drug was approved for FLT3-mutated acute myeloid leukemia in November based on response rate data, but the latest results show improvement on the gold-standard measure of overall survival.
Xencor leukemia trial put on partial hold following two patient deaths
The Phase I study is testing a bispecific antibody, XmAb14045, in acute myeloid leukemia, under a partnership with Swiss drugmaker Novartis. Xencor's stock fell following the news.
Vor Biopharma raises $42M in Series A round to advance AML cell therapy toward clinic
5AM Ventures and RA Capital Management led the round. The company is developing hematopoietic stem cells engineered to be protected from targeted immunotherapies.
Why has Jazz’s Vyxeos fallen short in sales? It may boil down to pricing and ‘politics’
The drug offers greater convenience and efficacy than the old chemotherapy combination, but its high cost and first impressions among doctors may explain why Jazz had to lower its sales guidance.
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Roche’s Venclexta data from ASH position drug as new AML standard of care, doctor says
The drug, combined with Celgene's Vidaza, Otsuka's Dacogen or low-dose cytarabine, showed strong response rates in elderly and unfit AML patients, historically a hard-to-treat population.
FDA approves Astellas’ Xospata for FLT3-mutated acute myeloid leukemia
The drug is the second FLT3 inhibitor to win approval, after Novartis' Rydapt in first-line disease. Daiichi Sankyo's quizartinib could present competition if it wins approval, but it would target a somewhat narrower population of FLT3-mutated patients.
FDA approves Agios Pharmaceuticals’ Tibsovo for acute myeloid leukemia
The approval is the latest of several drugs approved for the disease, a form of blood cancer, since last year.
Major drug partnership aims to develop new cancer drug
Under the terms of the partnership between MEI Pharma and Helsinn, the latter will develop and market the former's cancer drug targeting acute myeloid leukemia.
Solving Healthcare’s Provider Data Problem Starts with Interoperability
Break down the silos. Take control of your provider data.
Acute myeloid leukemia drugmaker closes $14.2M, focuses on personalized medicine
Tolero Pharmaceuticals, a Salt Lake City, Utah drug developer, has set its sights on ramping up the commercialization and development efforts of its acute myeloid leukemia treatment, which will enter Phase 3 trial sometime next year. The company’s fresh off of closing a Series B round of $14.2 million, though the initial aim for the […]