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Celgene and Agios Pharmaceuticals have won FDA approval for an acute myeloid leukemia (AML) treatment intended for patients with specific mutations of the isocitrate dehydrogenase 2 (IDH2) gene. Idhifa (enasidenib) is an IDH2 inhibitor approved yesterday as a treatment for adults with relapsed or refractory AML who show IDH2 mutations in blood or bone marrow samples following use of a companion diagnostic, Abbott Laboratories’ RealTime IDH2 Assay. While Celgene received the formal FDA approval, the biotech giant has worked with Agios over seven years to develop Idhifa, previously known as AG-221 and CC-90007. Idhifa is the first development candidate developed through the first of several collaborations between the companies, launched in April 2010. Celgene offered $130 million upfront, including an equity investment, for rights to co-develop an unspecified number of drugs discovered through Agios’ cancer metabolism research platform, based on the concept of “starving” cancer by ...
Original Article: FDA Approves Celgene/Agios AML Treatment IdhifaNEXT ARTICLE
In order to become availible to pateints, drugs need to undergo a number of phases of clinical trials to test their efficacy and safty and to then be authorised by the drug approval organistion in each respective country. This is the FDA in the USA and N...
Leukemia is a type of cancer of the blood or bone marrow characterized by an abnormal increase of immature white blood cells called "blasts". Leukemia is a broad term covering a spectrum of diseases. In turn, it is part of the even broader grou...
Bioinformatics is the application of computer software and hardware to the management of biological data to create useful information. Computers are used to gather, store, analyze and integrate biological and genetic information which can then be applied...