The industry has been eagerly awaiting the new FDA guidance on DDI studies. Last week, the draft guidance was finally released! The guidance has now been separated into in vitro drug-drug interaction studies and clinical drug interaction studies. We will be updating our popular ADME and DDI guides shortly to incorporate the changes. You can download the new guidance for in vitro DDI studies below.
Assessing genotoxicity is an integral part of the preclinical drug development process and is a regulatory requirement prior to the approval of new drugs. However, flagging genotoxic liability at this late stage is a concern and many companies are now taking a more cautious approach by testing earlier in drug discovery. To address this need, Cyprotex have developed a genotoxicity screening approach using the biomarkers pH3 and pH2AX. This approach not only identifies genotoxicity but also helps to understand the mechanism underlying the genotoxicity by differentiating between clastogens and aneugens. More information about this service is detailed below.
Metformin is the first line treatment for type 2 diabetes and, as such, is a common co-medication in patients due to the prevalence of diabetes as a comorbidity in many disease areas. Elevated plasma concentrations of metformin have been associated with lactic acidosis, and so drug-drug interactions (DDI) involving metformin are of clinical concern. In a recent publication by Elsby et al., (2017) in Pharmacology Research & Perspectives, further investigation into the mechanism behind metformin DDI is presented. You can download the publication below.
Finally, in October, our parent company, Evotec, announced yet another success in its industrial drug discovery collaborations by reaching its first milestone in its neurodegeneration alliance with Celgene. The company also announced a three year integrated drug discovery collaboration with Tesaro to discover and develop novel small molecules in the field of immuno-oncology. Find out more below.