Veru Inc. and Eli Lilly and Company entered into a clinical trial collaboration and supply agreement to evaluate the efficacy and safety of enobosarm, Veru’s first-in-class, selective androgen receptor targeting agonist, in combination with Lilly’s Verzenio (abemaciclib), a CDK4/6 inhibitor, as a second line therapy in the treatment of AR+ER+HER2- metastatic breast cancer.
NIH announced Jan. 29 that “Basic Experimental Studies Involving Humans,” also called BESH, will no longer be considered clinical trials and will therefore no longer be subject to the requirements under the NIH definition of a clinical trial, including registration and reporting requirements in ClinicalTrials.gov.
