Trial data

Intercept Pharmaceuticals’ obeticholic acid (OCA) could be first drug to be approved in the US for non-alcoholic steatohepatitis (NASH), according to analysts GlobalData.  The Food and Drug Administration (FDA) accepted the company’s resubmission of its new drug application (NDA) for OCA in patients with pre-cirrhotic liver fibrosis due to NASH in December 2022.  According to […]

Greater data-centricity, supported by new technologies, is key to driving efficient product approvals and supply chains. Frits Stulp and Aida Demneri, partners at Deloitte (including Iperion – a Deloitte business), outline how life sciences companies can play their part in driving change. In the past two years, EU regulatory authorities accelerated processes so that vaccines […]

Immutep has revealed encouraging initial clinical data from two trials investigating its lead product candidate eftilagimod alpha in non-small-cell lung cancer.  Findings from the trials were shared at the Society for Immunotherapy of Cancer (SITC) Annual Meeting 2022.   The INSIGHT-003 trial is evaluating eftilagimod alpha as part of a triple combination therapy with standard-of-care anti-PD-1 […]

Psilocybin, a psychedelic derived from mushrooms, has been proven effective as a therapy for treatment-resistant depression (TRD) in the largest study of its kind.  The results of COMPASS Pathways’ Phase IIb trial have been published in The New England Journal of Medicine (NEJM).  The data show that after a single 25mg dose of COMP360 psilocybin, […]