BioSpace sat down with Katy Powell, a psychiatric mental health nurse practitioner in Portland, Oregon, to discuss the relative risks and benefits associated with psychedelic-assisted therapy.
Intercept Pharmaceuticals said it would resubmit its application for nonalcoholic steatohepatitis (NASH) treatment to the U.S. Food and Drug Administration based on new interim analysis of data from an ongoing late-stage study. The company is seeking approval for obeticholic acid to treat fibrosis or scarring associated with NASH, a serious progressive liver disease caused by excessive fat accumulation in the liver.
Leaderboard Branding, a Fingerpaint company – the fast-growing global naming and branding firm that delivers strategic insights and world-class creativity to biopharma and healthcare companies as early as clinical phase 1 – announced the hiring of Max Straka, PharmD, FISMP, a former FDA Division of Medication Error Prevention and Analysis (DMEPA) safety evaluator. As a Director of Leaderboard Branding’s Drug Safety Division, Dr. Straka adds to the broad experience of global leaders and innovators in this important area of drug development.
Pharmacovigilance, the industry term for drug safety, was unfamiliar to most of the general public before March 2020. But as the coronavirus pandemic unfolded, its rapid spread thrust drug safety into the spotlight. The public is more aware of drug safety and health regulators’ role than ever — and as the demand for pharmacovigilance information rises, the industry has had to find ways to keep up — according to Beena Wood, VP of safety at ArisGlobal.