Swiss drugmaker Novartis grabbed a key European panel’s recommendation for Leqvio, clearing the way for the prospective cholesterol drug’s approval in the next couple of months.
The U.S. Food and Drug Administration accepted Copenhagen, Denmark-based Orphazyme’s New Drug Application (NDA) for arimoclomol for the treatment of Niemann-Pick disease Type C.
Novartis announced results from a post-hoc analysis of pooled data from the Phase III ORION-10 and -11 trials evaluating the individual responses of patients on low-density lipoprotein cholesterol (LDL-C) reduction with inclisiran, a first-in-class investigational treatment for hyperlipidemia in adults.
The U.S. Justice Department charged Teva Pharmaceutical Industries Ltd. with conspiring with competitors to raise prices for generic drugs.
Investment firm Blackstone Life Sciences and Alnylam Pharmaceuticals announced a broad strategic collaboration worth up to $2 billion.
The U.S. Food and Drug Administration approved Ann Arbor, Michigan-based Esperion’s Nexlizet (bempedoic acid and ezetimibe) for lowering LDL cholesterol.
The U.S. Food and Drug Administration approved Michigan-based Esperion’s oral, once-daily, non-statin LDL-cholesterol lowering medicine Nexletol (bempedoic acid).
MedAdNews spoke to Bill Dreitlein, Senior Director, Pipeline & Drug Surveillance at OptumRx, about the state of the industry’s prescription drug pipeline and what enticing prospects will soon emerge.
AstraZeneca said on Monday the company will discontinue a late-stage trial for the heart disease drug Epanova to treat patients with mixed dyslipidemia and expects a $100 million writedown to hit its core profit in the fourth quarter.
AstraZeneca announced that after a recommendation from an independent Data Monitoring Committee, the company was abandoning the Phase III STRENGTH trial for Epanova (omega-3 carboxylic acids) for mixed dyslipidemia. Acasti Pharma’s Phase III TRILOGY 1 trial for the fish oil-based candidate CaPre (omega-3 phospholipid) for severe hypertriglyceridemia did not reach statistical significance.