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.
One week after announcing positive data from ORION-10, the second of three 19-month Phase III trials for inclisiran for lowering cholesterol, The Medicines Co. was acquired by Novartis.
Amarin Corp. Plc’s fish oil-derived drug and potential blockbuster Vascepa received a largely positive review from FDA staffers.
Amgen Inc. said starting in 2020, the drugmaker’s official list price for the cholesterol medicine Repatha will be the lower price the company began offering during 2019 to patients on Medicare and those paying for the drug out-of-pocket.
Pliant Therapeutics and Novartis reached a strategic collaboration and license deal to develop and commercialize integrin targets for liver fibrosis associated with nonalcoholic steatohepatitis (NASH).
A U.S. judge set aside a jury verdict that found Amgen Inc. patents on the company’s cholesterol drug Repatha were valid, handing a victory to Regeneron Pharmaceuticals Inc. and Sanofi SA, which sell rival drug Praluent.
The Medicines Company’s inclisiran hit the primary and secondary endpoints in a Phase III trial to decrease LDL cholesterol through twice-a-year dosing.