?Althera Pharmaceuticals, a maker of cardiovascular medications, is in the FDA crosshairs for its flagship cholesterol oral delivery drug Roszet. The drug, which combines two standard cholesterol treatments in one pill, is under the FDA Office of Prescription Drug Promotion’s spyglass for promotional claims around the product’s efficacy and risk.
The Court of Appeal (CoA) has dismissed appeals involving Irish pharmaceutical manufacturer Clonmel Healthcare and international giant Merck Sharp and Dohme (MSD) in a patent rights row over a cholesterol-reducing drug.
Novartis on Wednesday won Food and Drug Administration approval for a genetic drug that can powerfully lower cholesterol with just two injections a year, one that it hopes could be widely used to lower the risk of heart disease complications.
Amgen wants the U.S. Supreme Court to reverse the Federal Circuit's decision to invalidate two patents covering the company's PCSK9 cholesterol med Repatha, the company said in a petition to the court.
The Subject Expert Committee (SEC), under the Central Drugs Standard Control Organisation (CDSCO), has refused to waive off the local clinical trial for Novartis Healthcare’s cholesterol lowering drug inclisiran injection. The Committee sought the company to conduct phase III clinical trials and submit the data.
The layoffs will take place across the board, from sales and marketing to R&D, CEO Sheldon Koenig told Endpoints News on Monday. While the chief executive declined to elaborate on how many employees will be affected, an SEC filing stated that approximately 170 staffers are on the chopping block.
FDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancy; still advises most pregnant patients should stop taking statins
CONSHOHOCKEN, Pa., July 13, 2021 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) announced today its first patient dosed in a planned 52-week open label active treatment extension study of MAESTRO-NAFLD-1, named MAESTRO-NAFLD-1-Open Label Extension (OLE) (NCT04951219). MAESTRO-NAFLD-1 is an ongoing 52-week ~1200 patient Phase 3 non-invasive, multi-center, double-blind, randomized, placebo-controlled study of resmetirom in patients with non-alcoholic fatty liver disease (NAFLD), presumed NASH. The study is due to complete later this year with measures of safety and efficacy including reduction in imaging and biomarker measures of NASH, as well as the lowering of LDL-cholesterol and other atherogenic lipids.
An increase in number of people with cholesterol and triglyceride abnormalities is set to drive the global dyslipidemia drugs market forward. A major factor driving the incidence of these abnormalities is modern lifestyle - marked by obesity due to lack of exercise and poor dietary habits.