Vytorin is one tablet that combines two cholesterol-lowering drugs-simvastatin (Zocor), a statin made by Merck & Co., and ezetimibe (Zetia), made by Schering-Plough Pharmaceuticals-to help lower bad cholesterol (low-density lipoprotein, or LDL) further. Simvastatin works in the liver to prevent the formation of cholesterol (as do all statin medications), while ezetimibe works by preventing the absorption of cholesterol from the intestine.
Janssen R&D Ireland announced today an amendment to its existing agreement with Gilead Sciences, Inc., initially established in 2011, for the development of a once daily, darunavir-based, single-tablet regimen (STR) for the treatment of people living with HIV.
The U.S. Food and Drug Administration has approved AbbVie's VIEKIRA PAK, an all-oral, interferon-free treatment, with or without ribavirin (RBV), for the treatment of patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection, including those with compensated cirrhosis.
More than a decade ago, researchers from Brigham and Women's Hospital demonstrated that a high dose statin, which lowered cholesterol further than a regular dose statin, provided better clinical outcomes. But questions remained about whether further reducing cholesterol would be even more effective in reducing cardiovascular-related events.
Rare mutations that shut down a single gene are linked to lower cholesterol levels and a 50 percent reduction in the risk of heart attack, according to new research from Washington University School of Medicine in St. Louis, the Broad Institute at Massachusetts Institute of Technology and Harvard, and other institutions.
Janssen Research & Development, LLC (Janssen) today announced it has submitted a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for simeprevir, an NS3/4A protease inhibitor marketed as OLYSIO™ in the United States, in combination with the nucleotide analog NS5B polymerase inhibitor sofosbuvir developed by Gilead Sciences, Inc.
Janssen Therapeutics, Division of Janssen Products, LP, announced today the U.S. Food and Drug Administration has approved OLYSIO (simeprevir), an NS3/4A protease inhibitor, for the treatment of chronic hepatitis C infection as part of an antiviral treatment regimen in combination with pegylated interferon and ribavirin in genotype 1 infected adults with compensated liver disease, including cirrhosis.
Merck, known as MSD outside the United States and Canada, today announced financial results for the fourth quarter and full year of 2012.
Merck, known as MSD outside the United States and Canada, announced today that the U.S. District Court for the District of New Jersey has ruled in Merck's favor in two jointly related patent infringement suits against Mylan Pharmaceuticals Inc.
The length of delay in approval is not clear yet as the FDA has called for additional study data on the compound. It combines generic Lipitor (Atorvastatin), the top-selling drug of all time, with Merck's cholesterol medicine Zetia (Ezetimibe).
A health advisors’ panel have unanimously backed the use of Merck & Co's cholesterol-lowering drug Vytorin for preventing stroke and other heart problems in patients with chronic kidney disease, but only in those patients not yet on dialysis. The panel voted 16-0 during a meeting today in Silver Spring, Maryland.
Merck, known as MSD outside the United States and Canada, announced today that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) unanimously voted to recommend approval of Merck's VYTORIN (ezetimibe/simvastatin) for use in patients with pre-dialysis chronic kidney disease.
Merck, known as MSD outside the United States and Canada, today announced financial results for the second quarter of 2011.
Merck, known as MSD outside the United States and Canada, today announced changes to the prescribing information in the United States for the highest dose of simvastatin, 80 mg, and the use of simvastatin with certain other medicines.
The U.S. Food and Drug Administration today is announcing safety label changes for the cholesterol-lowering medication simvastatin because the highest approved dose--80 milligram (mg)--has been associated with an elevated risk of muscle injury or myopathy, particularly during the first 12 months of use.
Vertex Pharmaceuticals Incorporated announced that the U.S. Food and Drug Administration (FDA) has approved INCIVEK™ (telaprevir) tablets for a broad group of people with genotype 1 chronic hepatitis C with compensated liver disease (some level of damage to the liver but the liver still functions), including cirrhosis (scarring of the liver).
Merck, today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion under accelerated assessment recommending approval of the investigational medicine VICTRELIS (boceprevir) for the treatment of chronic hepatitis C virus genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.
Merck, known as MSD outside the United States and Canada, today announced financial results for the fourth quarter and full year of 2010. The company reported non-GAAP (generally accepted accounting principles) earnings per share (EPS) for the fourth quarter of $0.88, which excludes purchase accounting adjustments, restructuring costs and merger-related expenses.
In a new investigational study of VYTORIN, the cholesterol-lowering medicine from Merck, VYTORIN 10/20 mg reduced the incidence of first major vascular events defined as non-fatal heart attacks or cardiac death, stroke or any revascularization procedure by a highly statistically significant 16.1 percent compared to placebo, Study of Heart and Renal Protection study involved more than 9,000 patients who, on average, had advanced or end-stage chronic kidney disease (CKD)
Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that in the treatment of dyslipidemia, surveyed cardiologists and primary care physicians (PCPs) now perceive AstraZeneca's Crestor's ability to reduce mortality comparable to Pfizer's Lipitor. This finding has changed from Decision Resources' 2009 analysis in which surveyed cardiologists viewed Lipitor as significantly better on this end point.
Merck & Co., Inc. today announced financial results for the third quarter of 2010. The company reported non-GAAP (generally accepted accounting principles) earnings per share (EPS) for the third quarter of $0.85, which excludes purchase accounting adjustments, restructuring costs, merger-related expenses and a $950 million legal reserve.