Vytorin News and Research

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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, Gilead to jointly develop darunavir-based, single-tablet regimen for HIV treatment

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.

29 Dec 2014

FDA approves AbbVie's VIEKIRA PAK for treatment of patients with GT1 HCV infection

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.

21 Dec 2014

Adding ezetimibe to statin therapy reduces cardiovascular events

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.

18 Nov 2014

Rare gene mutation linked to lower cholesterol levels, reduced risk of heart attack

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.

14 Nov 2014

Janssen submits sNDA to FDA for simeprevir in combination with sofosbuvir for treatment of HCV genotype 1 infection

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.

8 May 2014

FDA approves OLYSIO (simeprevir) for treatment of chronic hepatitis C infection

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.

23 Nov 2013

Merck full-year 2012 worldwide sales decrease 2% to $47.3 billion

Merck, known as MSD outside the United States and Canada, today announced financial results for the fourth quarter and full year of 2012.

1 Feb 2013

U.S. District Court rules in favor of Merck over ZETIA and VYTORIN patent litigation

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.

30 Apr 2012

Merck fails to get FDA nod for new cholesterol lowering combo pill

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).

5 Mar 2012

Merck’s cholesterol lowering drug gets FDA panel’s vote

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.

3 Nov 2011

FDA EMDAC votes to recommend approval of Merck's VYTORIN for pre-dialysis CKD

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.

3 Nov 2011

Merck reports worldwide sales of $12.2 billion for second quarter 2011

Merck, known as MSD outside the United States and Canada, today announced financial results for the second quarter of 2011.

29 Jul 2011

Merck announces changes to high-dose simvastatin prescribing information in the U.S.

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.

9 Jun 2011

U.S. FDA announces safety label changes for cholesterol-lowering medication, simvastatin

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.

9 Jun 2011

Vertex receives FDA approval for INCIVEK to treat hepatitis C

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).

23 May 2011

Merck's VICTRELIS receives European CHMP positive opinion for treatment of chronic HCV genotype 1 infection

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.

20 May 2011

Merck reports GAAP net income of $861 million for 2010

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.

4 Feb 2011

VYTORIN reduces major vascular events in patients with chronic kidney disease

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)

22 Nov 2010

Surveyed cardiologists, PCPs perceive Crestor comparable to Lipitor in ability to reduce mortality

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.

20 Nov 2010

Merck reports $342 million net income for 2010 third quarter

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.

29 Oct 2010