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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

Pitavastatin may reduce risk of heart attack, stroke and death in patients with high cholesterol

Heart patients who can't tolerate the side effects of cholesterol-lowering drugs may have a new option, according to a new study by researchers from the Intermountain Heart Institute at Intermountain Medical Center in Salt Lake City.

12 Mar 2013

Lilly, Kowa announce results from PREVAIL U.S. study

Kowa Pharmaceuticals America, Inc. and Eli Lilly and Company today announced results of the PREVAIL U.S. study (Pitavastatin compaREd with praVAstatin In Lowering LDL-C in the U.S.) which evaluated the efficacy of LIVALO (pitavastatin) 4 mg compared with pravastatin 40 mg in reducing low-density lipoprotein cholesterol (LDL-C), the primary endpoint, as well as effects on other lipid parameters and lipoprotein particles in adult patients with primary hyperlipidemia or mixed dyslipidemia.

2 Jun 2012

Kowa announces data of LIVALO vs. Crestor on pharmacodynamics of warfarin

Kowa Pharmaceuticals America, Inc. today announced data assessing the effect of LIVALO (pitavastatin) compared with Crestor (rosuvastatin) on steady-state pharmacodynamics (PD) of warfarin by measuring international normalized ratio (INR) in healthy adult subjects.

14 Feb 2012

High dose peretinoin reduces recurrence of HCC after surgical resection or ablation in HCV positive patients

Kowa Company, Ltd. announced today that the results of a Phase II/III trial showed that high dose peretinoin (NIK-333) given daily for up to 96 weeks reduced the recurrence of hepatocellular carcinoma (HCC) after surgical resection or ablation in hepatitis C virus (HCV) positive patients when compared to placebo.

13 Sep 2010

Cipher Pharmaceuticals second-quarter net revenues increase to $2.2 million

Cipher Pharmaceuticals Inc. today announced its financial and operational results for the three and six months ended June 30, 2010.

28 Jul 2010

BBD reports analyze effectiveness and safety of statin use

A series of new reports from Consumer Reports Best Buy Drugs (BBD) caution that the benefits of statin use by children and some women may not outweigh the risks. Drugs to lower cholesterol - including statins - are the most commonly prescribed drugs in the U.S. and garnered more than $14 billion in sales last year.

29 Jun 2010

LIVALO for primary hyperlipidemia or mixed dyslipidemia now available in U.S.

Kowa Pharmaceuticals America, Inc., and Eli Lilly and Company today announced that LIVALO® (pitavastatin) tablets is now available in retail pharmacies throughout the United States. LIVALO, a statin medication approved by the U.S. Food and Drug Administration (FDA) in August 2009 is indicated for adults as an adjunctive therapy to diet for the treatment of primary hyperlipidemia or mixed dyslipidemia. LIVALO is available in doses of 1 mg, 2 mg and 4 mg.

21 Jun 2010

Cipher Pharmaceuticals' first-quarter total revenue up 52%

Cipher Pharmaceuticals Inc. today announced its financial and operational results for the three months ended March 31, 2010.

23 Apr 2010

Cipher Pharmaceuticals announces fourth-quarter and fiscal year 2009 results

Cipher Pharmaceuticals Inc. today announced its financial and operational results for the fourth quarter and fiscal year ended December 31, 2009.

17 Feb 2010

Eli Lilly and Kowa Pharmaceuticals America to co-promote LIVALO in the U.S

Eli Lilly and Company (NYSE: LLY), Kowa Company, Limited, and Kowa's U.S. subsidiary, Kowa Pharmaceuticals America, Inc., today announced that Lilly and Kowa Pharmaceuticals America have entered into a co-promotion agreement in the United States to commercialize LIVALO® (pitavastatin). Lilly and Kowa have also entered into a licensing agreement in Latin America. LIVALO is a statin approved by the U.S. Food and Drug Administration (FDA) in August 2009 for the treatment of primary hyperlipidemia and mixed dyslipidemia.

24 Dec 2009

LIVALO statin effective than simvastatin in reducing lipid levels

New Phase III data published today in "Current Medical Research and Opinion" highlight that the recommended starting dose of 2 mg of LIVALO (pitavastatin), a novel synthetic statin, was statistically superior to simvastatin at a dose of 20 mg over 12 weeks in reducing low-density lipoprotein cholesterol

22 Oct 2009

Combination of LIVALO and itraconazole drugs shows no adverse reactions

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2 Sep 2009

High-density lipoprotein cholesterol concentrations increased in patients treated with LIVALO

New data presented today showed that in patients treated with LIVALO (pitavastatin), high-density lipoprotein cholesterol (HDL-C) concentrations increased, and nearly three-fourths of patients attained low-density lipoprotein cholesterol (LDL-C) targets, with results sustained over 52 weeks.

2 Sep 2009

FDA approves Livalo (pitavastatin), a new cholesterol-lowering drug

The U.S. Food and Drug Administration today approved the 4 milligram maximum dose of Livalo (pitavastatin), a drug intended to improve blood cholesterol levels in persons with elevated or abnormal blood cholesterol levels.

3 Aug 2009