Voriconazole News and Research

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Voriconazole is a drug that treats infections caused by fungi.

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

Swapping IV medications with oral equivalents may save millions

Switching hospitalized patients able to take medication by mouth from intravenous to pill forms of the same drugs could safely save millions of dollars a year, new Johns Hopkins research suggests.

28 Oct 2011

Gilead, Bristol-Myers Squibb to develop and commercialize fixed-dose combination for HIV

Bristol-Myers Squibb Company and Gilead Sciences, Inc. today announced a licensing agreement for Bristol-Myers Squibb to develop and commercialize a fixed-dose combination containing Bristol-Myers Squibb's protease inhibitor REYATAZ (atazanavir sulfate) and Gilead's cobicistat, a pharmacoenhancing or "boosting" agent that increases blood levels of certain HIV medicines to potentially allow for one pill once daily dosing.

27 Oct 2011

Merck receives FDA approval for JUVISYNC to treat type 2 diabetes

Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved JUVISYNC(sitagliptin and simvastatin), a new treatment for type 2 diabetes that combines the glucose-lowering medication sitagliptin, the active component of JANUVIA (sitagliptin), with the cholesterol-lowering medication ZOCOR.

10 Oct 2011

Pfizer releases Phase III study results comparing VFEND-ERAXIS combination to VFEND for IA

Pfizer Inc. today reported the top-line results of an international Phase III clinical trial which compared the combination of VFEND (voriconazole) and ERAXISTM (anidulafungin) to VFEND monotherapy for primary therapy of invasive aspergillosis, a life-threatening invasive fungal infection that can develop as a complication in patients with compromised immune systems.

1 Oct 2011

Additional data on safety, tolerability of Cempra's solithromycin to be presented at 51st ICAAC

Cempra Pharmaceuticals today announced abstracts to be presented on its fourth generation macrolide and novel fluoroketolide antibiotic, solithromycin (CEM-101), at the 51st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), September 17 to 20, 2011, in Chicago. The abstracts provide additional data that demonstrate the safety and routes of administration of CEM-101, a new generation macrolide.

17 Sep 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

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

New test can diagnose deadly human fungal infections

Deadly human fungal infections caused by certain strains of Aspergillus fungi appear to be developing resistance to current drug treatments at an alarming rate, say scientists.

5 May 2011

Lead investigator to discuss growing impact of AFib on US health care costs and resources

Two studies to be presented this week address the often-overlooked costs associated with atrial fibrillation, the most common form of cardiac arrhythmia.

5 May 2011

Mylan launches generic Vfend

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has launched Voriconazole Tablets, 50 mg and 200 mg, under a previously announced settlement and license agreement with Pfizer Inc. Mylan was the first company to have filed a substantially complete ANDA containing a Paragraph IV certification for Voriconazole Tablets and was awarded 180 days of marketing exclusivity.

16 Feb 2011

SPRYCEL receives FDA approval for treating adult patients with Ph+ CML in chronic phase

After receiving a priority review, Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved SPRYCEL (dasatinib) 100 mg once daily for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.

29 Oct 2010

Gilead Sciences announces Quad regimen Phase II clinical trial results for HIV infection treatment

Gilead Sciences, Inc. today announced Phase II clinical trial results showing that its investigational fixed-dose, single-tablet "Quad" regimen of elvitegravir, cobicistat and Truvada (emtricitabine and tenofovir disoproxil fumarate) for the treatment of HIV infection maintained a high rate of virologic suppression through 48 weeks, exhibiting antiretroviral activity comparable to that of Atripla(efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg).

14 Sep 2010

FDA accepts to review sNDA for SPRYCEL for treating adult patients with CML

Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced that the U.S. Food and Drug Administration has accepted for filing and review the supplemental New Drug Application for SPRYCEL (dasatinib) for the treatment of adult patients with newly diagnosed chronic myeloid leukemia in chronic phase.

12 Jul 2010

Merck proposes to initiate Phase II proof-of-concept clinical study of posaconazole for chronic Chagas disease

Merck today announced plans to initiate a Phase II investigational proof-of-concept clinical study to evaluate its oral antifungal agent posaconazole for the treatment of chronic Chagas disease. Chagas disease results from infection with the parasite Trypanosoma cruzi that is spread by biting insects. The disease is estimated to affect approximately eight million people in Latin America, of whom approximately 30-40 percent will develop serious cardiac disease, digestive disease, or both as a result of this infection.

24 Jun 2010

Four-year follow-up results from SPRYCEL Phase 3 study in CML-CP presented at ASCO

Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced four-year follow-up results from a Phase 3 randomized, open-label, dose-optimization study of SPRYCEL® (dasatinib) in chronic-phase chronic myeloid leukemia (CML-CP) patients resistant or intolerant to Gleevec®* (imatinib mesylate). At four years, for all patients administered SPRYCEL 100 mg once daily, overall survival was 82% (95% CI: 76%-88%) and progression-free survival was 66% (95% CI: 57%-74%).

9 Jun 2010

Sanofi-aventis commences multinational Phase IIIb PALLAS trial of Multaq in permanent AF patients

Sanofi-aventis announced today the initiation of a multinational, randomized double-blind Phase IIIb trial, PALLAS, to assess the potential clinical benefit of Multaq(R) (dronedarone) in over 10, 000 patients with permanent atrial fibrillation (AF) to reduce major adverse cardiovascular events. The announcement was made during Heart Rhythm 2010, the Heart Rhythm Society's 31st Annual Scientific Sessions.

12 May 2010

New multicenter trial achieves 71% survival in AML children

More individualized therapy and better supportive care helped push the survival for children with acute myeloid leukemia (AML) to 71 percent three years after diagnosis, according to new research led by St. Jude Children's Research Hospital investigators and reported in the medical journal The Lancet Oncology. The survival rate of 71 percent is 20 percent better than previously reported U.S. rates and is similar to the success achieved in a 2009 Japanese study, said Jeffrey Rubnitz, M.D., Ph.D., a member of the St. Jude Oncology department.

11 May 2010

Gilead Sciences doses first patient in Quad Phase III clinical program

Gilead Sciences, Inc. today announced that it has dosed the first patient in the Phase III clinical program evaluating its investigational fixed-dose, single-tablet "Quad" regimen of elvitegravir, cobicistat (formerly GS 9350), emtricitabine and tenofovir disoproxil fumarate.

13 Apr 2010

Gilead Sciences’ “Quad” regimen for HIV exhibits antiretroviral activity comparable to Atripla

Gilead Sciences, Inc. announced Phase II clinical trial results today showing that its investigational fixed-dose single-tablet “Quad” regimen of elvitegravir, GS 9350 (cobicistat) and Truvada® (emtricitabine and tenofovir disoproxil fumarate) for the treatment of HIV infection exhibited antiretroviral activity comparable to that of Atripla® (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg).

18 Feb 2010