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Envarsus XR granted FDA orphan drug designation for prophylaxis of organ rejection in kidney transplant patients

Veloxis Pharmaceuticals A/S, today announced that Envarsus XR was granted Orphan Drug status by the U.S. Food and Drug Administration for prophylaxis of organ rejection in patients who convert from immediate-release tacrolimus. Envarsus XR received marketing authorization from the FDA on July 10, 2015.

14 Aug 2015

Instrumentation Laboratory announces European release of HemosIL Rivaroxaban Testing Solution

Instrumentation Laboratory today announced the commercialization of their HemosIL Rivaroxaban Testing Solution in Europe. The HemosIL Liquid Anti-Xa assay, when used in conjunction with HemosIL Rivaroxaban Calibrators and HemosIL Rivaroxaban controls offers an automated solution for measurement of rivaroxaban.

10 Aug 2015

Dietary phosphate appears to cause spikes in blood phosphorus levels

Phosphates artificially added to dairy and cereal products appear to cause bigger spikes in blood phosphorus levels than naturally occurring phosphates, potentially putting harmful stress on kidneys. Too much dietary phosphate stiffens blood vessels, enlarges the heart and is bad for bones, but a new study by Houston Methodist researchers suggests it matters where the phosphates come from.

22 Jul 2015

Envarsus XR receives FDA approval for treatment of kidney transplant recipients

Veloxis Pharmaceuticals A/S today announced U.S. Food and Drug Administration approval of Envarsus XR (tacrolimus extended-release tablets) for the prophylaxis of rejection in kidney transplant patients who require or desire conversion from other twice-daily tacrolimus products to once-daily Envarsus XR.

11 Jul 2015

Basilea announces UK launch of broad-spectrum Cephalosporin Zevtera for first-line treatment of pneumonia

Basilea Pharmaceutica AG today announces the UK launch of its broad-spectrum Cephalosporin Zevtera (Ceftobiprole medocaril) for the first-line treatment of serious bacterial pneumonia.

25 Jun 2015

First ESC recommendations for patients with cardiac arrhythmias, CKD published in EP Europace

The first ESC recommendations for patients with cardiac arrhythmias and chronic kidney disease (CKD) are presented today at EHRA EUROPACE - CARDIOSTIM 2015 and published in EP Europace.

24 Jun 2015

The Lancet Oncology publishes results of CYRAMZA (ramucirumab) Phase III trial for HCC treatment

Eli Lilly and Company announced that The Lancet Oncology has published results of the Phase III REACH trial that evaluated CYRAMZA (ramucirumab) as a second-line treatment for people with hepatocellular carcinoma (HCC), also known as liver cancer. While the REACH trial's primary endpoint of overall survival favored the CYRAMZA arm, it was not statistically significant.

19 Jun 2015

Combination of cobimetinib and vemurafenib can halt progression of metastatic melanoma for one year

Data from the pivotal coBRIM Phase III study, presented by Lead Investigator Dr James Larkin today at the American Society of Clinical Oncology (ASCO) annual meeting, demonstrate that Roche’s investigational MEK inhibitor cobimetinib, used in combination with BRAF inhibitor vemurafenib, typically offers people with previously untreated advanced metastatic melanoma (BRAFV600 mutation-positive unresectable or metastatic) one full year (median 12.3 months) without their disease worsening.

2 Jun 2015

Lancet Diabetes & Endocrinology to publish paper on eGFR and albuminuria for prediction of cardiovascular outcomes

The Lancet Diabetes & Endocrinology is pleased to announce that the following paper will be published to coincide with presentation at the 52nd ERA-EDTA Congress, taking place in London, UK, May 28 - 31, 2015.

1 Jun 2015

UH researchers identify new method to provide diagnostic information on kidney disease

University of Houston researchers have identified a new, less-invasive method to provide diagnostic information on kidney disease and its severity.

30 May 2015

Roche’s immunotherapy MPDL3280A better than chemotherapy in improving overall survival in NSCLC patients

Data to be presented at the 51st Annual Meeting of the American Society of Clinical Oncology suggest that the investigational immunotherapy MPDL3280A may double the likelihood of overall survival in the study period (HR=0.47), compared with docetaxel chemotherapy, in individuals with non-small cell lung cancer (NSCLC) who expressed the highest levels of PD-L1 (a receptor present on cancer cells).

30 May 2015

Measuring kidney function and damage may help predict people at risk for heart disease

Simple measures of kidney function and damage may be just as good at predicting who is at risk for heart failure and death from heart attack and stroke as traditional tests of cholesterol levels and blood pressure, new Johns Hopkins Bloomberg School of Public Health-led research suggests.

29 May 2015

Medicure records net revenue of $3.3 million for first quarter 2015

Medicure Inc., a specialty pharmaceutical company, today reported its results from operations for the first quarter ended March 31, 2015.

30 Apr 2015

Combination therapy effective in HCV patients with advanced cirrhosis and post-transplant recurrence

Phase 3 results presented today at The International Liver Congress 2015 show that a combination of daclatasvir (DCV), sofosbuvir (SOF) and ribavirin (RBV) for 12 weeks was effective and well tolerated amongst patients with hepatitis C virus (HCV) infection with advanced cirrhosis and post-transplant recurrence.

27 Apr 2015

Lilly receives fourth FDA approval for CYRAMZA (ramucirumab)

Eli Lilly and Company has received its fourth U.S. Food and Drug Administration approval for CYRAMZA (ramucirumab). CYRAMZA (ramucirumab injection 10 mg/mL solution) is now also indicated in combination with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil) chemotherapy for the treatment of patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.

25 Apr 2015

NEFIGAN Trial of Nefecon for treatment of primary IgA nephropathy meets primary endpoint

Pharmalink AB, a specialty pharma company, today announces that the NEFIGAN Trial of Nefecon for the treatment of primary IgA nephropathy has fully met its primary efficacy endpoint at a planned interim analysis and been stopped early with respect to statistical analysis of the endpoint.

14 Apr 2015

New simeprevir clinical data to be presented at EASL's International Liver Congress 2015

Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, today announced that clinical data for simeprevir, its NS3/4A protease inhibitor for the treatment of hepatitis C virus (HCV) infection, will be presented at The International Liver Congress 2015 of the European Association for the Study of the Liver taking place in Vienna from April 22-26.

8 Apr 2015

GFT505 demonstrates dose-dependent efficacy on primary endpoint in phase 2 NASH trial

GENFIT, today announces topline results of the phase 2 GOLDEN-505 trial in NASH. Due to the unexpected rate of resolution of NASH in patients randomized to placebo who had early NASH (NAS of 3, placebo response rate>57%), along with the high number of sites for a limited sample size, the study as initially designed did not enable the trial to meet directly the primary endpoint.

27 Mar 2015

Transition announces positive results from ELND005 AME and renal clearance studies

Transition Therapeutics Inc. today announced results from two phase 1 clinical studies of neuropsychiatric drug candidate ELND005. These studies, an absorption-metabolism-excretion ("AME") study and a renal clearance study, are specialized clinical pharmacology trials that are required by the United States Food and Drug Administration for the approval of most drugs in development.

26 Mar 2015

New drug fails to prevent irreversible injury to the heart after angioplasty

Patients who received the new drug Bendavia before undergoing angioplasty or receiving a stent to clear blocked arteries after a heart attack showed no significant reduction in scarring as compared to patients given a placebo, according to a study presented at the American College of Cardiology's 64th Annual Scientific Session.

18 Mar 2015