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Medicure records net revenue of $3.3 million for first quarter 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. [More]
Combination therapy effective in HCV patients with advanced cirrhosis and post-transplant recurrence

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. [More]
Lilly receives fourth FDA approval for CYRAMZA (ramucirumab)

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. [More]
NEFIGAN Trial of Nefecon for treatment of primary IgA nephropathy meets primary endpoint

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. [More]
New simeprevir clinical data to be presented at EASL's International Liver Congress 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. [More]
GFT505 demonstrates dose-dependent efficacy on primary endpoint in phase 2 NASH trial

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. [More]
Transition announces positive results from ELND005 AME and renal clearance studies

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. [More]
New drug fails to prevent irreversible injury to the heart after angioplasty

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. [More]
Prognostic potential for pericardial effusion in PAH patients

Prognostic potential for pericardial effusion in PAH patients

Monitoring pericardial effusion on serial transthoracic echocardiograms provides useful prognostic information in patients with pulmonary arterial hypertension, research suggests. [More]
Long-term entecavir, TDF effective in chronic HBV in real-world setting

Long-term entecavir, TDF effective in chronic HBV in real-world setting

A Turkish clinical practice study shows that entecavir and tenofovir disoproxil fumarate can effectively maintain long-term virological and biochemical responses in patients with chronic hepatitis B virus infection, both in those with and without cirrhosis. [More]
Eight clinical researchers selected as finalists for Outstanding Investigator Award at Cardiology 2015

Eight clinical researchers selected as finalists for Outstanding Investigator Award at Cardiology 2015

Pediatric cardiology researchers and clinicians from numerous centers from around the world are gathering at the Cardiology 2015: the 18th Annual Update on Pediatric and Congenital Cardiovascular Disease conference, sponsored by The Children's Hospital of Philadelphia and Phoenix Children's Hospital on Feb. 11 to Feb. 15 in Scottsdale, Ariz. [More]
Study shows changes in kidney function among sugarcane workers in northwestern Nicaragua

Study shows changes in kidney function among sugarcane workers in northwestern Nicaragua

Sugarcane workers in northwestern Nicaragua experienced a decline in kidney function during the harvest, with field workers at greatest risk, suggesting that heat stress or other occupational factors may be playing a role in the high rates of chronic kidney disease in the region, a new study led by Boston University School of Public Health researchers shows. [More]
Daiichi Sankyo receives FDA approval for SAVAYSA (edoxaban) Tablets

Daiichi Sankyo receives FDA approval for SAVAYSA (edoxaban) Tablets

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the U.S. Food and Drug Administration has approved SAVAYSA (edoxaban) Tablets, an oral, once-daily selective factor Xa-inhibitor, to reduce the risk of stroke and systemic embolism (SE) in patients with non-valvular atrial fibrillation (NVAF). [More]
Certain patients with type 2 diabetes, renal impairment discouraged from taking metformin

Certain patients with type 2 diabetes, renal impairment discouraged from taking metformin

Many patients with type 2 diabetes in the United States may be discouraged from taking metformin—a proven, oral diabetes medicine—because the U.S. Food and Drug Administration inappropriately labels the drug unsafe for some patients also suffering from kidney problems, researchers from Penn Medicine and Weill Cornel Medical College report this week in a research letter published in JAMA Internal Medicine. [More]
RCC renal function independent of axitinib-induced proteinuria

RCC renal function independent of axitinib-induced proteinuria

Treatment with the vascular endothelial growth factor receptor inhibitor axitinib does not adversely affect renal function in patients with metastatic renal cell carcinoma even in the presence of proteinuria, a Japanese study indicates. [More]
IMBRUVICA-rituximab combination well tolerated in patients with relapsed or refractory MCL

IMBRUVICA-rituximab combination well tolerated in patients with relapsed or refractory MCL

New IMBRUVICA (ibrutinib) Phase II data announced by Pharmacyclics, Inc. today demonstrates its potential utility as a combination therapy when used with rituximab. Data suggest that the overall efficacy and safety profile of IMBRUVICA is well tolerated when combined with rituximab in patients with relapsed or refractory mantle cell lymphoma (MCL). [More]
Phase 2 RESONATE-17 study: IMBRUVICA (ibrutinib) improves survival in CLL patients with del 17p

Phase 2 RESONATE-17 study: IMBRUVICA (ibrutinib) improves survival in CLL patients with del 17p

Results from the Phase 2 RESONATE-17 (PCYC-1117) study show IMBRUVICA (ibrutinib) was associated with an 82.6 percent investigator-assessed overall response rate (ORR; the primary endpoint) and a 79 percent progression-free survival (PFS) rate at 12 months in people living with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have a genetic mutation known as deletion 17p (del 17p). [More]
IMBRUVICA demonstrates anti-tumor activity against multiple myeloma in Phase II study

IMBRUVICA demonstrates anti-tumor activity against multiple myeloma in Phase II study

New IMBRUVICA (ibrutinib) Phase II data announced here today by Pharmacyclics, Inc) during the 56th American Society of Hematology Annual Meeting suggests that IMBRUVICA demonstrates anti-tumor activity both as a single-agent and as combination therapy in heavily pre-treated patients with relapsed or relapsed/refractory multiple myeloma (MM). [More]
Mylan gets tentative approval from FDA for two pediatric dosages of abacavir/lamivudine tablets

Mylan gets tentative approval from FDA for two pediatric dosages of abacavir/lamivudine tablets

Mylan Inc. today announced that its subsidiary Mylan Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration for its New Drug Applications (NDAs) for two dosages of abacavir/lamivudine tablets for oral suspension for the treatment of HIV-1 infection in pediatric patients. [More]
Alport syndrome: an interview with Dr Paul Grint, CMO, Regulus

Alport syndrome: an interview with Dr Paul Grint, CMO, Regulus

Alport Syndrome was first described by a physician called Cecil Alport, back in the late 1920s. It's a genetic disease that affects a certain type of collagen involved in the functioning of the kidney, the ear, and the eye. [More]
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