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Daily news and top headlines for drug research professionals

Worldwide Clinical Trials to Use BioClinica’s CTMS for Global Trial Management

March 7, 2014 10:52 am | News | Comments

BioClinica Inc. announced that Worldwide Clinical Trials Inc. has selected BioClinica’s OnPoint CTMS (clinical trial management system) to support international studies spanning all phases of drug development in diverse therapeutic areas. Read more...

Novartis' Blood Cancer Drug Hits Primary Endpoint in Phase 3

March 7, 2014 9:47 am | News | Comments

Novartis announced that a pivotal Phase 3 trial of Jakavi (ruxolitinib) compared to best available therapy has met its primary endpoint of maintaining hematocrit control without the need for phlebotomy and reducing spleen size in patients with polycythemia vera resistant to or intolerant of hydroxyurea. Read more...

Investigational Drug May Up Melanoma Survival

March 6, 2014 3:11 pm | News | Comments

An experimental drug aimed at restoring the immune system's ability to spot and attack cancer halted cancer progression or shrank tumors in patients with advanced melanoma, according to a multisite, early-phase clinical trial. Read more...    


Omeros Schizophrenia Drug Pushes Through Phase 2a Trial

March 6, 2014 3:01 pm | News | Comments

Omeros Corp. announced additional positive results from a Phase 2a clinical trial of OMS824, the company's phosphodiesterase 10 (PDE10) inhibitor. Read more...                          

Boehringer Ingelheim Combo Treatment Excels Against HIV, HCV

March 6, 2014 7:25 am | News | Comments

Boehringer Ingelheim announced results from the Phase 3 STARTVerso4 trial in patients with HCV/HIV co-infection. Hepatitis C viral cure 12 weeks after the conclusion of treatment (SVR12) was achieved by 72% of all patients in the trial. Read more...

Clinical Study in the Czech Republic Confirms Blood-based Septin9 Test as Alternative for CRC Screening

March 5, 2014 9:45 am | News | Comments

Epigenomics, the German-American cancer molecular diagnostics company, announced findings from a study executed in different centers in Prague, Pilsen, and Brno. According to the study, in late 2013 blood-based Septin9 testing could be an attractive screening alternative to established methods for a population that would otherwise be non-compliant to colorectal cancer screening.

Lebrikizumab Phase 2b Data Show Reduction of Asthma Attack Rates

March 5, 2014 9:38 am | News | Comments

Roche presented new data from the LUTE / VERSE Phase 2b studies investigating lebrikizumab in patients with severe uncontrolled asthma. The data showed that asthma attacks were reduced by 60 percent in lebrikizumab-treated patients with a high level of the biomarker periostin, compared to only 5 percent in patients with a low level of periostin.

Immune System-based Therapy Produces Lasting Remissions in Melanoma Patients

March 4, 2014 2:06 pm | News | Comments

A drug that unleashes the immune system to attack cancer can produce lasting remissions and hold the disease in check – for more than two years, in some cases – in many patients with advanced melanoma, according to a new study that provides the longest-term look so far at how melanoma patients have fared since receiving the drug, nivolumab, in a Phase 1 clinical trial.


Asthma Drug Aids Simultaneous Desensitization to Food Allergies

February 28, 2014 1:16 pm | News | Comments

An asthma drug accelerates the process of desensitizing patients with food allergies to several foods at the same time, according to a new study. Read more...                           

Pacira Nerve Block Trial Hits Phase 3 Endpoint

February 27, 2014 2:03 pm | News | Comments

Pacira Pharmaceuticals Inc. announced that the Phase 3 clinical trial assessing the safety and efficacy of Exparel in femoral nerve block for total knee arthroplasty met its primary efficacy endpoint. Read more...           

Eisai Launches Phase 3 Breast Cancer Trial

February 27, 2014 12:47 pm | News | Comments

Eisai Inc. announced the start of a large, randomized Phase 3 trial to compare the efficacy, safety and tolerability of eribulin mesylate to standard weekly paclitaxel as a first- or second- line treatment for HER2-negative locally recurrent or metastatic breast cancer. Read more...

Dyax HAE Drug Pushes Through Phase 1

February 26, 2014 3:06 pm | News | Comments

Dyax Corp. announced positive results from the first-in-human clinical study of their investigational product, DX-2930. Read more...                                 

K-PAX Pharma, Stanford Collaborate on Chronic Fatigue Trial

February 26, 2014 2:36 pm | News | Comments

K-PAX Pharmaceuticals is working with Stanford University and several other leading research institutions to perform a Phase 2, double-blind, placebo-controlled trial to identify a safe and effective treatment for the chronic fatigue and decreased alertness that commonly afflicts people with CFS. Read more...


DelMar Posts Updated Glioblastoma Trial Results

February 26, 2014 11:02 am | News | Comments

DelMar Pharmaceuticals Inc. provided an update on the company's ongoing Phase I/II clinical trial for VAL-083 in recurrent glioblastoma, announcing that the company has now begun enrollment for Cohort 6 of the trial. Read more...      

Novartis Extends Trial Data Transparency

February 26, 2014 10:45 am | News | Comments

Novartis announced that to extend clinical trial data transparency, the company will now provide patient-level data on newly approved innovative medicines to those researchers who request it. Read more...           

InterMune Considers NDA Submission after Positive Lung Drug Trial

February 25, 2014 2:55 pm | News | Comments

InterMune Inc. announced that top-line data from a Phase 3 trial evaluating pirfenidone in patients with idiopathic pulmonary fibrosis (IPF) demonstrated a significant reduction in IPF disease progression. Read more...          

Lilly Diabetes Drug Hits Late-Stage Goal

February 25, 2014 11:10 am | News | Comments

Eli Lilly and Co.'s experimental injectable diabetes treatment dulaglutide fared on par in a late-stage study with another drug that's already on the market. Read more...                       

FDA OKs Label Update for Pfizer's Xeljanz

February 25, 2014 10:31 am | News | Comments

Pfizer Inc. announced that the FDA has approved a supplemental New Drug Application to update the current label of Xeljanz 5 mg tablets to include radiographic data from two Phase 3 studies. Read more...             

Isis Pharmaceuticals SMA Drug Excels in Phase 2

February 24, 2014 2:14 pm | News | Comments

Isis Pharmaceuticals Inc. provided an update on its ongoing open label, multiple dose, Phase 2 study of ISIS-SMNRx in infants with spinal muscular atrophy (SMA). Read more...                     

Pfizer Vaccine Prevents Pneumonia in Older Adults

February 24, 2014 12:46 pm | News | Comments

Pfizer Inc. today announced that the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA) achieved its primary clinical objective and both secondary clinical objectives. Read more...               

Omega 3, Antidepressants May Curb Dementia Symptoms

February 24, 2014 10:54 am | News | Comments

A new study is looking into the effectiveness of omega-3 supplements and the antidepressant, sertraline, in reducing depressive symptoms and cognitive decline in older people, in a bid to prevent the onset of depression and dementia in later life. Read more...

Eisai to Launch New, Global Belviq Trial

February 24, 2014 10:25 am | News | Comments

Eisai Inc. announced that patient recruitment and enrollment are currently underway for a randomized double-blind, placebo-controlled outcomes trial to evaluate the effect of long-term treatment with Belviq on the incidence of major adverse cardiovascular events and new onset type 2 diabetes mellitus. Read more...

Subanalysis Shows Consistent Results for Eliquis versus Warfarin

February 21, 2014 2:21 pm | News | Comments

Bristol-Myers Squibb Co. and Pfizer Inc. announced results of a pre-specified subanalysis of the Phase 3 ARISTOTLE trial in relation to patient age. Read more...                         

Janssen Initiates Phase 3 Study to Slow Diabetic Nephropathy

February 21, 2014 10:45 am | News | Comments

Janssen Research & Development LLC announced the initiation of CREDENCE, a global, multicenter study of Invokana in patients with type 2 diabetes and diabetic nephropathy. Read more...                 

Antares Posts Positive Results from Testosterone Study

February 20, 2014 2:57 pm | News | Comments

Antares Pharma Inc. announced positive results from a multi-center Phase 2 clinical study evaluating the pharmacokinetic profile of testosterone enanthate in testosterone deficient adult males. Read more...              

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