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Daily news and top headlines for drug research professionals

Bayer Kicks Off Phase 3b Riociguat Trial in PAH Patients

March 14, 2014 10:53 am | News | Comments

Bayer HealthCare announced the enrollment of the first patient in a Phase 3b pilot study, RESPITE, designed to evaluate the clinical effects of riociguat in patients with pulmonary arterial hypertension who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors. Read more...

Newly Discovered Heart-Failure Culprit Can Be Blocked

March 13, 2014 3:08 pm | News | Comments

A team of researchers have identified a small but powerful new player in the onset and progression of heart failure. Their findings also show how they successfully blocked the newly discovered culprit to halt the debilitating and chronic life-threatening condition in its tracks. Read more...

GSK Completes Recruitment in New COPD Study

March 13, 2014 9:17 am | News | Comments

GlaxoSmithKline plc and Theravance Inc. announced that recruitment of patients into the “Study to Understand Mortality and MorbidITy,” known as SUMMIT, has completed enrollment. Read more...                 

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Pfizer Trial Shows Drug Prevents Community-Acquired Pneumonia

March 12, 2014 3:17 pm | News | Comments

Pfizer Inc. presented detailed results of CAPiTA, demonstrating that Prevenar 13 prevented a first episode of vaccine-type community-acquired pneumonia (CAP) in adults 65 years of age and older, the study’s primary objective. Read more...    

Chimerix Gets OK for Brincidofovir Pilot Trial, Gives Drug to Sick Boy

March 12, 2014 3:00 pm | News | Comments

Chimerix Inc. announced that it has reached agreement with the FDA for the immediate initiation of a pilot trial of open-label brincidofovir for the treatment of adenovirus infections in immunocompromised patients. Josh Hardy, whose story brought public attention to adenovirus infection, will be the first person enrolled. Read more...

Study Questions Accepted Treatment for Prostate Cancer

March 12, 2014 2:13 pm | News | Comments

Contrary to the standard approach to treating metastatic prostate cancer, direct treatment of the primary tumor appears to prolong survival significantly, a new study suggests. Read more...                 

FDA Halts Geron's Imetelstat Development

March 12, 2014 1:46 pm | News | Comments

Geron Corp. announced that its Investigational New Drug (IND) application for imetelstat has been placed on full clinical hold by the FDA, affecting all ongoing company-sponsored clinical trials. Read more...            

Senesco Launches New Cancer Trials in South Africa

March 12, 2014 11:19 am | News | Comments

Senesco Technologies Inc. reported the opening of two new sites in the Republic of South Africa at Pretoria East Hospital and Groote Schuur Hospital in Cape Town. Read more...                       

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Rexahn Announces Initial Results from Phase 1 Trial of Supinoxin for Solid Cancer Tumors

March 11, 2014 3:08 pm | News | Comments

Rexahn Pharmaceuticals, Inc. announced initial data for the Phase 1 dose-escalation clinical trial of Supinoxin (RX-5902) initiated in August 2013. This trial was designed to study safety and efficacy in patients with solid cancer tumors. The study is still ongoing and the maximal tolerated dose (MTD) has not yet been achieved.

Bayer and Onyx Report Phase 3 Study Results of NEXAVAR

March 11, 2014 3:00 pm | News | Comments

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, an Amgen subsidiary, announced that a Phase 3 trial evaluating the investigational use of NEXAVAR (sorafenib) tablets as an adjuvant treatment for patients with hepatocellular carcinoma (HCC), or liver cancer, who had no detectable disease after surgical resection or local ablation, did not meet its primary endpoint of improving recurrence-free survival.

Omeros Announces Positive Data from Phase 2 aHUS Drug Trial

March 10, 2014 2:32 pm | News | Comments

Omeros Corp. announced positive data using OMS721 in ex vivo studies of endothelial activation relevant to the pathophysiology of human atypical hemolytic uremic syndrome (aHUS), a form of thrombotic microangiopathy (TMA). Read more...     

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...

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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...      

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