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Daily news and top headlines for drug research professionals

Agenus-GSK Lung Cancer Drug Disappoints in Trial

March 20, 2014 2:18 pm | News | Comments

Shares of Agenus tumbled more than 13% Thursday before markets opened and after the biopharmaceutical released more ineffective study results from its collaboration with GlaxoSmithKline. Read more...               

Team Proposes New Model for Clinical Trials

March 19, 2014 3:01 pm | News | Comments

Experts across academia, industry and government propose a new method for health care providers to get the right treatments to the right patients at the right time. Read more...                     

Isis Initiates Phase 1 Hyperlipidemia Drug Trial

March 19, 2014 2:41 pm | News | Comments

Isis Pharmaceuticals announced that it has initiated a Phase 1 clinical study for ISIS-ANGPTL3Rx, an antisense drug targeting angiopoietin-like 3 protein (ANGPTL3), an independent risk factor for cardiovascular disease. Read more...      

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Dartmouth, Aeras Conducting Study of New TB Vaccine

March 19, 2014 10:53 am | News | Comments

Dartmouth's Geisel School of Medicine and Aeras, a global nonprofit biotech, announced a collaboration to jointly conduct a trial of a new vaccine against tuberculosis (TB). Read more...                   

Novo Nordisk Hemophilia Drug Excels in Phase 3

March 19, 2014 10:42 am | News | Comments

Novo Nordisk announced the completion of pathfinderT2, the first Phase 3 trial with long-acting recombinant factor VIII, N8-GP (turoctocog alfa pegol) for hemophilia A patients. Read more...                  

Amgen Drug Hits Endpoint of Cholesterol Reduction

March 18, 2014 10:44 am | News | Comments

Amgen announced that the Phase 3 TESLA trial evaluating evolocumab met its primary endpoint of the percent reduction from baseline at week 12 in low-density lipoprotein cholesterol (LDL-C). Read more...              

FDA OKs Phase 2 Trial in Orphan Mitochondrial Disease

March 18, 2014 10:38 am | News | Comments

Edison Pharmaceuticals announced that the company's Investigative New Drug (IND) application to initiate "A Phase 2 Safety and Efficacy Study of EPI-743 (Vincerinone) in Children with Pearson Syndrome," was approved by the FDA. Read more... 

AstraZeneca Makes Progress on Global Brilinta Trial

March 17, 2014 3:13 pm | News | Comments

AstraZeneca announced it has completed patient enrollment approximately four months ahead of plan in the Phase 3 clinical trial EUCLID studying Brilinta (ticagrelor) tablets. Read more...                 

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Cirrhosis Drug Hits Primary Endpoints in Phase 3

March 17, 2014 2:52 pm | News | Comments

Intercept Pharmaceuticals Inc. announced that its international Phase 3 POISE trial of obeticholic acid (OCA) for the treatment of primary biliary cirrhosis (PBC) hit the primary endpoint of achieving a reduction in serum alkaline phosphatase. Read more...

Amgen's Cancer Drug Shrinks Melanoma Tumors

March 17, 2014 2:21 pm | News | Comments

Amgen announced findings from a pre-specified retrospective analysis of patients with metastatic melanoma that showed talimogene laherparepvec reduced the size of melanoma tumors. Read more...                 

First Patients Enrolled into European CKD-Associated Anemia Trial

March 17, 2014 11:05 am | News | Comments

Astellas Pharma Europe Ltd. announced that the first European patients have been enrolled into the global ALPINE program being conducted in collaboration with FibroGen Inc. to investigate the safety and efficacy of roxadustat, a potential new treatment for anemia in people with chronic kidney disease. Read more...

Medivir Presents New Phase 3 Simeprevir Data

March 17, 2014 10:39 am | News | Comments

Medivir AB announced that new Phase 3 data for the once-daily protease inhibitor simeprevir have been presented at the Conference of the Asian Pacific Association for the Study of the Liver (APASL) in Brisbane, Australia. Read more...      

New Personalized Cancer Treatment Trial Begins in UK

March 14, 2014 11:07 am | News | Comments

The first human trial of a pioneering personalized cancer treatment developed at Oxford University will begin this week, with the potential to tackle a wide range of late-stage cancers. Read more...               

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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...                 

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...                       

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...

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