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Daily news and top headlines for drug research professionals

Chagas Disease Drug Candidate Hits Phase 2

August 13, 2014 2:27 pm | Videos | Comments

The Drugs for Neglected Diseases initiative announced the launch of a Phase 2 drug trial to test fexinidazole, a drug shelved in the 1980s and "rediscovered" by DNDi nearly a decade ago, for Chagas disease (American trypanosomiasis) patients. Read more...

Epizyme Presents Early-Phase Data on Cancer Drug

August 13, 2014 11:24 am | News | Comments

Epizyme Inc. reported pre-clinical data and early clinical observations from an ongoing Phase 1 trial, being conducted in collaboration with Eisai, the Institut Gustave Roussy, and the Institut Bergonie, of EZH2 inhibitor EPZ-6438 (E7438) in patients with advanced solid tumors and B-cell lymphomas. Read more...

AstraZeneca’s Gout Drug Achieves Positive Results

August 13, 2014 11:12 am | News | Comments

AstraZeneca announced positive top-line results from CLEAR1, CLEAR2 and CRYSTAL, the pivotal Phase 3 clinical trials investigating the potential of lesinurad, a selective uric acid re-absorption inhibitor (SURI), as a combination therapy for the treatment of patients with symptomatic gout. Read more...

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Pfizer Posts Mixed Results from Chinese Lyrica Studies

August 13, 2014 11:08 am | News | Comments

Pfizer Inc. announced top-line results from two placebo-controlled studies conducted in China with Lyrica (pregabalin) in patients with postherpetic neuralgia (pain after shingles or PHN) and painful diabetic peripheral neuropathy (pDPN), respectively. Read more...

MJFF Highlights Promising Parkinson's Disease Drug Research

August 12, 2014 3:21 pm | News | Comments

Research projects from five groups active in Parkinson's research comprise the 2014 first half (1H 2014) of The Michael J. Fox Foundation for Parkinson's Research (MJFF) Partnering Program. Read more...                

Clinical Trial Evaluates Safety of Stem Cell Transplantation in Spine

August 12, 2014 2:41 pm | Videos | Comments

Researchers have launched a clinical trial to investigate the safety of neural stem cell transplantation in patients with chronic spinal cord injuries. This Phase 1 clinical trial is recruiting eight patients for the five-year study. Read more...

Cortendo Enrolls First Patient into Cushing’s Study

August 12, 2014 11:43 am | News | Comments

Cortendo AB announced that the first patient has been enrolled into the Phase 3 SONICS trial, i.e., “Study of NormoCort in Cushing’s Syndrome,” after successfully completing its European Investigator meeting supporting SONICS. Read more...

Prosensa, CureDuchenne Strengthen Collaboration

August 12, 2014 11:38 am | News | Comments

Prosensa Holding N.V. announced that an affiliate of CureDuchenne will provide Prosensa with up to €5 million by means of convertible promissory notes to support the company and accelerate the development and patient access of much needed DMD therapies. Read more...

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Intercept Liver Drug Excels in Trial

August 12, 2014 9:21 am | News | Comments

Shares of Intercept Pharmaceuticals Inc. soared in premarket trading Tuesday, a day after the drug developer said its most advanced candidate performed better than a placebo in a mid-stage study of patients with a form of chronic liver disease. Read more...

Regulators Approve Glioblastoma Study Enhancements

August 11, 2014 2:46 pm | News | Comments

Northwest Biotherapeutics announced that, following a 9-month process of regulatory submissions and reviews by regulators in the US, UK and Germany, it has obtained regulatory approvals to make certain enhancements to its ongoing Phase 3 clinical trial of DCVax-L Glioblastoma multiforme (GBM) brain cancer. Read more...

TPM/Oxymorphone Patch Demonstrates Reproducibility

August 11, 2014 10:53 am | News | Comments

Australian drug delivery company, Phosphagenics Ltd. announced that the first of its additional studies designed to further characterize the TPM/Oxymorphone patch, in support of an Investigational New Drug (IND) application with the FDA has been completed. Read more...

Avillion Doses First Patients in Leukemia Drug Trial

August 11, 2014 10:49 am | News | Comments

Avillion LLP announced that the first patients have been dosed in the United States in a global Phase 3 clinical trial called "BFORE," which is designed to assess the effectiveness and safety of Bosulif as a first-line treatment for patients with chronic phase Philadelphia chromosome positive chronic myelogenous leukemia. Read more...

Genentech Submits sBLA for Diabetic Retinopathy Drug

August 8, 2014 3:21 pm | News | Comments

Genentech, a member of the Roche Group, announced that the company has submitted a supplemental Biologics License Application for Lucentis (ranibizumab injection) to the U.S. Food and Drug Administration for the treatment of diabetic retinopathy. Read more...

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Neurovance Completes Enrollment in Abuse Liability Study

August 8, 2014 3:05 pm | News | Comments

Neurovance Inc. announced that it has completed enrollment in a human abuse liability study of centanafadine (formerly EB-1020), a novel non-stimulant being developed for the treatment of adults with attention deficit hyperactivity disorder (ADHD). Read more...

EMA Accepts Application for New Pneumococcal Vaccine Indication

August 8, 2014 10:41 am | News | Comments

Pfizer Inc. announced that the European Medicines Agency has accepted Pfizer’s application seeking to expand the indication for Prevenar 13 in adults to include the prevention of pneumonia caused by the 13 pneumococcal serotypes contained in the vaccine. Read more...

FDA Lifts Hold on Tekmira’s Experimental Ebola Drug

August 8, 2014 9:55 am | by Matthew Perrone, AP Health Writer | News | Comments

U.S. health authorities have eased safety restrictions on an experimental drug to treat Ebola, a move that could clear the way for its use in patients infected with the deadly virus, prompting praise by Tekmira's CEO Mark Murray on Thursday. Read more...

Study Correlates Immune Response, Improved Survival in Prostate Cancer

August 7, 2014 10:58 am | News | Comments

Generex Biotechnology Corp. announced publication of a follow-up study from a Phase 1 clinical trial of the immunotherapeutic agent AE37 in patients with prostate cancer that demonstrates an association between a specific immune response generated by AE37 and improved overall survival. Read more...

Last Patient Completes Oramed Oral Insulin Trial

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

Oramed Pharmaceuticals Inc. reported that the last patient has completed treatment in its Phase 2a clinical trial of ORMD-0801, the company's proprietary oral insulin capsule, to treat type 1 diabetes, and top-line data is expected to be reported in the fourth quarter of 2014. Read more...

Health Canada Approves Abraxane, Gemcitabine for Pancreatic Cancer

August 7, 2014 10:39 am | News | Comments

Health Canada has approved Abraxane for Injectable Suspension (paclitaxel powder for injectable suspension) (nanoparticle, albumin-bound [nab] paclitaxel) for first-line treatment of adult patients with metastatic pancreatic cancer. Read more...

BDSI Reports 'Encouraging' Results from Phase 3 Analysis

August 6, 2014 3:31 pm | News | Comments

BioDelivery Sciences International Inc. announced that it has completed a pre-specified interim analysis of the ongoing initial pivotal Phase 3 trial for Clonidine Topical Gel for the treatment of painful diabetic neuropathy (PDN). Read more...  

Oxygen, Imperial College London Collaborate on Organ Failure Trial

August 6, 2014 10:56 am | News | Comments

Oxygen Biotherapeutics Inc. announced a collaboration with Imperial College London to provide supplemental funding to support the accelerated enrollment and completion of the ongoing LeoPARDS Trial awarded by the Efficacy and Mechanism Evaluation Programme and funded by the Medical Research Council and managed by the National Institute for Health Research. Read more...

Psoriasis, RA Drug Shows Good Efficacy

August 6, 2014 10:45 am | News | Comments

Can-Fite BioPharma Ltd., a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, announced new data from a retrospective analysis of its autoimmune disease advanced trials that shows high efficacy of its orally bioavailable drug CF101. Read more...

EU Approves Avastin for Ovarian Cancer

August 6, 2014 10:24 am | News | Comments

Roche announced that the European Commission approved the use of Avastin (bevacizumab) in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin chemotherapy as a treatment for women with recurrent ovarian cancer that is resistant to platinum-containing chemotherapy. Read more...

Paclitaxel Reformulated for Bolus Intraperitoneal Injection

August 5, 2014 2:30 pm | News | Comments

A repurposed drug originally used to treat ovarian cancer saw positive results for patients with advanced peritoneal cancers during a phase 1 clinical trial at The University of Kansas Cancer Center, during which it was administered as a bolus injection directly into the peritoneum through a catheter. Read more...

Novimmune to Start Proof of Concept Study for RA Drug

August 5, 2014 11:02 am | News | Comments

Novimmune SA announced the completion of a comprehensive Phase 1 clinical trial investigating the pharmacokinetics, pharmacodynamics, preliminary tolerability and safety of NI-0101, a first-in-class monoclonal antibody against toll-like receptor 4, in presence and absence in vivo of a TLR4 ligand. Read more...

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