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Daily news and top headlines for drug research professionals

Amgen Cholesterol Drug Meets Endpoints in Phase 3

January 29, 2014 2:14 pm | News | Comments

Amgen announced that the Phase 3 LAPLACE-2 trial evaluating evolocumab in combination with statin therapy in patients with high cholesterol met its co-primary endpoints. So what were the primary endpoints? Find out...         

Astellas, Medivation Reveal Trial Results for Enzalutamide in Prostate Cancer

January 29, 2014 10:42 am | News | Comments

Medivation Inc. and Astellas Pharma Inc. announced final results on the primary and secondary efficacy endpoints from the Phase 3 PREVAIL trial of enzalutamide in patients with chemotherapy-naïve metastatic prostate cancer. Read more...

Cancer Research UK Launches New Lymphoma Trial

January 29, 2014 10:22 am | News | Comments

Cancer Research UK’s Drug Development Office (DDO) has launched a new clinical trial to treat lymphoma patients using the body’s own immune system to attack cancerous B-cells growing out of control. Read more...            

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TherapeuticsMD Posts Positive Menopause Study Results

January 28, 2014 2:42 pm | News | Comments

Shares of TherapeuticsMD rose after the company reported positive study results for a drug designed to treat symptoms of menopause. The company said women who took its drug, called Vagicap, had lower levels of the hormone estradiol in their bodies than those who took the drug Vagifem. Read more...

TherapeuticsMD Posts Positive Menopause Study Results

January 28, 2014 2:42 pm | News | Comments

Shares of TherapeuticsMD rose after the company reported positive study results for a drug designed to treat symptoms of menopause. The company said women who took its drug, called Vagicap, had lower levels of the hormone estradiol in their bodies than those who took the drug Vagifem. Read more...

Oramed to Present Trial Results for Oral Insulin

January 28, 2014 11:07 am | News | Comments

Oramed Pharmaceuticals Inc. announced that it will announce the results of its Phase 2a clinical trial for the company's ORMD-0801 oral insulin capsule for the treatment of type 2 diabetes. Read more...              

Potential MRSA Treatment Trial Launched

January 27, 2014 2:53 pm | News | Comments

Scientists have begun the first human clinical trial of EDP-788, an investigational oral antibiotic intended to treat MRSA infections. So what are the details of the trial? Find out...                   

Celsion Plans New Liver Cancer Drug Trial

January 27, 2014 1:52 pm | News | Comments

Celsion said Monday it wants to start another late-stage clinical trial of its liver cancer drug ThermoDox. But what has changed from a year ago, when the drug did not meet its main goal in a clinical trial? Read more...       

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Pfizer Cancer Drug Fails in Late-Stage Trials

January 27, 2014 9:08 am | News | Comments

A potential Pfizer Inc. treatment for an advanced form of lung cancer missed its main goals in two late-stage studies, but the drugmaker said it is still waiting for results from a third study. So what were the goals that dacomitinib missed? Find out...

GSK Drug Combo Ups Melanoma Survival

January 24, 2014 2:51 pm | News | Comments

GlaxoSmithKline announced that a Phase 3 study of the combination of Tafinlar and Mekinist, compared to single agent therapy with Tafinlar, met its primary endpoint of Progression Free Survival in patients metastatic melanoma. Read more...    

CHMP Grants Positive Opinion for Novartis Skin Treatment

January 24, 2014 2:37 pm | News | Comments

Novartis announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for the use of Xolair (omalizumab) as an add-on therapy for the treatment of chronic spontaneous urticaria. Read more...

BioDelivery Sciences Reveals Early Pain Treatment Results

January 24, 2014 8:09 am | News | Comments

Shares of BioDelivery Sciences jumped Friday after the drug developer said its experimental pain treatment outperformed a placebo in late-stage testing. So what does this mean for the company's partnership with Endo Health Solutions? Read more...

Plant Sterol/Stanol Softgels Effectively Lower Cholesterol

January 23, 2014 2:52 pm | News | Comments

A new research study demonstrated the effectiveness of a sterol/stanol ester softgel capsule for lowering low-density lipoprotein (LDL) cholesterol in individuals with high cholesterol levels. Read more...               

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Amgen's Cholesterol Drug Meets Primary Endpoints

January 23, 2014 2:05 pm | News | Comments

Amgen announced that the Phase 3 GAUSS-2 trial evaluating evolocumab in patients with high cholesterol who cannot tolerate statins met its co-primary endpoints. What were the major milestones achieved in the trial? Find out...        

Amgen's Cholesterol Drug Meets Primary Endpoints

January 23, 2014 2:05 pm | News | Comments

Amgen announced that the Phase 3 GAUSS-2 trial evaluating evolocumab in patients with high cholesterol who cannot tolerate statins met its co-primary endpoints. What were the major milestones achieved in the trial? Find out...        

Prosonix COPD Drug Excels in Phase 2 Trial

January 23, 2014 10:35 am | News | Comments

Prosonix announced positive top-line results from its Phase 2 clinical study with PSX1002 in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Read more...                   

Drug Combo 'Melts Away' Leukemia

January 23, 2014 10:26 am | News | Comments

Use of a twice-daily pill could turn a deadly blood cancer into a highly treatable disease, according to scientists. So what combination of drugs did the researchers use? Find out...                    

EnVivo Initiates Phase 3 Alzheimer’s Trial

January 22, 2014 1:02 pm | News | Comments

EnVivo Pharmaceuticals announced it has initiated COGNITIV AD, a Phase 3 clinical program evaluating its novel alpha-7 potentiator, encenicline-hydrochloride (EVP-6124), in patients with Alzheimer’s disease (AD). Read more...        

All FDA Drug Approvals Not Created Equal

January 22, 2014 12:26 pm | News | Comments

The safety and effectiveness of newly approved drugs is assumed to be well understood by the FDA— but a new study shows that the clinical trials used by the FDA to approve new drugs between 2005 and 2012 vary widely in their thoroughness. Read more...

Takeda Launches Phase 3 Cancer Trial in Asia

January 22, 2014 10:36 am | News | Comments

Takeda Development Center Shanghai and Takeda Development Center Asia announced that the TOURMALINE-MM1 global Phase 3 study has commenced in Asia for Takeda's oral proteasome inhibitor, ixazomib, in relapsed and/or refractory multiple myeloma (MM). Read more...

KV Pharma's Makena Study Becomes Largest of its Kind

January 21, 2014 11:45 am | News | Comments

K-V Pharmaceutical Co. announced it has enrolled 677 women in its ongoing international Phase 3B safety and efficacy trial of Makena, the only FDA-approved medication indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. Read more...

Stem Cell Discovery Leads to Trial for Heart Failure Patients

January 21, 2014 10:55 am | Videos | Comments

Cardio3 BioSciences, an international Mayo Clinic collaborator, has received FDA approval for a Phase 3 pivotal clinical trial of its stem cell therapy. Watch the video to see how stem cells are being used to treat people with heart failure.   

Pluristem Reveals Top-Line Results from Muscle Injury Trial

January 21, 2014 10:48 am | News | Comments

Pluristem Therapeutics Inc. announced top-line results from its Phase 1/2 clinical trial of PLacental eXpanded (PLX-PAD) cells in the treatment of muscle injury. Did the treatment successfully meet primary safety and efficacy endpoints? Read more...

Abraxane Extends OS for Pancreatic Cancer in Phase 3

January 20, 2014 11:02 am | News | Comments

Breast cancer drug Abraxane (nanoparticle albumin-bound paclitaxel) has been shown to extend overall survival (OS) for patients with metastatic pancreatic cancer when used in combination with current standard of care, gemcitabine, with some patients surviving longer than three years. Read more...

Compounds in Chocolate, Tea, Berries Could Guard Against Diabetes

January 20, 2014 10:28 am | News | Comments

Eating high levels of flavonoids, including anthocyanins and other compounds found in berries, tea and chocolate, could offer protection from type 2 diabetes. But how do these ingredients impact insulin resistance and better blood glucose regulation? Find out...

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