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Daily news and top headlines for drug research professionals

Antisense Acromegaly Drug Shows Efficacy in Phase 2

September 5, 2014 11:04 am | News | Comments

Antisense Therapeutics Ltd. reported the primary efficacy results from its Phase 2 clinical trial of ATL1103 in patients with the potentially life threatening growth disorder, acromegaly. Read more...               

Mallinckrodt's Pain Drug Shows Efficacy in Phase 3

September 4, 2014 2:52 pm | News | Comments

Mallinckrodt reported that a Phase 3 efficacy trial of investigational MNK-155 met the study’s primary endpoint of improved pain scores vs. placebo over the first 48 hours following bunionectomy. Read more...            

J&J to Accelerate Ebola Vaccine Development

September 4, 2014 2:40 pm | News | Comments

J&J announced it will fast-track the development of a promising new combination vaccine regimen against Ebola and broadly collaborate with its partners in global health to deliver immediate relief aid to address the current Ebola outbreak. Read more...

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Lilly's Insulin Fares Well in Late-Stage Tests

September 4, 2014 11:31 am | News | Comments

Eli Lilly and Co. plans to seek approval early next year for a new insulin it developed after the diabetes treatment fared better than the competition in two late-stage clinical studies. Read more...               

Exelixis to Cut 70% of Staff After Disappointing Trial Results

September 3, 2014 3:02 pm | News | Comments

Exelixis Inc. announced that COMET-1, the Phase 3 pivotal trial of cabozantinib in men with metastatic castration-resistant prostate cancer, did not meet its primary endpoint. As a result, Exelixis will initiate a significant workforce reduction. Read more...

Alkermes Wraps Enrollment for Phase 2 Antipsychotic Drug Trial

September 3, 2014 11:19 am | News | Comments

Alkermes plc announced completion of patient enrollment in a Phase 2 study of ALKS 3831, an investigational, novel, oral, broad-spectrum atypical antipsychotic medicine in development for the treatment of schizophrenia. Read more...      

ZMapp: Best Anti-Ebola Drug Yet

September 3, 2014 10:15 am | by Cynthia Fox, Science Editor | Articles | Comments

ZMapp, the experimental drug that may have already have saved a few patients in Africa, is the most effective anti-Ebola therapy yet, according to a recent Nature paper on rhesus macaques monkeys. Read more...           

AstraZeneca Releases Phase 4 Brilinta Data

September 2, 2014 3:35 pm | News | Comments

AstraZeneca announced the results of the Phase 4 ATLANTIC study, which indicates that the profile of Brilinta/Brilique (ticagrelor) is comparable whether administered in a pre-hospital or in-hospital setting to ST segment elevation myocardial infarction (STEMI) patients. Read more...

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Bayer Extends Xarelto Investigation to 275,000 Patients

September 2, 2014 10:24 am | News | Comments

Bayer HealthCare and its development partner Janssen Research & Development LLC announced an expansion of the global clinical development program for the oral Factor Xa inhibitor rivaroxaban for the prevention of potentially deadly blood clots in patients at risk of arterial thromboembolism. Read more...

Heart Failure Drug Cuts Deaths, Hospitalizations by 20%

September 2, 2014 9:44 am | News | Comments

A new study reports one of the biggest potential advances against heart failure in more than a decade— a first-of-a-kind, experimental drug that lowered the chances of death or hospitalization by about 20%. Read more...          

FDA Fast Tracks Pfizer's C.diff Vaccine

August 29, 2014 2:00 pm | News | Comments

Pfizer Inc. has announced  that the FDA has granted Fast Track designation to the company’s investigational Clostridium difficile vaccine candidate (PF-06425090). Read more...                 

Amgen Submits BLA for Cholesterol-Lowering Pill

August 29, 2014 2:00 pm | News | Comments

Amgen has announced the submission of a Biologics License Application (BLA) to the FDA for evolocumab seeking approval for the treatment of high cholesterol. Read more...                       

Amgen's Cholesterol-Lowering Drug Meets Co-Primary Endpoints

August 29, 2014 8:30 am | News | Comments

Amgen announced that the Phase 3 YUKAWA-2 study evaluating evolocumab in combination with statin therapy in Japanese patients with high cardiovascular risk and high cholesterol met its co-primary endpoints. Read more...       

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Researchers Investigating New MS Treatment

August 28, 2014 2:00 pm | News | Comments

A new treatment under investigation for multiple sclerosis (MS) is safe and tolerable in Phase 1 clinical trials, according to a new study. The Phase 1 studies were the first to test the drug candidate in humans. Read more...     

GSK-NIH Ebola Vaccine to Enter Safety Testing

August 28, 2014 2:00 pm | by Seth Borenstein, AP Science Writer | News | Comments

Federal researchers next week will start testing humans with an experimental vaccine to prevent the deadly Ebola virus. The NIH announced today that it is launching the safety trial on a vaccine developed by the agency's National Institute of Allergy and Infectious Diseases and GSK. Read more...

FDA Clears Asterias to Begin Stem Cell Trial

August 27, 2014 3:08 pm | News | Comments

Asterias Biotherapeutics Inc. has received clearance from the FDA to initiate a Phase 1/2a clinical trial of its product, AST-OPC1, in patients with complete cervical spinal cord injury. Read more...               

A ‘Second Revolution’ in Drug Discovery and Development

August 27, 2014 9:58 am | by Seth Lederman, M.D., CEO, Tonix Pharmaceuticals | Articles | Comments

Drugs can be discovered and developed in two very different ways: at an evolutionary pace and at a revolutionary pace. The “first revolution” in biological psychiatry took place in the 1950s, and now, in the 21st century, a “second revolution” of drug development and discovery is taking place, driven by repurposing. Read more...

Alkermes Launches Phase 1 Pain Treatment Study

August 26, 2014 3:08 pm | News | Comments

Alkermes plc announced the initiation of a Phase 1 clinical study of ALKS 7106, a proprietary, novel, oral, small-molecule drug candidate for the treatment of pain. Read more...                       

Kite Pharma's Lymphoma Drug Excels in Trial

August 26, 2014 3:03 pm | News | Comments

Shares of Kite Pharma surged before markets opened Tuesday after the drug developer detailed promising results for its most advanced product, a potential treatment for an aggressive form of non-Hodgkin's lymphoma. Read more...       

Pfizer, Merck to Explore Novel Anti-Cancer Combo

August 26, 2014 2:55 pm | News | Comments

Pfizer Inc. and Merck & Co. Inc. announced that they have entered into an agreement to explore the therapeutic potential of the combination of Pfizer’s crizotinib with Merck’s investigational anti-PD-1 antibody pembrolizumab. Read more...   

Avanir Launches Phase 2 MDD Drug Study

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

Avanir Pharmaceuticals Inc. announced the enrollment of the first patient into a Phase 2 study to evaluate the efficacy, safety and tolerability of AVP-786 for the adjunctive treatment of major depressive disorder (MDD). Read more...     

U.S. Army Funds PTSD Treatment Trial

August 25, 2014 3:16 pm | News | Comments

NeuroSigma Inc. announced that the U.S. Department of the Army has funded a Phase 2 clinical trial at UCLA that will examine the use of external trigeminal nerve stimulation (eTNS) as treatment for PTSD. Read more...          

Regado Biosciences Permanently Halts Phase 3 Trial

August 25, 2014 3:08 pm | News | Comments

Regado Biosciences Inc. announced the permanent termination of enrollment in its REGULATE-PCI Phase 3 trial for its lead program, Revolixys Kit. Read more...                           

Baxter's Hemophilia Drug Hits Phase 3 Endpoint

August 22, 2014 4:05 pm | News | Comments

Baxter International Inc. announced positive results from its Phase 3 pivotal clinical trial of BAX 855, an investigational, extended half-life recombinant factor VIII (rFVIII) treatment for hemophilia A. Read more...          

OncoGenex Says Lung Cancer Drug Trial Will Continue

August 22, 2014 11:01 am | News | Comments

OncoGenex Pharmaceuticals announced that the Phase 3 ENSPIRIT trial, evaluating custirsen in the treatment of non-small cell lung cancer, is continuing as planned per the recommendation of the Independent Data Monitoring Committee based upon completion of the first interim futility analysis. Read more...

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