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Daily news and top headlines for drug research professionals

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...          

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...                       

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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'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...       

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...               

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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...     

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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...

EMA Accepts Ceftolozane/Tazobactam MAA for Review

August 22, 2014 10:54 am | News | Comments

Cubist Pharmaceuticals announced that the European Medicines Agency has accepted for review the company’s Marketing Authorization Application for its investigational antibiotic ceftolozane/tazobactam for the treatment of complicated urinary tract Infections and complicated intra-abdominal infections. Read more...

Bioethicists Say Ebola Drugs Must be Fairly Distributed, Tested Ethically

August 22, 2014 10:42 am | News | Comments

Researchers and health authorities need to ensure that experimental drugs to treat Ebola are distributed fairly, and in the context of randomized controlled trials in collaboration with local communities and other stakeholders, according to a new Viewpoint, published in The Lancet. Read more...

Eisai Submits EU Marketing Authorization for Anti-Epileptic

August 21, 2014 11:34 am | News | Comments

Eisai has submitted a Marketing Authorization Application to the European Commission for its first-in-class anti-epileptic drug (AED) Fycompa (perampanel) as an adjunctive treatment of primary generalized tonic-clonic seizures (PGTC). Read more...

Psoriasis Drug Fares Well in Late-Stage Trial

August 21, 2014 11:25 am | News | Comments

Drugmaker Eli Lilly and Co. said its potential psoriasis treatment fared better than both a fake drug and a competitor's product during late-stage testing on patients with the most common form of the skin disease and plans to submit the product, ixekizumab, to regulators in the first half of next year. Read more...

CEL-SCI Expands Head, Neck Cancer Trial in North America

August 20, 2014 10:47 am | News | Comments

CEL-SCI Corporation announced its Phase 3 Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine has added Centre Hospitalier Universitaire de Québec’s L’Hotel Dieu de Quebec to its growing number of clinical sites in North America. Read more...

NIH Launches Three Integrated Precision Medicine Trials

August 19, 2014 4:01 pm | News | Comments

The NIH's Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials (ALCHEMIST) was launched Monday to identify early-stage lung cancer patients with tumors that harbor certain uncommon genetic changes and evaluate whether drug treatments targeted against those changes can lead to improved survival. Read more...

Amgen's Thyroid Drug Hits Key Phase 3 Endpoints

August 19, 2014 3:52 pm | News | Comments

Amgen announced that a second placebo-controlled Phase 3 study evaluating AMG 416 for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD), receiving hemodialysis, met its primary and all secondary endpoints. Read more...

DOJ Closes Probe into AstraZeneca Trial

August 19, 2014 3:26 pm | News | Comments

British drugmaker AstraZeneca says the U.S. Department of Justice has closed its investigation into a clinical trial of the company's blood thinner Brilinta, and plans no further action. Read more...               

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