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Daily news and top headlines for drug research professionals

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...                           

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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...

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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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Gamida Cell, Novartis Sign Option Agreement

August 19, 2014 11:56 am | News | Comments

Gamida Cell, a world leader in stem cell expansion technologies and therapeutic products, announced that it has signed an investment and option agreement with Novartis Pharma AG, under which Novartis will invest $35 million in Gamida Cell. Read more...

DelMar Pharmaceuticals Amends Glioblastoma Trial

August 19, 2014 11:49 am | News | Comments

DelMar Pharmaceuticals Inc. announced a protocol amendment to allow for expanded dosing in its VAL-083 clinical trial had been filed with the U.S. Food and Drug Administration and that a new cohort of a new 50mg/m2 has been opened at three clinical trial sites in the United States. Read more...

FDA Tentatively Approves Lilly, BI Insulin Glargine

August 19, 2014 11:37 am | News | Comments

The U.S. Food and Drug Administration granted tentative approval for Basaglar (insulin glargine injection), which is indicated to improve glycemic control in adults with type 2 diabetes and in combination with mealtime insulin in adults and pediatric patients with type 1 diabetes. Read more...

AstraZeneca Posts Positive Antibiotic Combo Results

August 19, 2014 11:30 am | News | Comments

AstraZeneca announced positive top-line results from RECLAIM-1 and RECLAIM-2, the pivotal Phase 3 studies investigating the potential of the antibiotic ceftazidime-avibactam as a treatment for hospitalized adult patients with complicated intra-abdominal infections. Read more...

Ruxolitinib Restores Hair in Alopecia Areata

August 18, 2014 2:28 pm | News | Comments

Researchers have identified the immune cells responsible for destroying hair follicles in people with alopecia areata, a common autoimmune disease that causes hair loss, and have tested an FDA-approved drug that eliminated these immune cells and restored hair growth in a small number of patients. Read more...

Daiichi Sankyo Kicks Off Etanercept Biosimilar Trial

August 18, 2014 11:11 am | News | Comments

Daiichi Sankyo Co. Ltd., in collaboration with the U.S. company Coherus BioSciences Inc., announced the start of the Phase 3 trial of CHS-0214, an investigational etanercept biosimilar, in rheumatoid arthritis (the RApsody trial) in Japan. Read more...

Pfizer Submits NDA for Breast Cancer Drug

August 18, 2014 11:04 am | News | Comments

Pfizer Inc. announced it has completed the submission of a New Drug Application to the U.S. Food and Drug Administration for palbociclib in combination with letrozole for the treatment of postmenopausal women with ER+/HER2- breast cancer who have not received previous systemic treatment for advanced disease. Read more...

Coherus' Humira Biosimilar Hits Primary Endpoint

August 15, 2014 2:28 pm | News | Comments

Coherus BioSciences Inc. announced that CHS-1420, its proposed biosimilar of adalimumab (Humira), met the primary endpoint in a pivotal clinical pharmacokinetic similarity study that compared CHS-1420 to Humira in healthy subjects. Read more...   

Isis Earns $2M from the Advancement of SMA Drug

August 15, 2014 2:07 pm | News | Comments

Isis Pharmaceuticals Inc. announced that it has earned a $2 million milestone payment from Biogen Idec related to the advancement of the ongoing open-label extension study of ISIS-SMNRx in children with spinal muscular atrophy. Read more...    

FDA Accepts BLA for Meningococcal Vaccine

August 15, 2014 10:18 am | News | Comments

Pfizer Inc. announced that the U.S. Food and Drug Administration has accepted for review the Biologics License Application for bivalent recombinant LP2086, the company’s vaccine candidate for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in 10 through 25 year olds. Read more...

FDA Approves Avastin in Cervical Cancer

August 15, 2014 10:00 am | News | Comments

Roche announced that the U.S. Food and Drug Administration (FDA) approved Avastin (bevacizumab) in combination with paclitaxel and cisplatin or paclitaxel and topotecan for the treatment of women with persistent, recurrent or metastatic carcinoma of the cervix. Read more...

Chikungunya Vaccine Induces Robust Antibody Response

August 15, 2014 9:55 am | News | Comments

An experimental vaccine to prevent the mosquito-borne viral illness chikungunya elicited neutralizing antibodies in all 25 adult volunteers who participated in a recent early-stage clinical trial conducted by researchers at the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. Read more...

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