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Daily news and top headlines for drug research professionals

Relmada Files Clinical Trial App for D-Methadone in Canada

September 11, 2014 10:40 am | News | Comments

Relmada Therapeutics Inc. announced that it has filed a Clinical Trial Application (CTA) with Heath Canada to conduct two pharmacokinetic studies with d-methadone. Read more...                      

Antibiotics Do Not Shorten TB Treatment, Trial Finds

September 10, 2014 10:45 am | News | Comments

The results of a Phase 3 clinical trial, called REMoxTB, has found that replacing one of the drugs with the antibiotic moxifloxacin in the standard six-month treatment regimen did not allow the treatment time for TB patients to be shortened to four months. Read more...

Galena Begins Phase 2 GALE-401 Trial

September 9, 2014 3:04 pm | News | Comments

Galena Biopharma Inc. announced the first patient has been dosed in the GALE-401, or Anagrelide Controlled Release (CR), Phase 2 clinical trial, which will treat patients with elevated platelet counts in myeloproliferative neoplasms (MPNs). Read more...

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Pharmatech, Weill Cornell Medical College Form Oncology Collaboration

September 9, 2014 2:58 pm | News | Comments

Pharmatech, Weill Cornell Medical College (WCMC) and 25 other leading oncology practices have agreed to evaluate an innovative program for rapidly identifying and enrolling patients in oncology clinical trials. Read more...        

NIAAA Conducting Trial of New Medication for Alcohol Use Disorder

September 9, 2014 2:46 pm | News | Comments

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) will conduct a clinical trial of gabapentin enacarbil as a potential treatment for alcohol use disorder (AUD). NIAAA estimates that the six-month trial will begin in the first half of 2015 and will enroll approximately 350 participants. Read more...    

BI COPD Combo Excels in Phase 3

September 9, 2014 11:27 am | News | Comments

Boehringer Ingelheim presented the first data from the pivotal Phase 3 TONADO 1&2 studies (NCT01431274/NCT01431287) for the fixed-dose combination (FDC) of tiotropium plus olodaterol delivered via the Respimat inhaler in patients with moderate to very severe chronic obstructive pulmonary disease. Read more...

GSK Asthma Drug Hits Primary Endpoints in Two Key Trials

September 9, 2014 11:08 am | News | Comments

Results published in the New England Journal of Medicine (NEJM) and presented at the European Respiratory Society (ERS) congress provide further data from MENSA and SIRIUS, the two pivotal Phase 3 asthma studies of mepolizumab, an investigational IL-5 antagonist monoclonal antibody. Read more...

Novartis Ultibro Breezhaler Superior in Reducing COPD Flare Ups

September 9, 2014 10:54 am | News | Comments

Novartis presented new data that demonstrated once-daily Ultibro Breezhaler was superior in reducing exacerbations and improving lung function compared to twice-daily Seretide Accuhaler, in patients with moderate-to-severe chronic obstructive pulmonary disease. Read more...

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Mast's AIR001 Promising in Phase 2

September 8, 2014 3:16 pm | News | Comments

Mast Therapeutics Inc. reported top-line results from a Phase 2 study of AIR001 (sodium nitrite) inhalation solution for the treatment of pulmonary arterial hypertension (PAH). Read more...                 

Gilead, GSK Combo Drug Promising as PAH Treatment

September 8, 2014 3:14 pm | News | Comments

Gilead Sciences Inc. announced results from the AMBITION study, which was conducted in collaboration with GlaxoSmithKline (GSK). Read more...                                

Mayo Clinic, IBM Task Watson to Improve Clinical Trials

September 8, 2014 2:50 pm | News | Comments

Mayo Clinic and IBM announced plans to pilot Watson, the IBM cognitive computer, to match patients more quickly with appropriate clinical trials, beginning with research studies in cancer. Read more...              

AZ's COPD Drug Gets Mixed Results in Phase 2a

September 8, 2014 11:11 am | News | Comments

AstraZeneca announced that a Phase 2a study evaluating its novel investigational monoclonal antibody benralizumab in patients with COPD did not meet the primary endpoint, but that benralizumab demonstrated clinically significant improvements in lung function in the overall population. Read more...

Single-Dose Flu Drug Shows Promise in Trials

September 8, 2014 10:54 am | News | Comments

BioCryst Pharmaceuticals Inc. announced trial results related to Rapivab (peramivir injection), a neuraminidase inhibitor (NAI) for the treatment of influenza, at the ICAAC. Read more...                   

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FDA Lifts Partial Hold on OncoMed's Cancer Drug

September 5, 2014 2:52 pm | News | Comments

OncoMed Pharmaceuticals announced that the FDA removed the partial clinical hold on the company's ipafricept (FZD8-Fc, OMP-54F28) Phase 1 clinical trials. Read more...                        

NeuroDerm Starts Phase 2a Study of Parkinson’s Drug

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

NeuroDerm Ltd. announced that the first patients with severe Parkinson’s disease have been enrolled and dosed in a Phase 2a trial of ND0612H, a high-dose form of NeuroDerm’s proprietary liquid levodopa/carbidopa (LD/CD) drug formulation. Read more...

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...

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...

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...          

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