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Daily news and top headlines for drug research professionals

Mylan to Begin Phase 3 Trials on Key Generics

September 16, 2014 3:28 pm | News | Comments

Mylan Inc. announced it is initiating Phase 3 clinical trials for its generic version of GlaxoSmithKline's Advair Diskus and its insulin analog to Sanofi's Lantus.  Read more...                   

Bayer, Orion Initiate Phase 3 Prostate Cancer Trial

September 16, 2014 10:26 am | News | Comments

Bayer HealthCare and Orion Corp. have begun to enroll patients in a Phase 3 trial with ODM-201, an investigational novel oral androgen receptor (AR) inhibitor in clinical development for the treatment of patients with prostate cancer. Read more...

Novo Nordisk's Insulin Shows Long-Term Efficacy in Children, Adolescents

September 16, 2014 10:19 am | News | Comments

Novo Nordisk announced new data from the BEGIN YOUNG 1 trial investigating once-daily Tresiba (insulin degludec) versus insulin detemir, both in combination with bolus insulin aspart in a 52-week trial in children and adolescents with type 1 diabetes. Read more...

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Merck Osteoporosis Drug Meets Primary Endpoint in Phase 3

September 15, 2014 3:49 pm | News | Comments

Merck announced data from the pivotal Phase 3 fracture outcomes study for odanacatib in postmenopausal women with osteoporosis. Odanacatib is Merck’s investigational once-weekly cathepsin K inhibitor. Read more...           

Lilly Colorectal Cancer Drug Hits OS Endpoint

September 15, 2014 3:31 pm | News | Comments

Eli Lilly and Co. announced that the RAISE trial, a Phase 3 study of ramucirumab (Cyramza) in combination with chemotherapy in patients with metastatic colorectal cancer (mCRC), met its primary endpoint of overall survival. Read more...     

Amgen Heart Study Shows Positive Ivabradine Results

September 15, 2014 3:18 pm | News | Comments

Amgen announced data from the Phase 3 SHIFT study evaluating ivabradine in patients with chronic heart failure (HF) were presented at the 18th Annual Scientific Meeting of the Heart Failure Society of America (HFSA) in Las Vegas. Read more...   

Avanir Drug for Alzheimer's Agitation Excels in Trial

September 15, 2014 3:07 pm | News | Comments

Shares of Avanir Pharmaceuticals soared Monday after the company reported positive clinical trial results for a drug that is designed to treat agitation in Alzheimer's disease patients. Read more...                

Cardio3 BioSciences to Continue Phase 3 Heart Therapy Trial

September 15, 2014 10:53 am | News | Comments

Cardio3 BioSciences SA (C3BS) announced it has received the recommendation of the Data Safety and Monitoring Board (DSMB) to continue the CHART-1 clinical trial according to the original protocol. Read more...            

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Biogen's Phase 3 Tecfidera Trial Shows Positive 5-Year MS Data

September 11, 2014 2:57 pm | News | Comments

Biogen Idec announced that five-year results from the ENDORSE Phase 3 extension study show Tecfidera (dimethyl fumarate) provides strong and sustained efficacy in a broad range of people living with relapsing-remitting multiple sclerosis (RRMS). Read more...

Two Anti-Ebola Vaccines in Historic Race

September 11, 2014 2:41 pm | by Cynthia Fox, Science Editor | Articles | Comments

One of the most rapidly fast-tracked vaccines in history— an anti-Ebola “ChAd3” vaccine— just started clinical trial in humans, and may be done as soon as November. But a second fast-tracked anti-Ebola vaccine— called an “rVSV” vaccine— is hot on its heels. Read more...

Sanofi Posts Promising Trial Results for MS Drug

September 11, 2014 11:02 am | News | Comments

Sanofi and its subsidiary Genzyme announced positive interim results from the second year of the extension study of Lemtrada (alemtuzumab) for multiple sclerosis. Read more...                      

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...

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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...

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...

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...                   

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...                        

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