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Daily news and top headlines for drug research professionals

Many Hospitals Use Too Many Antibiotics, Study Says

September 11, 2014 2:46 pm | by Mike Stobbe, AP Medical Writer | News | Comments

Doctors in many U.S. hospitals are unnecessarily prescribing multiple antibiotics for several days when just one would do the job, a new study suggests. 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...                      

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CRUK, Asterias Biotherapeutics Partner on Lung Cancer Vaccine Trial

September 11, 2014 10:51 am | News | Comments

Cancer Research UK and Cancer Research Technology have reached an agreement with Asterias Biotherapeutics Inc. to take forward Asterias' novel immunotherapy treatment AST-VAC2 into clinical trials in subjects with non-small cell lung cancer. 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...                      

FDA Approves Weight-Loss Drug Contrave

September 11, 2014 9:57 am | News | Comments

U.S. regulators are greenlighting a new weight-loss drug called Contrave, the third in a string of approvals for anti-obesity treatments. The drug was developed by Orexigen Therapeutics Inc., based in La Jolla, California. Read more...      

Mylan to Acquire Arixtra Rights for $225M

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

Mylan Inc. announced that its subsidiary Mylan Ireland Ltd. has entered into an agreement to acquire the U.S. commercialization, marketing and intellectual property rights relating to Arixtra Injection, and the authorized generic, from Aspen Global Inc. Read more…

MabVax Therapeutics, MSK Partner to Develop Anti-Cancer Therapies

September 10, 2014 2:17 pm | News | Comments

MabVax Therapeutics Holdings Inc. announced it has entered into agreements with Memorial Sloan Kettering Cancer Center and Juno Therapeutics for the development of novel therapeutic products using antibody targeting sequences. Read more...

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EMD Serono, Accelerated Cure Project Launch MS Research Program

September 10, 2014 2:09 pm | News | Comments

EMD Serono, Inc. and the Accelerated Cure Project for Multiple Sclerosis announced a lead founding sponsor agreement to help launch the Optimizing Treatment—Understanding Progression (OPT-UP) study. 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...

FDA Committee Votes Against Actavis Hypertension Drug

September 10, 2014 10:31 am | News | Comments

Actavis confirmed that the FDA Cardiovascular and Renal Drugs Advisory Committee has voted to recommend against approval of Actavis' NDA for the fixed-dose combination of nebivolol and valsartan for the treatment of hypertension. Read more...   

EC Grants Marketing Authorization for Lilly-BI Insulin

September 10, 2014 9:28 am | News | Comments

The European Commission (EC) granted marketing authorization for Eli Lilly and Company and Boehringer Ingelheim's insulin glargine product, indicated to treat diabetes in adults, adolescents and children aged two years and above. Read more...    

Auxilium to Cut 30% of Workforce

September 10, 2014 9:00 am | News | Comments

Auxilium Pharmaceuticals said Tuesday it is cutting 30 percent of its workforce, about 190 jobs, as part of a restructuring of its operations that will save it at least $75 million a year. The moves come as the company struggles with sales of its testosterone replacement gel Testim. Read more...

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Kinex Completes Acquisition of QuaDPharma

September 9, 2014 3:09 pm | News | Comments

Kinex Pharmaceuticals Inc. announced that it has completed the acquisition of QuaDPharma LLC, a Western New York based privately-held company specializing in pharmaceutical manufacturing, analytical and support services to the pharmaceutical and biotech industries. 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...

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...              

FTC Sues AbbVie, Teva Over Generic AndroGel

September 8, 2014 2:34 pm | News | Comments

The Federal Trade Commission is suing drugmakers AbbVie and Teva, saying they conspired to temporarily keep generic versions of AbbVie's low-testosterone drug AndroGel off the market. Read more...               

Parkinson's, Cancer Findings Earn Medical Prizes

September 8, 2014 1:30 pm | by Malcolm Ritter, AP Science Writer | News | Comments

Key discoveries about breast cancer, Parkinson's disease and the body's handling of defective proteins have earned prestigious medical awards for five scientists. Read more...                     

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