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Daily news and top headlines for drug research professionals

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...

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...            

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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...

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...

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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...

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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...                     

J&J, Janssen Partner with University of Toronto on Brain Treatments

September 8, 2014 11:16 am | News | Comments

The University of Toronto announced a new strategic open innovation collaboration with Janssen Inc. facilitated by the Johnson & Johnson Innovation center of California that will support research through the Collaborative Center for Drug Research (CCDR). 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...                   

EU Approves Roche's RoACTEMRA for RA

September 8, 2014 10:43 am | News | Comments

Roche announced that RoACTEMRA (tocilizumab) has received approval from the European Commission for use in patients with severe, active and progressive RA. Read more...                       

Ascendia Advances Nano-Emulsion Technology Platform with ASD-002 Program

September 5, 2014 3:06 pm | News | Comments

Ascendia Pharmaceuticals announced that the company has successfully applied its nano-emulsion technology platform to a novel injectable formulation of clopidogrel- the world’s top-selling blood thinner medicine. Read more...       

Soligenix Acquires Phase-3-Ready Oncology Program

September 5, 2014 2:58 pm | News | Comments

Soligenix Inc. announced the acquisition of a novel orphan drug candidate, known as SGX301, which is poised to enter pivotal Phase 3 clinical testing for the treatment of cutaneous T-cell lymphoma and is highly synergistic with the company’s existing development pipeline. Read more...

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