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Daily news and top headlines for drug research professionals

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...

FDA Approves New Indication for the Use of Xtandi

September 11, 2014 2:51 pm | News | Comments

Astellas Pharma and Medivation announced that FDA approved a new indication for the use of Xtandi (enzalutamide) capsules to treat patients with metastatic castration-resistant prostate cancer (CRPC). Read more...           

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...                         

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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...                      

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…

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Drug Safety Report Details 49,000 Undisclosed Side Effect Reports

September 10, 2014 1:45 pm | News | Comments

Healthcare informatics company AdverseEvents Inc. released a special drug safety report that includes an analysis of 48,971 unreleased FAERS reports. 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...

Nutrient Combo May be 'Super Pill' to Treat Depression

September 10, 2014 10:41 am | News | Comments

A new study will help people suffering from clinical depression by offering them new combination of nutrient-based medications to enhance mood. 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...   

Sleep, Anxiety Meds May Increase Alzheimer's Risk

September 10, 2014 10:23 am | News | Comments

Taking benzodiazepines (widely prescribed drugs to treat anxiety and insomnia) is associated with an increased risk of developing Alzheimer's disease, particularly for long-term users, suggests a new study. Read more...         

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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...

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...

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...

Researchers ID New Genetic Target for a Different Kind of Cancer Drug

September 9, 2014 11:13 am | News | Comments

Researchers have discovered that the protein RBM4, a molecule crucial to the process of gene splicing, is drastically decreased in multiple forms of human cancer, including lung and breast cancers. 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...                                

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...               

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...

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