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Daily news and top headlines for drug research professionals

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...                

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Akashi Acquires Global Rights to Novel DMD Treatment

September 15, 2014 11:16 am | News | Comments

Akashi Therapeutics Inc. announced that it has acquired global rights to GsMTx-4, a peptide developed to address calcium level imbalance in muscle, a critical issue in Duchenne muscular dystrophy contributing to loss of function and other associated pathologies. Read more...

Germany's Merck Discontinues Lung Cancer Drug Program

September 15, 2014 11:01 am | News | Comments

Merck Serono will discontinue the clinical development program of its investigational MUC1 antigen-specific cancer immunotherapy tecemotide (also known as L-BLP25) as a monotherapy in Stage III non-small cell lung cancer (NSCLC). 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...            

Gilead to License Generic Version of Sovaldi

September 15, 2014 8:41 am | by The Associated Press | News | Comments

Gilead Sciences has reached a deal with several generic drugmakers to produce cheaper versions of its popular, expensive hepatitis C drug Sovaldi for use in developing countries. Read more...                 

Biogen Shows Positive Effects in Year Two of RMS Drug Trial

September 12, 2014 7:00 am | News | Comments

Biogen Idec announced new data from the second year of its Phase 3 ADVANCE clinical trial that show the positive treatment effects of PLEGRIDY (peginterferon beta-1a) were maintained in people with relapsing forms of multiple sclerosis (RMS) beyond the first year of the study. 

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University Working Toward Long-Acting HIV Drugs

September 12, 2014 7:00 am | News | Comments

HIV drugs that only need to be taken once a month are to be developed at the University of Liverpool in a bid to overcome the problem of "pill fatigue." To help address the problem, scientists are developing injections that provide therapeutic exposure to the drugs for at least a month and may replace daily tablets in some patients.

Phase 2a Begins for Genocea's Pneumococcus Vaccine

September 12, 2014 7:00 am | News | Comments

Genocea Biosciences, Inc. announced the initiation of a Phase 2a trial for GEN-004, the company’s universal vaccine candidate against pneumococcus. The trial is designed to evaluate the effect of dosing with GEN-004 on the frequency, magnitude and duration of colonization by pneumococcus in the nasopharynx of healthy adults.

Data Validate 3x/Week MS Injections

September 12, 2014 7:00 am | News | Comments

Teva Pharmaceutical Industries Ltd. announced new data from the open-label Phase IIIb GLatiramer Acetate low frequenCy safety and patIent ExpeRience (GLACIER) study, comparing the safety and tolerability of three-times-a-week COPAXONE (glatiramer acetate injection) 40 mg to daily COPAXONE 20 mg in patients with relapsing-remitting multiple sclerosis (RRMS). 

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...           

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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...                      

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…

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...         

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...    

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