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Daily news and top headlines for drug research professionals

EMD Serono Announces 2014 GMSI Grant Winners

September 15, 2014 11:29 am | News | Comments

EMD Serono announced the recipients of the second annual Grant for Multiple Sclerosis Innovation at the 2014 Joint ACTRIMS-ECTRIMS Meeting of the Americas Committee for Treatment and Research in MS (ACTRIMS) and European Committee for Treatment and Research in MS (ECTRIMS). Read more...

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...   

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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...                 

Novartis, Penn Team for Cellular Therapeutics Center

September 12, 2014 2:00 pm | News | Comments

The Univ. of Pennsylvania has reached an important milestone in its alliance with Novartis as it unveiled plans for the construction of a first-of-its-kind Center for Advanced Cellular Therapeutics on the Penn Medicine campus in Philadelphia.

Scientists Can Reset Human Stem Cells

September 12, 2014 2:00 pm | News | Comments

Scientists have successfully reset human pluripotent stem cells to the earliest developmental state– equivalent to cells found in an embryo before it implants in the womb (seven to nine days old). These pristine stem cells may mark the true starting point for human development, but have until now been impossible to replicate in the lab.

BioTime, Charity Partner for Trial of Vaccine for Lung Cancer

September 12, 2014 2:00 pm | News | Comments

BioTime, Inc. announced that its subsidiary Asterias Biotherapeutics, Inc. has reached an agreement with Cancer Research UK and Cancer Research Technology— the charity’s development and commercialization arm— to conduct a clinical trial of Asterias’ novel immunotherapy treatment AST-VAC2 in subjects with non-small cell lung cancer.

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FDA Backs Injection for Obesity

September 12, 2014 2:00 pm | News | Comments

Federal health experts say Novo Nordisk's diabetes drug Victoza should be approved for a new use in treating obesity. The panel of Food and Drug Administration advisers voted 14-1 that the injectable drug's benefits outweigh its risks for patients who are obese or dangerously overweight.

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...                         

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...

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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...                      

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...

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...

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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