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DDD Update

Daily news and top headlines for drug research professionals

FDA Accepts Shire's sNDA for Vyvanse

September 15, 2014 3:43 pm | News | Comments

Shire announced that the FDA has accepted for filing with priority review a supplemental New Drug Application for Vyvanse (lisdexamfetamine dimesylate) capsules as a treatment for adults with binge eating disorder (BED). Read more...     

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FDA Committee Backs Approval of Natpara for Treatment of Hypoparathyroidism

September 15, 2014 3:37 pm | News | Comments

NPS Pharmaceuticals Inc. announced that the FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted that the available data support the approval of Natpara for the long-term treatment of hypoparathyroidism. Read more...      

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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...     

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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...   

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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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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...

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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...

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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...            

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NIH Awards Aim to Improve Understanding of Cell Pathways

September 15, 2014 10:33 am | News | Comments

Building on a successful three-year pilot project, the National Institutes of Health has awarded more than $64 million to six research institutions to create a database of human cellular responses. Discovering such cell responses will improve scientists’ understanding of cell pathways and aid in the development of new therapies. Read more...

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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...                 

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Researchers Find Defense Mechanism Against Viruses

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

Researchers have discovered that a known quality control mechanism in human, animal and plant cells is active against viruses. They think it might represent one of the oldest defense mechanisms against viruses in evolutionary history.

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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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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.

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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.

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