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DDD Update

Daily news and top headlines for drug research professionals

FDA Approves First Drug-Coated Angioplasty Balloon Catheter for PAD

October 10, 2014 3:23 pm | News | Comments

The U.S. Food and Drug Administration approved the Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB). Read more...                              

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Gilead Sciences' Once-Daily Hepatitis C Drug Approved by FDA

October 10, 2014 3:02 pm | News | Comments

Gilead Sciences, Inc. announced that the U.S. FDA has approved Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg), the first once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults. Read more...

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Researchers Begin Study of Ebola Vaccine in Africa

October 10, 2014 2:06 pm | News | Comments

The first study of a possible Ebola vaccine is underway in Africa: University of Maryland researchers say three health care workers in Mali received the experimental shots. Read more...

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FDA Approves Drug for Nausea, Vomiting Associated With Chemo

October 10, 2014 12:18 pm | News | Comments

The FDA approved Akynzeo (netupitant and palonosetron) to treat nausea and vomiting in patients undergoing cancer chemotherapy. Read more...                                         

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BIT225 Trial Results Show Effective Cure of Hepatitis C

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

Australian drug development company Biotron Ltd. announced that all Hepatitis C virus (HCV) genotype 3 (G3) patients completing a key Phase 2 trial of its lead antiviral drug, BIT225, have undetectable levels of HCV 12 weeks after ceasing all treatment. Read more...

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Janssen Seeks Approval of Psoriasis Drug

October 10, 2014 10:34 am | News | Comments

Janssen-Cilag International NV (Janssen) announced that a Type 2 Variation has been filed with the European Medicines Agency seeking approval of Stelara (ustekinumab) for the treatment of moderate to severe plaque psoriasis in pediatric patients ages 12 to 17 years old who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. Read more...

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Amgen's ALL Drug Receives FDA Priority Review

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

Amgen announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for the investigational bispecific T cell engager (BiTE) antibody construct, blinatumomab. Read more...

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The Dwindling Stock of Antibiotics, and What to Do About It

October 10, 2014 10:13 am | by Diana Lutz | News | Comments

The Centers for Disease Control and Prevention has said that at least 2 million Americans are sickened by antibiotic resistant infections each year and survive. Read more...                        

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Giant Step Toward New Diabetes Treatment

October 10, 2014 9:55 am | News | Comments

Harvard stem cell researchers announced that they have made a giant leap forward in the quest to find a truly effective treatment for type 1 diabetes, a condition that affects an estimated 3 million Americans at a cost of about $15 billion annually Read more...

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Canadian Ebola Vaccine to Be Shipped to Geneva Next Week, WHO Said

October 10, 2014 9:35 am | by Helen Branswell, The Canadian Press | News | Comments

Experimental Ebola vaccine that Canada has donated to the World Health Organization will be shipped to Geneva next week, the global health agency said. Read more...                                   

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Shaping the Future of Immunotherapy: Four Trends to Watch

October 10, 2014 8:30 am | by Merrilyn Datta, Ph.D., Chief Commercial Officer, Definiens | Articles | Comments

Just four years after the drug sipuleucel-T was approved for clinical adoption, the field of immunotherapy is on the cusp of a number of exciting advancements. Read more...                           

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NIH Invests Nearly $32M to Increase Utility of Biomedical Research Data

October 9, 2014 3:26 pm | News | Comments

Wide-ranging National Institutes of Health grants announced will develop new strategies to analyze and leverage the explosion of increasingly complex biomedical data sets, often referred to as Big Data. Read more...

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Cancer Drug Destroys Tumors in Pre-Clinical Trials

October 9, 2014 3:18 pm | News | Comments

Scientists at QIMR Berghofer Medical Research Institute have used an experimental drug produced from the seeds of a rainforest plant to cure solid cancer tumors in preclinical trials. Read more...                     

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Endo Intl to Buy Auxilium in Deal Worth $2.6B

October 9, 2014 3:09 pm | News | Comments

Ireland's Endo International is planning to buy Auxilium Pharmaceuticals in a sweetened cash-and-stock deal valued at $2.6 billion a few weeks after Auxilium rejected a lower bid. The Auxilium board embraced the latest offer but its shareholders get to vote on it. Read more...

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Purdue Pharma Launches Smaller Dosage of Chronic Pain Patch

October 9, 2014 3:03 pm | News | Comments

Purdue Pharma L.P. announced the U.S. commercial launch of the new 7.5 mcg/hour dosage strength of Butrans (buprenorphine) Transdermal System CIII. Five strengths of Butrans are now available: 5 mcg/hour, 7.5 mcg/hour, 10 mcg/hour, 15 mcg/hour and 20 mcg/hour. Read more...

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