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DDD Update

Daily news and top headlines for drug research professionals

Personalized Immunotherapy for Leukemia Named Breakthrough Therapy

July 7, 2014 2:36 pm | News | Comments

A University-developed personalized immunotherapy was awarded the FDA's Breakthrough Therapy designation for the treatment of relapsed and refractory adult and pediatric acute lymphoblastic leukemia. The therapy, known as CTL019, is the first personalized cellular therapy for the treatment of cancer to receive this classification. Read more...

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NIH Awards SBIR Grant for Epigenetic Database

July 7, 2014 2:25 pm | News | Comments

Reaction Biology Corp. (RBC) announced that it has been awarded a Phase 1 SBIR grant from the National Center for Advancing Translational Sciences to create a database of epigenetic drug interactions. Read more...           

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Hepatocellular Carcinoma Drug Gets Orphan Designation

July 7, 2014 2:13 pm | News | Comments

CASI Pharmaceuticals Inc. announced that its orally-active, Aurora A/angiogenic kinase inhibitor, ENMD-2076, has received Orphan Drug designation from the FDA for the treatment of hepatocellular carcinoma. Read more...         

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Animal Vaccines Should Guide Malaria Research

July 7, 2014 2:07 pm | News | Comments

Research into vaccines for malaria in humans should be guided by the success shown in producing effective vaccines for malaria-like diseases in animals, according to a new study. Read more...                  

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99% of Alzheimer's Drug Trials Fail, Study Says

July 7, 2014 1:53 pm | News | Comments

Researchers have conducted the first-ever analysis of clinical trials for Alzheimer’s disease (AD), revealing an urgent need to increase the number of agents entering the AD drug development pipeline and progressing successfully towards new therapy treatments. Read more...

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Chronic Pain Drug Pushes Through Phase 3

July 7, 2014 12:47 pm | News | Comments

Endo Pharmaceuticals Inc. and BioDelivery Sciences International Inc. announced positive top-line results from its pivotal Phase 3 efficacy study of BEMA buprenorphine in opioid-experienced patients. Read more...            

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Diabetes Drug Receives MMA in Japan

July 7, 2014 11:23 am | News | Comments

Mitsubishi Tanabe Pharma Corp. and Daiichi Sankyo Co. Ltd., announced that Mitsubishi Tanabe Pharma has received approval to manufacture and market the SGLT2 inhibitor, Canaglu tablets (canagliflozin hydrate) 100 mg in Japan, for the treatment of patients with type 2 diabetes mellitus. Read more...

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BioDelivery’s Pain Drug Better than Placebo, Stocks Soar

July 7, 2014 11:17 am | News | Comments

Shares of BioDelivery Sciences International - a Raleigh, North Carolina, company - surged Monday before markets opened and after the drug developer said its potential severe pain treatment fared better than a placebo, or fake drug, in another late-stage study. Read more...

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Japan First to Approve Alectinib for ALK+ NSCLC

July 7, 2014 11:11 am | News | Comments

Roche announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved alectinib for the treatment of people living with non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase fusion gene-positive (ALK+). Read more...

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Pseudogenes May Help in the Discovery of Biomarkers

July 7, 2014 11:06 am | News | Comments

Alas, the thankless pseudogene: dysfunctional, unloved and seemingly of little use, these poor-cousin relatives of genes have lost their protein-coding abilities, contain material not essential for an organism’s survival and are the “last stop” for removal of genomic waste. Read more...

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MRC Technology, AstraZeneca Renew Drug Target Collaboration

July 7, 2014 10:57 am | News | Comments

MRC Technology and AstraZeneca announced the renewal of their strategic collaboration which focuses on the identification and selection of novel drug targets with the potential to become potent and selective therapeutics for the treatment of serious disease in the areas of oncology, inflammation and diabetes. Read more...

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U.S. Officials Barred from Americans’ Trial in China

July 7, 2014 10:51 am | News | Comments

U.S. diplomats will be barred from the trial in China of an American investigator for GlaxoSmithKline and her British husband who are charged with improperly selling personal information, a spokesman for the U.S. Embassy in Beijing said Friday. Read more...

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BI Gets Priority Review for IPF Drug

July 3, 2014 12:00 pm | News | Comments

Boehringer Ingelheim announced that the New Drug Application for its investigational compound nintedanib has been accepted for filing by the FDA and granted Priority Review designation. Read more...                

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FDA Grants Orphan Designation to Galderma’s Skin Disease Drug

July 3, 2014 12:00 pm | News | Comments

Galderma announced that the U.S. Food and Drug Administration granted Orphan Drug Designation status for the company’s trifarotene molecule for the treatment of congenital ichthyosis. Read more...               

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Insys Cannabidiol Snags Orphan Designation for Rare Epilepsy

July 3, 2014 12:00 pm | News | Comments

Insys Therapeutics Inc. announced that the FDA has granted orphan drug designation to its pharmaceutical cannabidiol (CBD) for the treatment of Dravet syndrome, a rare pediatric-onset epilepsy. Read more...             

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