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DDD Update

Daily news and top headlines for drug research professionals

New Analyses Show Edoxaban Comparable to Warfarin

March 24, 2014 10:53 am | News | Comments

Daiichi Sankyo Co. Ltd. announced late-breaking data from two pre-specified subgroup analyses of East Asian patients with non-valvular atrial fibrillation (NVAF) or venous thromboembolism (VTE) enrolled in two Phase 3 edoxaban studies. Read more...

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Roche Chronic Hive Drug Gets FDA Green Light

March 24, 2014 10:42 am | News | Comments

Roche announced that the FDA approved Xolair (omalizumab) for the treatment of chronic idiopathic urticaria (CIU), a form of chronic hives, in people 12 years of age and older who remain symptomatic despite treatment with H1-antihistamine therapy. Read more...

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AstraZeneca Snags Forxiga Approval in Japan

March 24, 2014 10:03 am | News | Comments

AstraZeneca announced that the Japanese Ministry of Health, Labor and Welfare approved Forxiga (dapagliflozin) as a once-daily oral treatment for type 2 diabetes. Read more...                     

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Simeprevir for Hepatitis C Approved in Russia

March 24, 2014 9:50 am | News | Comments

Medivir AB announced that that the Russian Ministry of Health has approved Sovriad (simeprevir) for the treatment of chronic hepatitis C genotype 1 infection. Read more...                       

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FDA Approves Celgene's Specialty Arthritis Drug

March 24, 2014 9:40 am | News | Comments

The Food and Drug Administration on Friday said it approved Celgene Corp.'s drug Otezla to treat adults with psoriatic arthritis, a form of arthritis that causes joint pain, stiffness and swelling in patients with psoriasis. Read more...   

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Emmaus Sickle Cell Drug Hits Phase 3 Endpoints

March 21, 2014 3:04 pm | News | Comments

Emmaus Life Sciences Inc. announced that preliminary top-line results of its Phase 3 clinical trial evaluating the safety and efficacy of its treatment for sickle cell anemia and sickle beta-0 thalassemia met both the primary and secondary endpoints of the clinical trial. Read more...

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Endocyte Drug Slows Lung Cancer Progression

March 21, 2014 2:55 pm | News | Comments

Endocyte Inc. announced results from a Phase 2b trial, which showed that the study met the primary endpoint for the combination of vintafolide and docetaxel in folate receptor-positive recurrent non-small cell lung cancer patients. Read more...  

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Committee OKs Expanded Use of Novo Nordisk Drugs

March 21, 2014 2:44 pm | News | Comments

The Committee for Medicinal Products for Human Use (CHMP) issued positive opinions for expanded use of Tresiba (insulin degludec) and Victoza (liraglutide) in type 2 diabetes. Read more...                  

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Substance Makes Glioblastoma Cells Explode

March 21, 2014 2:39 pm | News | Comments

Researchers have discovered that a substance called Vacquinol-1 makes cells from glioblastoma, the most aggressive type of brain tumor, literally explode. When mice were given the substance, tumor growth was reversed and survival was prolonged. Read more...

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Investigational Drug Evaluated in Newborns with Rare Disorder

March 21, 2014 2:31 pm | News | Comments

Children with a rare genetic disorder that causes missing and malformed teeth, sparse hair and the inability to perspire are born without a key developmental protein. A clinical trial now underway aims to see if the void can be filled with replacement-protein therapy. Read more...

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Novartis Starting New Head-to-Head Psoriasis Trial

March 21, 2014 2:10 pm | News | Comments

Novartis announced that a new Phase 3b head-to-head study of IL-17A inhibitor secukinumab (AIN457) versus Stelara (ustekinumab) in moderate-to-severe plaque psoriasis has started patient enrollment. Read more..           

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Simeprevir for Hep C Closer to EU Approval

March 21, 2014 11:19 am | News | Comments

Medivir AB announced that the Committee for Medicinal Products for Human Use has adopted a positive opinion, recommending Marketing Authorization in the European Union for the use of simeprevir. in combination with other drugs, for the treatment of chronic hepatitis C. Read more...

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Takeda's UC, Crohn's Drug Gets OK from EU Committee

March 21, 2014 11:08 am | News | Comments

Takeda announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) has issued a positive opinion for Entyvio (vedolizumab) for the treatment of adults with ulcerative colitis (UC) and Crohn's disease (CD). Read more...

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Oral Chemotherapy Trial Launched in New Zealand

March 21, 2014 11:00 am | News | Comments

Kinex Pharmaceuticals announced that the company has received regulatory and ethics approvals to initiate the first clinical study of an oral form of paclitaxel (Oraxol) in Dunedin Hospital in Otago, New Zealand. Read more...        

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CHMP Recommends EU Approval of Empagliflozin for Diabetes

March 21, 2014 10:41 am | News | Comments

Boehringer Ingelheim and Eli Lilly and Co. announced a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, recommending approval of empagliflozin in adults with type 2 diabetes. Read more...

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