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DDD Update

Daily news and top headlines for drug research professionals

EU Approves Two-Dose Gardasil for Early Teens

April 8, 2014 10:29 am | News | Comments

Sanofi Pasteur MSD announced that the European Commission has granted marketing authorization for its quadrivalent HPV vaccine, Gardasil, for a two-dose schedule at zero and six months in children aged from nine to 13 years. Read more...   

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Merck Serono Begins Phase 3 NSCLC Trial of Tecemotide

April 8, 2014 10:19 am | News | Comments

Merck Serono announced the initiation of the Phase 3 START2 study, designed to assess the efficacy and safety of its investigational MUC1 antigen-specific cancer immunotherapy tecemotide in patients with advanced Stage III non-small cell lung cancer. Read more...

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Alkermes' Schizophrenia Drug Hits Key Phase 3 Endpoints

April 8, 2014 10:05 am | News | Comments

Alkermes plc announced positive top-line results from a randomized, double-blind, placebo-controlled Phase 3 clinical trial of aripiprazole lauroxil in patients with schizophrenia. Read more...                 

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Takeda, Lilly Face Penalty over Actos Cancer Cases

April 8, 2014 9:25 am | by Yuri Kageyama, AP Business Writer | News | Comments

A U.S. jury ordered Japanese drugmaker Takeda Pharmaceutical Co. and Eli Lilly and Co. to pay $9 billion in punitive damages over a diabetes medicine linked to cancer. The drug companies said they will "vigorously challenge" the decision. Read more...

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New Drug May Benefit Head, Neck Cancer Patients

April 8, 2014 8:30 am | News | Comments

Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) may benefit from treatment with the investigational drug dacomitinib if their cancer has no defects in a cell signaling pathway called the PI3K pathway and no signs of excessive inflammation. Read more...

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Gilead Hep C Combo Gets Breakthrough Therapy Status, Priority Review from FDA

April 7, 2014 2:21 pm | News | Comments

Gilead Sciences Inc. announced that the FDA has granted priority review and a Breakthrough Therapy designation to the comapny's fixed-dose combination of ledipasvir and sofosbuvir for the treatment of chronic hepatitis C genotype 1. Read more...

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Ambit Initiates Phase 2 Trial of Quizartinib Combo in AML, MDS

April 7, 2014 2:14 pm | News | Comments

Ambit Biosciences announced the initiation of the Phase 2 cohort of a Phase 1/2 study of quizartinib in combination with either 5-azacitidine or low dose cytarabine for previously untreated FLT3-ITD positive acute myeloid leukemia patients, or FLT3-ITD positive AML patients in first relapse. Read more...

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FDA Approves Pradaxa for DVT, Pulmonary Embolism

April 7, 2014 2:09 pm | News | Comments

Boehringer Ingelheim announced that the FDA has approved Pradaxa for the treatment of DVT and PE in patients who have been treated with a parenteral anticoagulant for five to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated. Read more...

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Antibody-Drug Conjugate Benefits Melanoma Patients in Phase 1

April 7, 2014 2:00 pm | News | Comments

The investigational drug DEDN6525A, which is a new member of a class of drugs called antibody-drug conjugates, was safe, tolerable, and showed hints of activity against three different forms of melanoma. Read more...          

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New Lilly Drug Promising Against Metastatic Breast Cancer

April 7, 2014 1:48 pm | News | Comments

The new oral drug LY2835219, an inhibitor of cyclin-dependent kinases 4 and 6, showed early promise as monotherapy for patients with metastatic breast cancer, particularly for those with hormone receptor-positive disease. Read more...     

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Novartis Men B Vaccine Gets Breakthrough Designation from FDA

April 7, 2014 1:38 pm | News | Comments

Novartis announced that Bexsero (Meningococcal Group B Vaccine) has received a Breakthrough Therapy designation-the fourth such designation for Novartis-from the FDA. Read more...       

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CRT, Teva Collaboration IDs New Cancer Drug Candidate

April 7, 2014 10:41 am | News | Comments

Cancer Research Technology announced a successful outcome to their existing collaboration with Teva through the identification of a novel atypical Protein Kinase C (aPKC) inhibitor pre-clinical candidate, licensed by Teva. Read more...     

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Roche Buys Orphan Drug Molecule from Oryzon

April 7, 2014 10:35 am | News | Comments

Roche and Oryzon Genomics SA announced they have entered into a worldwide collaboration to research, develop and commercialize inhibitors of Lysine Specific Demethylase-1, an epigenetic modulator that regulates gene expression. Read more...   

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Pfizer's New Breast Cancer Drug Shows Promise

April 7, 2014 8:30 am | by Christopher S. Rugaber, AP Economics Writer | News | Comments

An experimental drug has shown encouraging results in treating advanced breast cancer in an early clinical trial, pharmaceutical giant Pfizer reported Sunday. The drug prevented breast cancer from worsening for 20.2 months in trial. Read more...

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Meda Turns Down Mylan's Merger Proposal

April 7, 2014 8:30 am | News | Comments

Swedish drug company Meda has rebuffed an approach from generic drug maker Mylan which was looking to combine the two businesses. Meda AB says talks between the two companies have stopped "without further actions." Read more...       

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