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DDD Update

Daily news and top headlines for drug research professionals

Janssen Submits NDA for New HIV Combo Drug

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

Janssen Research & Development LLC announced it has submitted a New Drug Application to the FDA seeking approval for a once-daily fixed-dose antiretroviral combination tablet containing darunavir, a protease inhibitor, with cobicistat, an investigational pharmacokinetic enhancer or boosting agent developed for use in combination with other human immunodeficiency virus (HIV-1) medicines. Read more...

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Experimental Cancer Drug Reverses Schizophrenia in Mice

April 1, 2014 1:17 pm | News | Comments

Johns Hopkins researchers say that an experimental anticancer compound appears to have reversed behaviors associated with schizophrenia and restored some lost brain cell function in adolescent mice with a rodent version of the devastating mental illness. Read more...

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Takeda in Licensing Agreement for Trianni Mouse Platform

April 1, 2014 10:47 am | News | Comments

Trianni Inc. and Takeda Pharmaceutical Co. Ltd. jointly announced that they have entered into a license agreement for Takeda’s use of the Trianni Mouse, a monoclonal antibody discovery platform. Read more...             

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Actavis Acquires Thailand's Silom Medical for $100M

April 1, 2014 10:38 am | News | Comments

Drugmaker Actavis Plc plans to expand its reach into Southeast Asia by spending about $100 million to buy Silom Medical Co., a generic pharmaceutical company focused on Thailand. Read more...                 

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Sanofi-Regeneron Cholesterol Drug Excels in Japanese Trial

April 1, 2014 10:24 am | News | Comments

Sanofi and Regeneron announced that the first Phase 2 study with alirocumab, an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9), in Japanese patients met its primary endpoint. Read more...     

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Bayer Launches Phase 3 Blood Clot Drug Trials

April 1, 2014 9:50 am | News | Comments

Bayer HealthCare and its U.S. development partner Janssen Research & Development LLC announced the initiation of two new Phase 3 trials to evaluate rivaroxaban in medically-ill patients and children at high risk for blood clots. Read more...

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Daiichi Sankyo Initiates Phase 3 Edoxaban Study

April 1, 2014 9:26 am | News | Comments

Daiichi Sankyo Co. Ltd. announced that it has started enrolling patients into the ENSURE-AF multinational Phase 3 study, which will evaluate edoxaban compared to enoxaparin/warfarin for the prevention of stroke and other blood clot complications in patients with non-valvular atrial fibrillation undergoing electrical cardioversion. Read more...

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New Initiative Aims to Improve Outcomes in Metastatic Colorectal Cancer

April 1, 2014 8:53 am | News | Comments

Merck Serono, the biopharmaceutical division of Merck, announced the formation of the global Oncology Partnership and Education Network (OPEN). Read more...                

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Halozyme’s Diabetes Drug Meets Primary Endpoint

March 31, 2014 3:54 pm | News | Comments

Halozyme Therapeutics Inc. announced that the primary endpoint of non-inferiority of A1C levels at six months was met for the CONSISTENT 1 trial. Read more...                            

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Isis Antisense Drug Effectively Lowers Triglycerides in Phase 2

March 31, 2014 3:49 pm | News | Comments

Isis Pharmaceuticals Inc. announced the final results from its Phase 2 study of ISIS-APOCIIIRx in patients with high to severely high triglycerides on stable doses of fibrates. Read more...                  

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FDA Grants Orphan Designation to Kite Cancer Immunotherapy

March 31, 2014 3:45 pm | News | Comments

Kite Pharma Inc. announced that the FDA granted orphan drug designation for the company's autologous engineered T cell product that targets CD19 expression on B cell malignancies, for the treatment of diffuse large B cell lymphoma (DLBCL). Read more...

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Janssen Expands Global Cardiovascular Research with Three New Xarelto Studies

March 31, 2014 3:42 pm | News | Comments

Janssen Research & Development LLC (Janssen) announced it is adding three new clinical trials to its EXPLORER global cardiovascular research program for Xarelto, the most studied and broadly indicated oral Factor Xa inhibitor in the world. Read more...

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Supreme Court Takes Up Teva Dispute

March 31, 2014 3:38 pm | News | Comments

The Supreme Court is wading into a patent dispute between rival pharmaceutical companies over the multiple sclerosis treatment Copaxone. Read more...                            

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Studies Find New Drugs Greatly Lower Cholesterol

March 31, 2014 3:21 pm | by Marilynn Marchione , AP Chief Medical Writer | News | Comments

A new class of experimental medicines can dramatically lower cholesterol, raising hopes of a fresh option for people who can't tolerate or don't get enough help from Lipitor and other statin drugs that have been used for this for decades. Read more...

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Adempas Approved in EU for Life-Threatening Hypertension

March 31, 2014 10:49 am | News | Comments

Bayer announced that Adempas (riociguat) has been approved by the European Commission for the treatment of chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension. Read more...             

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