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DDD Update

Daily news and top headlines for drug research professionals

Committee Backs Approval of Afrezza, MannKind Oral Diabetes Drug

April 2, 2014 2:23 pm | News | Comments

MannKind Corporation announced that an FDA committee recommend that Afrezza Inhalation Powder be granted marketing approval by the FDA to improve glycemic control in adults with type 1 and type 2 diabetes. Read more...         

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Tetraphase Receives Fast Track Status for IV, Oral Eravacycline

April 2, 2014 1:57 pm | News | Comments

Tetraphase Pharmaceuticals Inc. announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track designations for both the intravenous (IV) and oral formulations of the company's lead antibiotic candidate, eravacycline. Read more...

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Daiichi Sankyo Expands European Atrial Fibrillation Registry

April 2, 2014 10:43 am | News | Comments

Daiichi Sankyo announced it will extend the PREvention oF thromboembolic events- European Registry in Atrial Fibrillation (PREFER in AF), which will include a specific focus on the use of Novel Oral Anticoagulant therapy, including prescribing patterns. Read more...

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Bayer Launches Phase 3 Prostate Cancer Trial

April 2, 2014 10:35 am | News | Comments

Bayer HealthCare announced that the company has begun to enroll patients in a new Phase 3 trial with radium-223 dichloride (Xofigo) to evaluate radium-223 in combination with abiraterone acetate and prednisone/prednisolone. Read more...    

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EMA App Withdrawn for GSK Ovarian Cancer Drug

April 2, 2014 10:28 am | News | Comments

GlaxoSmithKline announced that it has withdrawn its application to the European Medicines Agency (EMA) for a variation to the Marketing Authorization for Votrient (pazopanib). Read more...                 

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Janssen Hep C Combo Therapy Moves to Phase 3

April 2, 2014 10:21 am | News | Comments

Janssen R&D Ireland announced that two Phase 3 trials are recruiting patients to examine the efficacy and safety of simeprevir in combination with sofosbuvir for the treatment of chronic genotype 1 hepatitis C virus (HCV) infection. Read more...

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Merck Serono in Biomarker Collaboration with Pfizer, Broad Institute

April 2, 2014 10:10 am | News | Comments

Merck Serono, the biopharmaceutical division of Merck, announced that its U.S. affiliate EMD Serono has signed a research agreement with Pfizer Inc. and the Broad Institute in Cambridge, Mass.  Read more...            

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GSK Ends Lung Cancer Immunotherapy Trial

April 2, 2014 9:58 am | News | Comments

GlaxoSmithKline announced the company will stop its current trial of MAGE-A3 in non-small cell lung cancer patients, after establishing that it will not be possible to identify a sub-population of gene-signature positive NSCLC patients that may benefit from the treatment. Read more...

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Committee Backs Approval of Cubist Antibiotic for Skin Infection

April 1, 2014 2:34 pm | News | Comments

Cubist Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) Anti-Infective Drugs Advisory Committee (AIDAC) voted to recommend approval of Cubist’s investigational antibiotic Sivextro (tedizolid phosphate). Read more...

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Court Backs Lilly’s Alimta Patent Until 2022

April 1, 2014 2:25 pm | News | Comments

A federal court has upheld a patent that protects an Eli Lilly lung cancer treatment from cheaper generic competition until 2022. The patent protects a vitamin treatment regimen given before the drug, Alimta, is administered to prevent side effects. Read more...

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Celgene, Forma Announce Multi-Year Strategic Alliance

April 1, 2014 2:13 pm | News | Comments

Forma Therapeutics, an R&D organization in pursuit of medicines in oncology and other therapeutic areas, announced a second strategic collaboration and option agreement with Celgene Corp. Read more...        

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Immunovaccine, Pfenex Post Positive Anthrax Vaccine Results

April 1, 2014 1:58 pm | News | Comments

Immunovaccine Inc. and Pfenex Inc. announced positive results from anthrax challenge studies in rabbits using Pfenex's mutant recombinant Protective Antigen (mrPA) formulated with Immunovaccine's DepoVax delivery system. Read more...   

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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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