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DDD Update

Daily news and top headlines for drug research professionals

Cell Metabolism Discovery May Lead to Cancer, Cold Treatments

April 2, 2014 3:12 pm | News | Comments

Scientists at UCLA's Jonsson Comprehensive Cancer Center have published the first study explaining in detail how viruses reprogram the metabolism of the cells they invade to promote continued viral growth within an organism. Read more...   

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FDA Gives Go-Ahead for Phase 2a Trial of CardioCell CHF Stem Cell Therapy

April 2, 2014 3:02 pm | News | Comments

CardioCell LLC has just received the FDA’s investigational new drug (IND) approval for a United States-based, Phase 2a clinical study using its allogeneic stem-cell therapy to treat subjects with chronic heart failure (CHF), which generates more than one million hospitalizations annually. Read more...

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FDA Approves First Hay Fever Immunotherapy Tablet

April 2, 2014 2:42 pm | by Linda Johnson, AP Business Writer | News | Comments

The Food and Drug Administration said Wednesday that it has approved the first tablet in the U.S. for gradually reducing hay fever symptoms, an alternative to months of weekly doctor visits for uncomfortable allergy-desensitizing shots. Read more...

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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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