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Daily news and top headlines for drug research professionals

New Drug Prevents Tumor Growth by Inhibiting Key Enzyme

April 4, 2014 10:19 am | Videos | Comments

A ground-breaking has shown that fast-growing cancer cells are sensitive towards imbalances in the metabolism of nucleotides, the building blocks of DNA. This vulnerability can be exploited for a radically novel antitumor therapeutic approach. Read more...

Astellas, Medivation Submit Amended MAA for New Xtandi Use

April 3, 2014 1:22 pm | News | Comments

Astellas Pharma and Medivation announced the submission of a variation to amend the European Marketing Authorization Application for Xtandi (enzalutamide) capsules for a new indication in the treatment of adult men with metastatic castration-resistant prostate cancer. Read more...

Study Helps Unravel the Tangled Origin of ALS

April 3, 2014 1:14 pm | News | Comments

By studying nerve cells that originated in patients with a severe neurological disease, a University of Wisconsin-Madison researcher has pinpointed an error in protein formation that could be the root of amyotrophic lateral sclerosis. Read more...

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Glenmark's Chronic Inflammatory Disease Drug Enters Human Trials

April 3, 2014 1:00 pm | News | Comments

Glenmark Pharmaceuticals announced that its Novel Chemical Entity (NCE) GRC 27864, a potent, selective, and orally bioavailable inhibitor of Microsomal Prostaglandin E synthase-1 (mPGES-1), is entering Phase 1human trials. Read more...   

FDA Accepts Omeros IND App for TMA Treatment

April 3, 2014 12:45 pm | News | Comments

Omeros Corp. announced that its Investigational New Drug (IND) Application to evaluate OMS721 for the inhibition of complement mediated thrombotic microangiopathies (TMAs) has been cleared by the U.S. Food and Drug Administration (FDA). Read more...

BioDelivery Sciences Opens Phase 3 Trial of Diabetic Neuropathy Gel

April 3, 2014 12:37 pm | News | Comments

BioDelivery Sciences International Inc. announced the enrollment of the first patient in the RHAPSODY Study, a Phase 3 clinical trial of Clonidine Topical Gel for the treatment of painful diabetic neuropathy. Read more...       

Fertility Drugs Do Not Increase Breast Cancer Risk

April 3, 2014 12:26 pm | News | Comments

Women who took clomiphene citrate or gonadotropins as a part of fertility treatment did not experience an increased risk for breast cancer over 30 years of follow-up, compared with women who were not treated with these medications, according to a study. Read more...

Gilead Hep C Combo Hits Primary Endpoint in Japan

April 3, 2014 11:10 am | News | Comments

Gilead Sciences announced top-line results from a Phase 3 clinical trial in Japan evaluating the once-daily nucleotide analog polymerase inhibitor sofosbuvir in combination with ribavirin for the treatment of genotype 2 chronic hepatitis C virus (HCV) infection. Read more...

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Ketamine Can Treat Severe Depression

April 3, 2014 10:33 am | News | Comments

New research confirmed that ketamine has a rapid antidepressant effect in some patients with severe depression who have not responded to other treatments. Read more...                        

How Personalized Medicine Works: Bioinformaticians to the Rescue

April 3, 2014 10:23 am | Videos | Comments

In our third video, Rob Fee is back to discuss how informatics can help to overcome one of the biggest challenges in personalized medicine: organizing and examining the mountains of data that are generated during the gene sequencing process. Rob's advice? Find a bioinformatician...fast!

Takeda Gets JPMA Suspension Over Candesartan Marketing

April 3, 2014 3:20 am | News | Comments

Takeda Pharmaceutical Co. Ltd. received notice of sanctions imposed by the Japan Pharmaceutical Manufacturers Association (JPMA) for promotional activities regarding Candesartan Antihypertensive Survival Evaluation in Japan (CASE-J). Read more...

Daiichi Sankyo, UCSF Partner on Neurodegenerative Drugs

April 2, 2014 9:19 pm | News | Comments

Daiichi Sankyo and UCSF announced that they have established a drug discovery collaboration focused on developing novel therapeutics and molecular diagnostics for multiple neurodegenerative diseases. Read more...           

Cognition Therapeutics Receives U.S. Patent for Alzheimer's Drug

April 2, 2014 3:25 pm | News | Comments

Patent describes the discovery of several candidate drug molecules which can stop the effects of the brain protein that appears to play a major role in development of Alzheimer's disease. Read more...          

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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...   

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...

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...

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...         

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...

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...

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...    

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...                 

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...

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...            

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...

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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