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Daily news and top headlines for drug research professionals

Novartis Extends Trial Data Transparency

February 26, 2014 10:45 am | News | Comments

Novartis announced that to extend clinical trial data transparency, the company will now provide patient-level data on newly approved innovative medicines to those researchers who request it. Read more...           

InterMune Considers NDA Submission after Positive Lung Drug Trial

February 25, 2014 2:55 pm | News | Comments

InterMune Inc. announced that top-line data from a Phase 3 trial evaluating pirfenidone in patients with idiopathic pulmonary fibrosis (IPF) demonstrated a significant reduction in IPF disease progression. Read more...          

Lilly Diabetes Drug Hits Late-Stage Goal

February 25, 2014 11:10 am | News | Comments

Eli Lilly and Co.'s experimental injectable diabetes treatment dulaglutide fared on par in a late-stage study with another drug that's already on the market. Read more...                       

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FDA OKs Label Update for Pfizer's Xeljanz

February 25, 2014 10:31 am | News | Comments

Pfizer Inc. announced that the FDA has approved a supplemental New Drug Application to update the current label of Xeljanz 5 mg tablets to include radiographic data from two Phase 3 studies. Read more...             

Isis Pharmaceuticals SMA Drug Excels in Phase 2

February 24, 2014 2:14 pm | News | Comments

Isis Pharmaceuticals Inc. provided an update on its ongoing open label, multiple dose, Phase 2 study of ISIS-SMNRx in infants with spinal muscular atrophy (SMA). Read more...                     

Pfizer Vaccine Prevents Pneumonia in Older Adults

February 24, 2014 12:46 pm | News | Comments

Pfizer Inc. today announced that the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA) achieved its primary clinical objective and both secondary clinical objectives. Read more...               

Omega 3, Antidepressants May Curb Dementia Symptoms

February 24, 2014 10:54 am | News | Comments

A new study is looking into the effectiveness of omega-3 supplements and the antidepressant, sertraline, in reducing depressive symptoms and cognitive decline in older people, in a bid to prevent the onset of depression and dementia in later life. Read more...

Eisai to Launch New, Global Belviq Trial

February 24, 2014 10:25 am | News | Comments

Eisai Inc. announced that patient recruitment and enrollment are currently underway for a randomized double-blind, placebo-controlled outcomes trial to evaluate the effect of long-term treatment with Belviq on the incidence of major adverse cardiovascular events and new onset type 2 diabetes mellitus. Read more...

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Subanalysis Shows Consistent Results for Eliquis versus Warfarin

February 21, 2014 2:21 pm | News | Comments

Bristol-Myers Squibb Co. and Pfizer Inc. announced results of a pre-specified subanalysis of the Phase 3 ARISTOTLE trial in relation to patient age. Read more...                         

Janssen Initiates Phase 3 Study to Slow Diabetic Nephropathy

February 21, 2014 10:45 am | News | Comments

Janssen Research & Development LLC announced the initiation of CREDENCE, a global, multicenter study of Invokana in patients with type 2 diabetes and diabetic nephropathy. Read more...                 

Antares Posts Positive Results from Testosterone Study

February 20, 2014 2:57 pm | News | Comments

Antares Pharma Inc. announced positive results from a multi-center Phase 2 clinical study evaluating the pharmacokinetic profile of testosterone enanthate in testosterone deficient adult males. Read more...              

Oncothyreon, Array BioPharma Launch Breast Cancer Trial

February 20, 2014 2:47 pm | News | Comments

Oncothyreon Inc. and Array BioPharma Inc. announced the initiation of a Phase 1b trial of ONT-380 in combination with Kadcyla in patients with metastatic HER2+ breast cancer. Read more...                  

Huntington's Drug Shows Promise for Slowing Disease Progression

February 20, 2014 11:02 am | News | Comments

Raptor Pharmaceutical Corp. announced top-line results from a planned 18-month analysis of an ongoing three-year Phase 2/3 clinical trial of RP103 (delayed-release cysteamine) for the potential treatment of Huntington's disease. Read more...   

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Bayer Launches New Phase 3 Stivarga Trial

February 20, 2014 10:47 am | News | Comments

Bayer HealthCare announced that the company has begun to enroll patients in the COAST trial studying regorafenib (Stivarga) tablets in colorectal cancer (CRC) patients with resected liver metastases. Read more...           

New Therapy Targets Prospective Older Bone Marrow Transplant Patients

February 20, 2014 9:45 am | by Kaushik J. Dave, Ph.D. | Articles | Comments

Bone marrow transplants are the only potential cure for many blood cancers in older patients, but many in this group are ruled ineligible because the procedure is often deemed too harsh for older people. Since more than half of AML patients are over 65 years old, new tactics to prepare these patients for hematopoietic stem cell transplantation are needed.

Omeros Cognition Drug Trial Kicks Off

February 19, 2014 2:30 pm | News | Comments

Omeros Corp. announced dosing of the first patient in a second Phase 2 clinical trial of OMS824, the company's phosphodiesterase 10 inhibitor being developed for the treatment of schizophrenia, Huntington's disease (HD) and other cognitive disorders. Read more...

Lilly Biologic Drug Boosts Lung Cancer Survival

February 19, 2014 12:10 pm | by Linda A. Johnson, AP Business Writer | News | Comments

Eli Lilly & Co. shares rose Wednesday after the drugmaker said previously treated patients with a type of lung cancer who took its experimental drug survived longer than those in a comparison group in a late-stage test of the drug. Read more..

CardioCell AMI Therapy Trials Launch in U.S., Kazakhstan

February 19, 2014 11:08 am | News | Comments

CardioCell LLC announces two new clinical trials using its allogeneic stem-cell therapy to treat subjects with acute myocardial infarction (AMI), a problem facing more than 1.26 million Americans annually.  Read more...       

Novartis Cancer Drug Meets Primary Endpoint in Phase 2

February 19, 2014 10:13 am | News | Comments

Novartis announced that the pivotal trial of the investigational oral compound LDE225 (sonidegib) in advanced basal cell carcinoma met its primary endpoint of demonstrating an objective response rate among patients within six months of treatment. Read more...

Microbiome Reports Diabetes Drug Trial Results

February 18, 2014 3:06 pm | News | Comments

MicroBiome Therapeutics (MBT) LLC announced positive top-line results from the company’s clinical trial of lead microbiome modulator NM504 in development for type 2 diabetes and prediabetes. Read more...              

Prana Huntington's Drug Shows Success in Phase 2

February 18, 2014 2:36 pm | News | Comments

Prana Biotechnology announced the results of its Reach2HD Phase 2 clinical trial investigating PBT2 as a treatment for Huntington disease. Read more...                             

Hemophilia Drug Hits Phase 3 Endpoints

February 18, 2014 10:34 am | News | Comments

Bayer HealthCare announced positive results from the PROTECT VIII trial evaluating the company’s investigational site-specific PEGylated recombinant human factor VIII compound BAY94-9027. Read more...

Bayer Initiates Phase 3 VTE Prevention Study with Rivaroxaban

February 18, 2014 10:24 am | News | Comments

Bayer HealthCare announced the initiation of a Phase 3 clinical trial that will evaluate two doses of its once-daily novel oral anticoagulant Xarelto against acetylsalicylic acid (ASA) for the long-term, secondary prevention of symptomatic venous thromboembolism (VTE). Read more...

Topiramate Reduces Heavy Drinking

February 14, 2014 2:49 pm | News | Comments

Researchers have shown that the anticonvulsant medication topiramate, previously shown to reduce drinking in patients committed to abstinence from alcohol, can also be helpful in treating problem drinkers whose aim is to curb their alcohol consumption. Read more...

Biopharma Services Launches Full Research Services Platform

February 14, 2014 2:33 pm | News | Comments

Biopharma Services Inc. is pleased to announce that in collaboration with its sister company, ADA Medical Ltd., it can now offer a complete range of contract research services, from early pre-clinical drug development through clinical trials. Read more...

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