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Daily news and top headlines for drug research professionals

BDSI Reports 'Encouraging' Results from Phase 3 Analysis

August 6, 2014 3:31 pm | News | Comments

BioDelivery Sciences International Inc. announced that it has completed a pre-specified interim analysis of the ongoing initial pivotal Phase 3 trial for Clonidine Topical Gel for the treatment of painful diabetic neuropathy (PDN). Read more...  

Oxygen, Imperial College London Collaborate on Organ Failure Trial

August 6, 2014 10:56 am | News | Comments

Oxygen Biotherapeutics Inc. announced a collaboration with Imperial College London to provide supplemental funding to support the accelerated enrollment and completion of the ongoing LeoPARDS Trial awarded by the Efficacy and Mechanism Evaluation Programme and funded by the Medical Research Council and managed by the National Institute for Health Research. Read more...

Psoriasis, RA Drug Shows Good Efficacy

August 6, 2014 10:45 am | News | Comments

Can-Fite BioPharma Ltd., a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, announced new data from a retrospective analysis of its autoimmune disease advanced trials that shows high efficacy of its orally bioavailable drug CF101. Read more...

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EU Approves Avastin for Ovarian Cancer

August 6, 2014 10:24 am | News | Comments

Roche announced that the European Commission approved the use of Avastin (bevacizumab) in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin chemotherapy as a treatment for women with recurrent ovarian cancer that is resistant to platinum-containing chemotherapy. Read more...

Paclitaxel Reformulated for Bolus Intraperitoneal Injection

August 5, 2014 2:30 pm | News | Comments

A repurposed drug originally used to treat ovarian cancer saw positive results for patients with advanced peritoneal cancers during a phase 1 clinical trial at The University of Kansas Cancer Center, during which it was administered as a bolus injection directly into the peritoneum through a catheter. Read more...

Novimmune to Start Proof of Concept Study for RA Drug

August 5, 2014 11:02 am | News | Comments

Novimmune SA announced the completion of a comprehensive Phase 1 clinical trial investigating the pharmacokinetics, pharmacodynamics, preliminary tolerability and safety of NI-0101, a first-in-class monoclonal antibody against toll-like receptor 4, in presence and absence in vivo of a TLR4 ligand. Read more...

Parkinson's Drug Eligible for EU Centralized Procedure

August 5, 2014 10:57 am | News | Comments

NeuroDerm Ltd. announced that the European Medicines Agency has deemed ND0612H, its product candidate offering continuous delivery of levodopa/carbidopa treatment for advanced Parkinson's disease, eligible for a European Union marketing authorization application procedure ("centralized procedure"). Read more...

Muscular Dystrophy Drug Conditionally Approved

August 5, 2014 10:47 am | News | Comments

PTC Therapeutics Inc. announced that the European Commission has granted conditional marketing authorization for Translarna (ataluren), in the European Union for the treatment of nonsense mutation Duchenne muscular dystrophy in ambulatory patients aged five years and older. Read more...

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Isis Initiates Phase 3 Infant SMA Study

August 4, 2014 2:40 pm | News | Comments

Isis Pharmaceuticals Inc. announced the initiation of a pivotal Phase 3 study evaluating ISIS-SMNRx in infants with spinal muscular atrophy (SMA), the most common genetic cause of infant mortality. Read more...           

Jentadueto Gets Label Update with New Trial Info

August 4, 2014 2:27 pm | News | Comments

The U.S. Prescribing Information for Jentadueto tablets now includes clinical trial data that showed linagliptin co-administered with metformin provided statistically significant decreases in blood glucose compared with linagliptin alone. Read more...

Final Patient Treated in Phase 2 ALS Stem Cell Trial

August 4, 2014 2:06 pm | News | Comments

Neuralstem Inc. announced that the final patient was treated in its Phase 2 trial using NSI-566 spinal cord-derived neural stem cells in the treatment of amyotrophic lateral sclerosis, ALS or Lou Gehrig's disease. Read more...       

Multiple Myeloma Drug Meets Primary Endpoint

August 4, 2014 10:37 am | News | Comments

Amgen and its subsidiary, Onyx Pharmaceuticals, announced that a planned interim analysis demonstrated that the Phase 3 clinical trial ASPIRE (CArfilzomib, Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma) met its primary endpoint of progression-free survival. Read more...

Thyroid Cancer Drug Approved for Accelerated Assessment

July 31, 2014 1:59 pm | News | Comments

The European Medicines Agency has approved Eisai's request for accelerated assessment of the investigational oral multiple receptor tyrosine kinase inhibitor lenvatinib, for the treatment of patients with progressive radioiodine-refractory, differentiated thyroid cancer. Read more...

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AFFiRiS, MJFF Make Progress on Parkinson's Vaccine

July 31, 2014 1:56 pm | News | Comments

AFFiRiS announced results of a Phase 1 clinical trial of PD01A, a vaccine against Parkinson's disease. PD01A is the first therapy against the protein alpha-synuclein, a promising Parkinson's drug target, to enter clinical testing. Read more...   

Kala Initiates Phase 2 Eye Drug Trials

July 31, 2014 1:43 pm | News | Comments

Kala Pharmaceuticals Inc. announced the initiation of two Phase 2 clinical trial to evaluate KP-121, the company’s loteprednol etabonate MPP (LE-MPP) drug product. Read more...                     

Cholesterol Drug Hits Primary Endpoint in Nine Trials

July 31, 2014 9:41 am | News | Comments

Sanofi and Regeneron announced that nine new Phase 3 ODYSSEY trials of alirocumab in people with hypercholesterolemia met their primary efficacy endpoint of a greater percent reduction from baseline in low-density lipoprotein cholesterol at 24 weeks compared to placebo or active comparator. Read more...

Naltrexone May Diminish ICD Symptoms in Parkinson's Patients

July 31, 2014 9:34 am | News | Comments

A team of investigators conducted a pilot study and found that the opioid antagonist naltrexone may be an effective treatment for diminishing symptoms of impulse control disorders (ICDs) in Parkinson's disease patients. Read more...    

France is 17th Country to Allow Patient Enrollment in Head, Neck Cancer Trial

July 31, 2014 8:44 am | News | Comments

CEL-SCI Corp. announced that the French Agency for the Safety of Health Products has cleared the company to commence patient enrollment for its Phase 3 Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine (Leukocyte Interleukin, Injection) in France. Read more...

Protein May Prevent Antibody-Mediated Transplant Rejection

July 31, 2014 8:40 am | News | Comments

A study presented at the 2014 World Transplant Congress evaluated the safety and efficacy of CSL Behring's C1 Inhibitor (C1-INH) concentrate in preventing antibody-mediated rejection following kidney transplants in highly sensitized patients. Read more...

Diabetes Drugs Get Positive CHMP Opinions for CV Safety Updates

July 30, 2014 10:58 am | News | Comments

Takeda Pharmaceuticals International GmbH announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued positive opinions for updates to the Summary of Product Characteristics for Vipidia and the fixed-dose combination therapies Vipdomet and Incresync. Read more...

AstraZeneca, Kyowa Hakko Kirin Partner on Immuno-Oncology Study

July 30, 2014 10:48 am | News | Comments

AstraZeneca announced that it has entered into a clinical study collaboration with Kyowa Hakko Kirin for a Phase 1/1b immuno-oncology study that will evaluate the safety and efficacy of two separate combinations of three investigational compounds in multiple solid tumors. Read more...

European Commission Approves Eliquis for DVT, PE

July 30, 2014 10:37 am | News | Comments

Bristol-Myers Squibb Co. and Pfizer Inc. announced that the European Commission has approved Eliquis (apixaban) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and the prevention of recurrent DVT and PE in adults. Read more...

Neurotrope Initiates Phase 2a Alzheimer's Treatment Study

July 29, 2014 2:48 pm | News | Comments

Neurotrope Inc. announced that it has initiated a Phase 2a clinical trial to evaluate bryostatin for the treatment of patients with Alzheimer's disease (AD). Read more...                       

Forced Mutations Doom HIV

July 29, 2014 2:32 pm | News | Comments

Fifteen years ago, researchers thought if they could induce the HIV virus to mutate uncontrollably, they could force it to weaken and eventually die out. But in a 2011 clinical trial, a drug based on this method did not eliminate the virus from patients. Now, researchers are aiming to develop better versions of that drug. Read more...

Glaucoma Drug Gets EU Approval

July 29, 2014 11:18 am | News | Comments

Alcon, the global leader in eye care and a division of Novartis, announced that Simbrinza eye drops suspension has been approved by the European Commission to decrease elevated intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension, for which monotherapy provides insufficient IOP reduction. Read more...

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