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Daily news and top headlines for drug research professionals

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...       

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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...

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...

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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...

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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...

European Commission Approves Leukemia Drug

July 29, 2014 11:04 am | News | Comments

Roche announced that the European Commission has approved Gazyvaro (obinutuzumab) in combination with chlorambucil chemotherapy for the treatment of people with previously untreated chronic lymphocytic leukemia who have comorbidities making them unsuitable for an intensive therapy (full-dose fludarabine based therapy). Read more...

Merck Serono Kicks Off Study of Merkel Cell Carcinoma Drug

July 29, 2014 10:59 am | News | Comments

Merck Serono, the biopharmaceutical division of Merck, announced the initiation of an international Phase 2 study designed to assess the efficacy and safety of MSB0010718C, an investigational fully human IgG1 monoclonal antibody that binds to programmed death-ligand 1 (PD-L1). Read more...

Cancer Drug Shows Promise as Infertility Treatment

July 28, 2014 12:26 pm | News | Comments

Physicians may have a new drug to treat infertility in women with polycystic ovary syndrome, according to a national, multi-center clinical trial. Read more...                          

HIV Inhibitor May Also Block Herpes Infection

July 28, 2014 12:19 pm | News | Comments

Creating a successful vaccine against two members of the herpes virus family, the sexually transmitted herpes simplex virus 1 (HSV-1) and 2 (HSV-2), has proven to be challenging. But now, a clinical trial, based on an HSV-2 vaccine, is being conducted. Read more...

FDA Clears IND for Lorus Blood Cancer Drug

July 28, 2014 10:53 am | News | Comments

Lorus Therapeutics Inc. announced that the FDA completed its review and cleared the company's IND application of LOR-253 for the treatment of hematologic malignancies including acute myeloid leukemia, high-risk myelodysplastic syndromes, lymphomas and multiple myeloma. Read more...

AstraZeneca, Roche Collaborate on Companion Diagnostic Test

July 28, 2014 10:41 am | News | Comments

AstraZeneca announced it has entered into collaboration with Roche to develop a plasma-based companion diagnostic test to support AZD9291, AstraZeneca’s investigational compound in clinical development for non-small-cell lung cancer (NSCLC). Read more...

COSMOS Results Published on World Hepatitis Day

July 28, 2014 10:35 am | News | Comments

Medivir AB announced that results from the phase 2 COSMOS clinical study were published in The Lancet, demonstrating that 92% of genotype 1 chronic hepatitis C virus adult patients treated with simeprevir in combination with sofosbuvir achieved sustained virologic response 12 weeks after the end of treatment. Read more...

CHMP Recommends MA for Diabetes Drug

July 25, 2014 11:24 am | News | Comments

Novo Nordisk announced that the Committee for Medicinal Products for Human Use under the European Medicines Agency adopted a positive opinion, recommending marketing authorization for Xultophy for the treatment of type 2 diabetes mellitus in adults. Read more...

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