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Daily news and top headlines for drug research professionals

EMA Accepts Application for New Pneumococcal Vaccine Indication

August 8, 2014 10:41 am | News | Comments

Pfizer Inc. announced that the European Medicines Agency has accepted Pfizer’s application seeking to expand the indication for Prevenar 13 in adults to include the prevention of pneumonia caused by the 13 pneumococcal serotypes contained in the vaccine. Read more...

FDA Lifts Hold on Tekmira’s Experimental Ebola Drug

August 8, 2014 9:55 am | by Matthew Perrone, AP Health Writer | News | Comments

U.S. health authorities have eased safety restrictions on an experimental drug to treat Ebola, a move that could clear the way for its use in patients infected with the deadly virus, prompting praise by Tekmira's CEO Mark Murray on Thursday. Read more...

FDA Approves Orbactiv to Treat Skin Infections

August 7, 2014 1:00 pm | News | Comments

The FDA approved Orbactiv (oritavancin), a new antibacterial drug to treat adults with skin infections, including Staphylococcus aureus, various Streptococcus species and Enterococcus faecalis. Read more...         

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Ethical Issue: Who Gets Experimental Ebola Drug?

August 7, 2014 1:00 pm | News | Comments

The use of an experimental drug to treat two Americans diagnosed with Ebola is raising ethical questions about who gets first access to unproven new therapies for the deadly disease. Read more...                

Mylan Profit Drops 30% in Q2

August 7, 2014 1:00 pm | News | Comments

Mylan Inc. on Thursday reported profit that declined by 30 percent in its second quarter, and missed analysts' expectations. The Canonsburg, Pennsylvania-based company said net income fell to $125.2 million. Read more...       

Cure to Lung Cancer May Depend on Your DNA

August 7, 2014 1:00 pm | News | Comments

The Northside Hospital Cancer Institute announced its participation in a unique National Cancer Institute clinical collaboration to treat lung cancer based on a person’s genetic makeup. Read more...               

Study Correlates Immune Response, Improved Survival in Prostate Cancer

August 7, 2014 10:58 am | News | Comments

Generex Biotechnology Corp. announced publication of a follow-up study from a Phase 1 clinical trial of the immunotherapeutic agent AE37 in patients with prostate cancer that demonstrates an association between a specific immune response generated by AE37 and improved overall survival. Read more...

Last Patient Completes Oramed Oral Insulin Trial

August 7, 2014 10:52 am | News | Comments

Oramed Pharmaceuticals Inc. reported that the last patient has completed treatment in its Phase 2a clinical trial of ORMD-0801, the company's proprietary oral insulin capsule, to treat type 1 diabetes, and top-line data is expected to be reported in the fourth quarter of 2014. Read more...

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Daiichi Sankyo, Charleston Labs Collaborate on Pain Meds

August 7, 2014 10:47 am | News | Comments

Daiichi Sankyo and Charleston Laboratories Inc. announced that the parties have entered into a strategic collaboration for the development and U.S. commercialization of novel hydrocodone combination products, including CL-108, being studied for the treatment of acute pain as well as the reduction of Opioid-Induced Nausea and Vomiting. Read more...

Health Canada Approves Abraxane, Gemcitabine for Pancreatic Cancer

August 7, 2014 10:39 am | News | Comments

Health Canada has approved Abraxane for Injectable Suspension (paclitaxel powder for injectable suspension) (nanoparticle, albumin-bound [nab] paclitaxel) for first-line treatment of adult patients with metastatic pancreatic cancer. Read more...

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...  

Cubist Recalls Some Cubicin Lots

August 6, 2014 3:25 pm | News | Comments

Cubist announced it is voluntarily recalling certain lots of Cubicin (daptomycin for injection) to the user level due to the potential presence of glass particulate matter in vials produced by a contract manufacturer. Read more...       

Year-round Preventive Meds Reduce Malaria Risk in Young Children

August 6, 2014 3:20 pm | News | Comments

A year-round preventive drug treatment substantially reduces young children’s risk of contracting malaria and poses no serious risk of adverse events, according to a study. Read more...                   

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Aspirin Cuts Risk of Digestive Tract Cancers

August 6, 2014 3:07 pm | News | Comments

New research reveals that taking aspirin can significantly reduce the risk of developing– and dying from– the major cancers of the digestive tract, i.e. bowel, stomach and esophageal cancer. 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...

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...

C. Difficile Prophylactic Program Remains on Track

August 5, 2014 3:01 pm | News | Comments

Synthetic Biologics Inc., a developer of novel anti-infective biologic and drug candidates targeting specific pathogens that cause serious infections and diseases, announced that, with a new multi-service agreement in place, the company is on track to initiate Phase 1a and 1b clinical trials of SYN-004 for the prevention of Clostridium difficile. Read more...

Nanoscale Thin-Film Technique Promises Long-Term Drug Delivery

August 5, 2014 2:50 pm | by Peter Dizikes, MIT News Office | News | Comments

About one in four older adults suffers from chronic pain. Many of those people take medication, usually as pills. But this is not an ideal way of treating pain: Patients must take medicine frequently, and can suffer side effects, since the contents of pills spread through the bloodstream to the whole body. Read more...

IPF Drug Receives Orphan Drug Designation

August 5, 2014 2:38 pm | News | Comments

Genoa Pharmaceuticals, the leader in inhaled medicines for pulmonary fibrosis, announced the U.S. Food and Drug Administration has granted orphan-drug designation to Genoa for the use of pirfenidone in their lead program - inhaled GP-101 for the treatment of idiopathic pulmonary fibrosis (IPF). 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...

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...           

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