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Daily news and top headlines for drug research professionals

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...

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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...

Paradigm Kicks Off Genomic Profiling for Cancer Registry

August 5, 2014 2:16 pm | News | Comments

Paradigm has announced they have initiated genomic testing for Pharmatech's AccessPPM Cancer Registry, which is designed to collect EMR data and genomic information to help best match cancer patients with targeted clinical trials. Read more... 

Scientists Use Subcellular Imaging to Visualize Glutamate Receptors

August 5, 2014 2:08 pm | News | Comments

Scientists at the National Institutes of Health have created high-resolution images of the glutamate receptor, a protein that plays a key role in nerve signaling. The advance, published online in the journal Nature, opens a new window to study protein interactions in cell membranes in exquisite detail. 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...

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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...

Glioblastoma Triple Therapy Revs Up Immune System

August 5, 2014 10:52 am | News | Comments

A triple therapy for glioblastoma, including two types of immunotherapy and targeted radiation, has significantly prolonged the survival of mice with these brain cancers, according to a new report by scientists at the Johns Hopkins Kimmel Cancer Center. 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...

Global Research Team Advances Insulin Therapy

August 5, 2014 10:41 am | News | Comments

Since its landmark discovery in 1922, insulin has improved the health and extended the lives of more than 500 million people worldwide with diabetes mellitus, yet the question of how this key hormone binds to its target cells in the body’s organs has posed an enduring scientific mystery. Read more...

US Gov’t, Military Spotted Ebola Drug

August 5, 2014 10:35 am | by Marilynn Marchione, AP Chief Medical Writer | News | Comments

Two American aid workers infected with Ebola are getting an experimental drug so novel it has never been tested for safety in humans and was only identified as a potential treatment earlier this year, thanks to a longstanding research program by the U.S. government and the military. Read more...

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BMS, Allied Minds Form Unique Research Enterprise

August 4, 2014 2:52 pm | News | Comments

Allied Minds and Bristol-Myers Squibb Co. announced the formation of Allied-Bristol Life Sciences LLC, a new jointly owned enterprise created to identify and foster research and pre-clinical development of biopharmaceutical innovations from leading university research institutions across the United States. 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...           

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...       

NIH's Fauci Says Ebola Vaccine Not Far Away

August 4, 2014 1:40 pm | News | Comments

The nation's top infectious disease official says there's hope that a vaccine against Ebola will be available as early as next July. Dr. Anthony Fauci of the National Institutes of Health says such a preventive vaccine has been successfully tested with monkeys. Read more...

Medivir Licenses RSV Drug Program from BI

August 4, 2014 10:42 am | News | Comments

Medivir AB announced that it has entered a license agreement with Boehringer Ingelheim International GmbH for exclusive, global rights to a drug program for the treatment and prevention of Respiratory Syncytial Virus (RSV) infection. 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...

FDA Approves Lilly, BI Diabetes Drug

August 4, 2014 10:20 am | News | Comments

Federal regulators have approved a new treatment from U.S. drugmaker Eli Lilly and Co. and its German counterpart, Boehringer Ingelheim, for the most common form of diabetes, type 2, which accounts for more than 90% of the diabetes cases diagnosed in the United States. Read more...

EMA, FDA Grant Glioblastoma Drug Orphan Drug Designation

August 4, 2014 10:12 am | News | Comments

AbbVie announced the EMA and the FDA have granted orphan drug designation to AbbVie's investigational compound ABT-414, an anti-epidermal growth factor receptor antibody drug conjugate, which is being evaluated for safety and efficacy in patients with glioblastoma multiforme. Read more...

Capsaicin May Inhibit Gut Tumors

August 4, 2014 10:06 am | News | Comments

Researchers at the University of California, San Diego School of Medicine report that dietary capsaicin – the active ingredient in chili peppers – produces chronic activation of a receptor on cells lining the intestines of mice, triggering a reaction that ultimately reduces the risk of colorectal tumors. Read more...

Sirona Biochem Synthesizes New Anti-Inflammatory

July 31, 2014 2:28 pm | News | Comments

Sirona Biochem Corp. announced the achievement of the first batch of compound in the joint venture with Bloom Burton & Co. Compounds developed within the framework of the joint venture (JV) will be entering development in the areas of rare inflammatory and infectious diseases. Read more...

BGI Buys Genome Mapping System

July 31, 2014 2:21 pm | News | Comments

BioNano Genomics announced the purchase of an Irys System by BGI, the world's largest genomics organization. BGI selected BioNano's platform to enable comprehensive exploration of human structural variation and to provide vastly improved assemblies for various organisms of interest, including those where no reference exists. Read more...

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