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Daily news and top headlines for drug research professionals

Tiny DNA Pyramids Enter Bacteria, Deliver Deadly Payload

July 10, 2014 12:00 pm | News | Comments

Bacterial infections usually announce themselves with pain and fever but often can be defeated with antibiotics— and then there are those that are sneaky and hard to beat. Now, scientists have built a new weapon against such pathogens in the form of tiny DNA pyramids. Read more...

Astellas Submits NDA for Life-Threatening Fungal Infection Drug

July 10, 2014 12:00 pm | News | Comments

Astellas announced it has submitted a New Drug Application to the FDA seeking approval for isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis. Read more...                 

Review: Gaps Between Approval, Safety Assessment of ADHD Drugs

July 10, 2014 12:00 pm | News | Comments

Over the last 60 years, the FDA approved 20 medications for ADHD based on clinical trials that were not designed to study their long-term efficacy and safety or to detect rare adverse events, researchers report. Read more...        

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Vaccine Achieves Simultaneous Protection Against Ricin, Anthrax

July 10, 2014 12:00 pm | News | Comments

Soligenix Inc. announced that the combination of RiVax and VeloThrax induces protective immunity to both ricin toxin and anthrax toxin exposure. Read more...                           

NIH Launches Phase 1 Trial of Novel C. Diff Drug

July 10, 2014 12:00 pm | News | Comments

The National Institute of Allergy and Infectious Diseases has launched an early-stage clinical trial of CRS3123, an investigational oral antibiotic intended to treat Clostridium difficile (C. difficile) infection. Read more...     

Ario Kicks Off Efficacy Trial of Chronic Idiopathic Cough Drug

July 9, 2014 3:14 pm | News | Comments

Ario Pharma Ltd, the biopharmaceutical company developing innovative new treatments for respiratory disease, announced that it has commenced a Phase 2a study of its oral TRPV1 antagonist, XEN-D0501, for the treatment and prevention of cough in patients with chronic idiopathic cough. Read more...

DelMar Receives Canadian Funding

July 9, 2014 3:09 pm | News | Comments

DelMar Pharmaceuticals Inc. announced that the company has been awarded a non-refundable financial contribution of up to CDN$194,000 from the National Research Council of Canada's Industrial Research Assistance Program (NRC-IRAP) to support personnel and research costs. Read more...

Dezima Extends Clinical Development of Dyslipidemia Drug

July 9, 2014 3:02 pm | News | Comments

Dezima Pharma, the biotechnology company developing innovative drugs in the field of dyslipidemia, announced the approval of a Phase 1 pilot study in subjects with isolated, elevated Lipoprotein(a) (Lp(a)), for which additional funding has been secured. Read more...

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Domainex Reports Success of COPD Drug

July 9, 2014 2:57 pm | News | Comments

Domainex Ltd, a UK-based drug discovery company developing first-in-class small-molecule inhibitors of two closely-related pro-inflammatory kinases TBK1 and IKK-epsilon announced that its lead compound has demonstrated a more potent effect in a key model of COPD than either roflumulast or a p38 inhibitor. Read more...

Arthritis Drug Misses New Indication Endpoint

July 9, 2014 2:51 pm | News | Comments

Shares of Celgene Corp. slipped in premarket trading Wednesday after the drugmaker said its psoriatic arthritis treatment Otezla missed the main goal of a late-stage study exploring an additional use in a painful spinal joint disorder called ankylosing spondylitis. Read more...

EFPIA Denounces French Law on Off-label Drug Use

July 9, 2014 2:43 pm | News | Comments

EFPIA, the European Federation of Pharmaceutical Industries and Associations, criticized the intent of the French government to broadly enlarge the use of-off label drugs for economic reasons, even if there is an approved drug available. Read more...

Baxter Snags First Drug Candidate from NIH Program

July 9, 2014 1:35 pm | News | Comments

A drug candidate developed by researchers at the NIH’s National Center for Advancing Translational Sciences (NCATS) and its collaborators to treat sickle cell disease has been acquired by Baxter International’s BioScience business. Read more...  

Governor Pushes for Trials of Marijuana Derivative

July 9, 2014 1:12 pm | by Christina A. Cassidy | News | Comments

Georgia's governor is pushing clinical trials for a marijuana-derived drug that proponents say could help treat severe seizure disorders among children. Read more...                         

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Sandoz Launches Generic Diovan in the U.S.

July 9, 2014 11:24 am | News | Comments

Sandoz announced the U.S. introduction of an authorized generic version of Diovan (valsartan) tablets for the treatment of high blood pressure (HBP) and will market the authorized generic version of Diovan in the same strengths marketed for the branded version of Diovan. Read more...

Insys Updates Timing of NDA for Dronabinol Oral Solution

July 9, 2014 11:18 am | News | Comments

Insys Therapeutics Inc. announced the successful completion of a human abuse study for Dronabinol Oral Solution, its proprietary, orally administered liquid formulation of the synthetic cannabinoid dronabinol in development for the treatment of CINV and anorexia associated with weight loss in patients with AIDS. Read more...

BI Posts Positive Results for Leukemia Drug

July 9, 2014 11:12 am | News | Comments

Results from a Phase 2 study that compared volasertib plus low-dose cytarabine (LDAC), a form of chemotherapy, versus LDAC alone in older patients with untreated acute myeloid leukemia (AML) were published in the American Society of Hematology journal Blood. Read more...

EU Antitrust Fines Drugmakers $580M

July 9, 2014 10:50 am | News | Comments

The European Union's antitrust body is imposing a fine of 428 million euros ($580 million) on France's pharmaceutical company Servier and five producers of generic medicines for distorting competition, by striking a series of deals with the producers of generic medicines to protect Perindopril from price competition. Read more...

CardioCell Launches Phase 2a Chronic Heart Failure Trial

July 8, 2014 3:19 pm | News | Comments

CardioCell LLC announced the start of its Phase 2a clinical trial for chronic heart failure (HF) patients with non-ischemic cardiomyopathy. Read more...                            

FDA Approves NovoSeven for Glanzmann's Thrombasthenia

July 8, 2014 3:12 pm | News | Comments

Novo Nordisk announced the FDA approved NovoSeven RT as the first recombinant treatment for bleeding episodes and perioperative management in patients with Glanzmann's Thrombasthenia with refractoriness to platelet transfusions, with or without antibodies to platelets. Read more...

FDA Grants Priority Review to Purdue’s Abuse-Deterrent Pain Drug

July 8, 2014 3:05 pm | News | Comments

Purdue Pharma L.P. announced that the FDA has granted Priority Review designation for the company’s once-daily, single-entity hydrocodone bitartrate tablet (HYD). Read more...                      

Nanoparticles Can Enhance Cisplatin in Chemotherapy

July 8, 2014 2:19 pm | News | Comments

Researchers have developed a new formulation of cisplatin, a common chemotherapy drug, that significantly increases the drug's ability to target and destroy cancerous cells. Read more...                   

FDA Accepts NDA for Sanofi's Basal Insulin

July 8, 2014 10:40 am | News | Comments

Sanofi announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's New Drug Application (NDA) for Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL), an investigational basal insulin, formerly abbreviated as "U300." Read more...

Japan Approves First All-Oral, Interferon- and Ribavirin-Free Hep C Treatment

July 8, 2014 10:34 am | News | Comments

Bristol-Myers Squibb announced that the Japanese Ministry of Health, Labor and Welfare has approved Daklinza, a potent, pan-genotypic NS5A replication complex inhibitor, and Sunvepra, a NS3/4A protease inhibitor, providing a new treatment that can lead to cure for many patients in Japan who currently have no treatment options. Read more...

Personalized Immunotherapy for Leukemia Named Breakthrough Therapy

July 7, 2014 2:36 pm | News | Comments

A University-developed personalized immunotherapy was awarded the FDA's Breakthrough Therapy designation for the treatment of relapsed and refractory adult and pediatric acute lymphoblastic leukemia. The therapy, known as CTL019, is the first personalized cellular therapy for the treatment of cancer to receive this classification. Read more...

NIH Awards SBIR Grant for Epigenetic Database

July 7, 2014 2:25 pm | News | Comments

Reaction Biology Corp. (RBC) announced that it has been awarded a Phase 1 SBIR grant from the National Center for Advancing Translational Sciences to create a database of epigenetic drug interactions. Read more...           

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