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Daily news and top headlines for drug research professionals

iCo Posts Top-Line Phase 2 Results for Eye Disease Drug

June 9, 2014 2:50 pm | News | Comments

iCo Therapeutics Inc. announced top-line results related to the eight month visual acuity primary endpoint for subjects enrolled in the Phase 2 iDEAL Study, conducted in collaboration with JDRF, evaluating the efficacy and safety after repeated injections of iCo-007 in patients with diabetic macular edema. Read more...

FDA Grants Edison’s Leigh Syndrome Drug Orphan Status

June 9, 2014 2:35 pm | News | Comments

Edison Pharmaceuticals announced that the FDA has granted Orphan Drug status to vatiquinone for the treatment of Leigh syndrome, an inherited lethal, progressive, predominately pediatric, neuromuscular disorder for which there are no approved treatments. Read more...

Merck Kicks Off Phase 3 HIV Therapy Trial

June 6, 2014 2:44 pm | News | Comments

Merck announced that the first patient has been enrolled in the company’s global Phase 3 clinical trial, ONCEMRK, which is assessing a once-daily investigational formulation of Isentress as part of combination HIV therapy for treatment-naïve HIV-1-infected adults. Read more...

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Cubist Posts Positive Pivotal Data for Novel Antibiotic

June 6, 2014 2:30 pm | News | Comments

Cubist Pharmaceuticals Inc. announced that The Lancet Infectious Diseases published online the positive results from ESTABLISH-2, a pivotal Phase 3 clinical trial of the investigational antibiotic Sivextro, which is being developed for the treatment of acute bacterial skin and skin structure infections and complicated skin and soft tissue infections. Read more...

Vertex Posts Positive Proof-of-Concept Results for CF Drug

June 5, 2014 2:22 pm | News | Comments

Vertex Pharmaceuticals Inc. announced the results of a two-part proof-of-concept study of ivacaftor in 24 people with CF who have a residual function mutation. The first part evaluated ivacaftor in a two-week crossover design over two treatment cycles, and the second part evaluated ivacaftor in an eight-week open-label design. Read more...

Novartis Polycythemia Vera Drug Improves Disease Control

June 5, 2014 10:42 am | News | Comments

Novartis announced results from the first-ever pivotal Phase 3 study evaluating a JAK 1/2 inhibitor for the treatment of polycythemia vera (PV). Read more...                          

FDA Lifts Hold on Halozyme Pancreatic Cancer Trial

June 5, 2014 9:50 am | News | Comments

Halozyme Therapeutics announced that the FDA has removed the clinical hold on patient enrollment and dosing in the ongoing Phase 2 trial evaluating PEGPH20 in patients with pancreatic cancer, permitting the study to resume under a revised protocol. Read more...

EGFR Inhibitor Looks Promising in Lung Cancer

June 4, 2014 2:39 pm | News | Comments

Data from the ongoing Phase 1 AURA study in patients with EGFRm+, advanced NSCLC, demonstrate that the overall disease control rate was 94% for patients with EGFR T790M+ tumors - meaning that their tumors shrank or became stable - following treatment with the investigational drug AZD9291. Read more...

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Jazz Narcolepsy Drug Moving to Phase 3

June 4, 2014 10:55 am | News | Comments

Jazz Pharmaceuticals presented data from the Phase 2b study evaluating JZP-110 (formerly known as ADX-N05) as a potential new treatment for the symptoms of excessive daytime sleepiness (EDS) in adults with narcolepsy. Read more...      

Bayer Trial Will Evaluate Riociguat in New Indication

June 4, 2014 10:36 am | News | Comments

Bayer HealthCare announced the start of a randomized, double-blind, placebo-controlled Phase 2b study to investigate the efficacy and safety of riociguat in patients with symptomatic pulmonary hypertension (PH) associated with idiopathic interstitial pneumonia (IIP). Read more...

AFFiRiS Alzheimer's Drug Excels in Phase 2

June 4, 2014 10:32 am | News | Comments

AFFiRiS announced the results of a Phase 2 study of their proprietary compound AD04. Results indicate that AD04 was the first drug ever to demonstrate clinical and biomarker effects consistent with disease modification in Alzheimer's patients. Read more...

New York to Hold Clinical Trials for Marijuana

June 4, 2014 9:53 am | by Josefa Velasquez, Associated Press | News | Comments

New York state is partnering with a British company to hold clinical trials for marijuana-based medication for children who have seizures that are resistant to their medicine. Read more...                  

Array's MEK Inhibitors Advance in Phase 3, Pivotal Trials

June 3, 2014 2:18 pm | News | Comments

Two Array BioPharma-invented MEK inhibitors, binimetinib (for melanoma and ovarian cancer) and selumetinib (for neurofibromatosis type 1, plexiform neurofibromas, NSCLC, thyroid cancer, uveal melanoma), were showcased at the 50th annual meeting of the American Society of Clinical Oncology. Read more...

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Xcovery Reveals Interim Phase 1 NSCLC Results

June 3, 2014 2:01 pm | News | Comments

Xcovery presented preliminary results at the annual meeting of the ASCO from a Phase 1 study of X-396, a potent small molecule anaplastic lymphoma kinase inhibitor, that showed X-396 is well tolerated and has antitumor activity in patients with ALK positive non-small cell lung cancer. Read more...

Arena Kicks Off Study of Autoimmune Diseases Drug

June 3, 2014 1:55 pm | News | Comments

Arena Pharmaceuticals Inc. announced the initiation of dosing in an investigational Phase 1b clinical trial of APD334, a novel, oral drug candidate that targets the sphingosine 1-phosphate subtype 1 (S1P1) receptor, to evaluate the compound for the treatment of a number of autoimmune diseases. Read more...

Gilead Updates Phase 2 Results for CLL Drug

June 3, 2014 1:46 pm | News | Comments

Gilead Sciences Inc. announced updated interim results of a Phase 2 study (Study 102) evaluating GS-9973, its investigational oral inhibitor of spleen tyrosine kinase (Syk), for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL). Read more...

Public Perception of Clinical Trials Markedly Improved

June 3, 2014 1:40 pm | News | Comments

inVentiv Clinical Trial Recruitment Solutions, in collaboration with The Center for Information and Study on Clinical Research Participation, has released the results of research showing public perceptions of clinical trials has improved – good news for companies hoping to recruit for a trial. Read more...

Merck’s Melanoma Drug Ups Survival 69%

June 3, 2014 1:27 pm | News | Comments

Merck announced new data from the company’s large ongoing Phase 1b study (KEYNOTE-001) evaluating pembrolizumab (MK-3475), Merck’s investigational anti-PD-1 antibody, as a single agent (monotherapy) in 411 patients with advanced melanoma. Read more...

Cytokinetics Posts Positive Follow-Up Results for ALS Treatment

June 3, 2014 10:33 am | News | Comments

Cytokinetics Inc. announced that additional results from BENEFIT-ALS were presented during the Joint Congress of European Neurology at the International Congress Center in Istanbul, Turkey. Read more...              

Novartis Multiple Myeloma Drug Ups PFS in Phase 3

June 3, 2014 10:23 am | News | Comments

Novartis presented results from a pivotal Phase 3 trial showing a 37% improvement in PFS when using the investigational compound LBH589 (panobinostat) in combination with bortezomib and dexamethasone, compared to treatment with the same regimen with placebo, in patients with relapsed or relapsed and refractory multiple myeloma. Read more...

Personalized Cancer Therapies Come of Age

June 3, 2014 8:44 am | by Sean Harper, M.D., Executive Vice President of Research and Development, Amgen | Articles | Comments

For many decades, scientific advances in cancer treatment were characterized by a slow, non-linear progress that resulted in treatments with a less than stellar ability to target cancer cells. Now, the advent of biomarker-driven drug development and the drive toward personalized medicine have provided a new approach to the treatment of advanced cancer. Read more...

Drug Helps Breast Cancer Patients Stay Fertile

June 2, 2014 2:40 pm | by Marilynn Marchione, AP Chief Medical Writer | News | Comments

Doctors may have found a way to help young breast cancer patients avoid infertility caused by chemotherapy, by giving them a drug to shut down their ovaries temporarily to boost the odds they will work after treatment ends, and it might even improve survival, a study found. Read more...

mAb Therapy Works in Patients with Extremely High LDL

June 2, 2014 2:29 pm | News | Comments

Amgen announced new detailed data from the Phase 3 TESLA study evaluating its novel investigational cholesterol-lowering medication, evolocumab, in patients with homozygous familial hypercholesterolemia, a rare and serious genetic disorder characterized by extremely high LDL-C and premature cardiovascular disease. Read more...

Novartis Skin Cancer Drug Hits Phase 2 Primary Endpoint

June 2, 2014 2:02 pm | News | Comments

Novartis announced the results of a pivotal Phase 2 trial demonstrating that patients with locally advanced (laBCC) or metastatic basal cell carcinoma (mBCC) taking the investigational oral compound LDE225 (sonidegib) had marked and sustained tumor shrinkage after a median follow-up of 13.9 months. Read more...

Roche Drug is FDA's First Breakthrough Therapy in Bladder Cancer

June 2, 2014 11:17 am | News | Comments

Roche announced results from a Phase 1 study that showed the investigational cancer immunotherapy MPDL3280A shrank tumors of people previously treated for metastatic urothelial bladder cancer (UBC). The FDA has granted MPDL3280A Breakthrough Therapy Designation. Read more...

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