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Daily news and top headlines for drug research professionals

OptiNose Posts Positive Results for New Migraine Treatment

June 10, 2014 3:00 pm | Videos | Comments

OptiNose announced that the COMPASS trial, a head-to-head comparison of the investigational treatment AVP-825 to sumatriptan tablets, currently the most widely used prescription medication for migraine, met the primary endpoint of greater reduction in migraine pain during the first 30 minutes after treatment. Read more...

Adamas Initiates Phase 3 Trial of Parkinson's Drug

June 10, 2014 2:54 pm | News | Comments

Adamas Pharmaceuticals Inc. announced that it has initiated a pivotal Phase 3 clinical study of ADS-5102 (amantadine HCl), a high-dose, controlled-release version of amantadine for the treatment of patients with Parkinson's disease who have developed levodopa-induced dyskinesia (LID). Read more...

Achillion Kicks Off Phase 1 Trial of Hep C Drug

June 10, 2014 2:50 pm | News | Comments

Achillion Pharmaceuticals Inc. announced the company has begun dosing ACH-3422, a uridine-analog nucleotide polymerase inhibitor, for seven days in patients with genotype 1 chronic hepatitis C viral infection (HCV) in its ongoing Phase 1 clinical trial. Read more...

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ArGEN-X, LLS Partner on Antibody Trial for Cancer

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

arGEN-X announced it has entered into a partnership with The Leukemia & Lymphoma Society (LLS) in which both parties will contribute to the funding of a Phase 2 clinical study of the company’s lead candidate, ARGX-110, in patients with refractory Waldenström’s macroglobulinemia (WM). Read more...

Alkermes Initiates Phase 3 Depressive Disorder Trials

June 10, 2014 10:38 am | News | Comments

Alkermes plc announced the initiation of FORWARD-3 and FORWARD-4, two of the three planned Phase 3 core efficacy studies in the pivotal clinical program for ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of major depressive disorder. Read more...

Alzheimer's Drug Tested on Healthy Seniors with Risk Factors

June 10, 2014 10:16 am | by Lauran Neergaard, AP Medical Writer | News | Comments

In one of the most ambitious attempts yet to thwart Alzheimer's disease, a major study got underway Monday to see if an experimental drug can protect healthy seniors whose brains harbor silent signs that they're at risk. Read more...      

Isis Kicks Off Phase 1 Study of Neuromuscular Disease Drug

June 9, 2014 2:59 pm | News | Comments

Isis Pharmaceuticals Inc. announced that it has initiated a Phase 1 study for ISIS-DMPKRx, which is designed to reduce the production of toxic dystrophia myotonica-protein kinase (DMPK) RNA in cells, including muscle cells, for the treatment of Myotonic Dystrophy Type 1 (DM1). Read more...

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...

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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...

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...                          

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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...

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...

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...

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