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Daily news and top headlines for drug research professionals

Tonix Pharmaceuticals Launches Phase 3 Study in Fibromyalgia

May 15, 2015 12:53 pm | News | Comments

Tonix Pharmaceuticals Holding Corp. announced that it has begun a Phase 3 clinical study of TNX-102 SL (cyclobenzaprine HCl sublingual tablet, 2.8 mg) in fibromyalgia, having recently randomized the first patient. The study is expected to enroll approximately 500 patients with fibromyalgia at approximately 35 clinical centers in the U.S. Read more...

Cancer Institute of NJ Investigates Promising Immunotherapy for Toughest Lung Cancers

May 14, 2015 11:47 am | by Seth Augenstein, Digital Reporter | Articles | Comments

Small-cell lung cancer, often caused by smoking, is among the most stubborn diseases in oncology. While it might respond initially to chemotherapy, it often recurs – and comes back even more resistant to treatment. But a new use of a known immunotherapy, bolstering the body’s immune system, is showing some promise against this disease, according to research taking place at the Rutgers Cancer Institute of New Jersey. Read more...

Roche Announces Phase 2 Study Results for Lung Cancer Immunotherapy

May 14, 2015 9:04 am | News | Comments

Roche announced interim results from a global, randomized Phase 2 study in people with previously treated NSCLC.  Read more...

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Early Data Release Ends Obesity Drug Study

May 13, 2015 12:50 pm | by Stephanie Guzowski, Editor | News | Comments

A safety study of obesity drug Contrave has been terminated after Orexigen Therapeutics released early, misleading trial data, say researchers. Takeda Pharmaceutical is seeking to end its collaboration with Orexigen. Read more...

University Admits Missteps In Second Drug Study

May 11, 2015 11:50 am | by Associated Press | News | Comments

The University of Minnesota is apologizing to a Rosemount man who claimed he was coerced into enrolling in a schizophrenia drug trial, a second local case to raise questions about patient safeguards during research. Read more...

Disrupting Cancer Pathway Could Enhance New Immunotherapies

May 11, 2015 11:26 am | by University of Chicago Medical Center | News | Comments

Understanding how to overrule a signaling pathway that can cause treatments to fail in metastatic melanoma patients should help physicians extend the benefits of recently approved immunity-boosting drugs known as checkpoint inhibitors to more patients. Read more..

Trial to Study Whether Statins Reduce Stroke, Heart Attacks in HIV Patients

May 11, 2015 10:43 am | by Washington University in St. Louis | News | Comments

The Washington University AIDS Clinical Trials Unit is the first in the nation to open a clinical trial evaluating whether statins reduce heart attacks and strokes in patients with human immunodeficiency virus (HIV). Read more....

Large Numbers of Trial Results Go Unreported; WHO Says “Report Them”

May 8, 2015 8:39 am | by Cynthia Fox, Science Editor | Articles | Comments

The World Health Organization (WHO) announced what many feel is a strong, long-overdue statement condemning parties who do not report results of clinical trials in a timely way. By one account, more than 30 percent of industry and academic groups in the U.S. have not reported results of their clinical trials for 60 months, plus. The WHO outlined specific, and strict, solutions. Read more...

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Statin Drugs Can Delay Prostate Cancer Progression in Patients, Study Shows

May 7, 2015 11:25 am | by Dana-Farber Cancer Institute | News | Comments

​Men who went on cholesterol-lowering statin drugs when they began androgen deprivation therapy for prostate cancer had a longer time in which their disease was under control than did men who didn't take statins, a clinical trial led by Dana-Farber Cancer Institute investigators shows. Read more...

Stem Cells Safe to Treat Post-Stroke Brains, Study Says

May 6, 2015 11:17 am | by Seth Augenstein, Digital Reporter | Articles | Comments

​Stem cells can be safely infused to the brain through the carotid artery after a stroke, according to new research presented by a group of doctors and researchers. Read more...

Trial of New Skin Cancer Drug Begins as First Patient Receives Treatment

May 5, 2015 3:43 pm | by University of Manchester | News | Comments

A patient has become the first to receive a new resistance-busting experimental skin cancer drug with the launch of a phase 1 clinical trial. Read more...

Hepatitis C Therapy Clears Virus in 93% of Patients in BMS-Funded Trial

May 5, 2015 11:11 am | by Stephanie Guzowski, Editor | Articles | Comments

Bristol-Myers Squibb is trying its hand at its own combination of drugs — daclatasvir, asunaprevir, and beclabuvir. A 12-week dose of the investigational three-drug hepatitis C combination cleared the virus in 93 percent with liver cirrhosis who hadn’t previously been treated, finds a study, published today in The Journal of the American Medical Association (JAMA). Read more...

Multiple Types of Resistance to New Lung Cancer Drug Identified

May 4, 2015 12:09 pm | by Dana-Farber Cancer Institute | News | Comments

After identifying three different types of resistance to a promising investigational lung cancer drug in a phase 1 trial, a team of researchers led by Dana-Farber Cancer Institute scientists say new targeted inhibitors and combinations are urgently needed to stay ahead of tumors' constant and varied molecular shape-shifting. Read more...

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Apple's ResearchKit - The Real Impact on Clinical Trials

May 1, 2015 11:57 am | by Merrilyn Datta, Ph.D., President and General Manager, Definiens | Articles | Comments

Apple recently released news about its new ResearchKit, a medical platform that intends to turn the iPhone and HealthKit into diagnostic tools. The technology, which enables researchers to create apps that gather new types of health data from users who opt-in, has gotten quite a bit of attention throughout the healthcare and technology communities. Read more...

Bayer's Contraception Safe, Effective: 5-Year Follow-Up Study

May 1, 2015 11:42 am | News | Comments

Bayer HealthCare announced today that a study published online this week in The Journal of Minimally Invasive Gynecology reinforces findings from previous clinical studies that support the effectiveness and safety of the Essure inserts and procedure for hysteroscopic sterilization, or permanent birth control. Read more...

The Prospect of Drugs to Treat Gluten Sensitivity

April 30, 2015 1:31 pm | by Stephanie Guzowski, Editor | News | Comments

Pharmaceutical companies are working to develop treatments as a first line of defense against gluten-sensitive symptoms — including abdominal pain, bloating, diarrhea, headaches and fatigue. Read more...

3 Ways Technology is Changing the Face of Drug Discovery & Development

April 29, 2015 9:04 am | by Merrilyn Datta, PhD, President and General Manager, Definiens | Articles | Comments

While personalized medicine has been a goal for some time, there have been several obstacles. Although there has been an explosion in genomic data, the corresponding clinical utility for this data has been slow to be validated. Read more...

Novartis Announces Phase 3 Study of CLL Drug Met Primary Endpoint

April 28, 2015 4:34 pm | News | Comments

The safety profile observed in this trial is consistent with other trials of Arzerra and no new safety signals were observed. Read more....

GSK Shingles Vaccine Demonstrates 97.2% Efficacy in Phase 3 Study

April 28, 2015 8:37 am | News | Comments

GlaxoSmithKline presented detailed data from a randomized phase 3 study of its investigational vaccine candidate for the prevention of shingles. Read more...

MedDay Reports Positive Phase 3 Results from MS Drug Study

April 27, 2015 8:37 am | News | Comments

The study demonstrated evidence of the efficacy and safety of MD1003, a highly-concentrated pharmaceutical-grade biotin administered at a dose of 300 mg per day in the treatment of primary and secondary progressive multiple sclerosis, a major area of unmet medical need. Read more....

Bristol-Myers Gets Positive EMA Opinion for Immunotherapy Drug, Opdivo

April 24, 2015 12:36 pm | by Stephanie Guzowski, Editor | Articles | Comments

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval of Bristol-Myers Squibb’s Opdivo today for the treatment of melanoma. Read more..

Human Clinical Trials Planned for New Anti-Cancer Compound

April 23, 2015 8:55 am | by University of Auckland | News | Comments

Researchers developed a new anti-cancer compound that will advance to human phase two clinical trials. Read more...

AACR 2015: Pembrolizumab Comes Out on Top for Melanoma, Lung Cancer

April 22, 2015 10:33 am | by Stephanie Guzowski, Editor | Articles | Comments

At the AACR Annual Meeting 2015, immunotherapies, called PD-1 inhibitors, were front and center stage, due to clinical trial results that led to U.S. Food and Drug Administration (FDA) approvals for treating melanoma and non-small cell lung cancer (NSCLC). Read more..

GW Pharmaceuticals Initiates Second Phase 3 Trial for Epidiolex

April 21, 2015 3:15 pm | News | Comments

This drug is intended for the treatment of Dravet syndrome. Read more...

Isarna Initiates First-in-Human Phase I Trial for Drug to Treat Advanced Glaucoma

April 17, 2015 8:11 am | News | Comments

The trial will enroll approximately 24 - 30 patients. Read more...

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