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Optimizing Safety Surveillance During Clinical Trials Using Data Visualization Tools

October 6, 2015 | by Laura McKain, M.D., Medical Director, Pharmacovigilance; Tammy Jackson, Director, Preclarus Development, Clinical Innovation; Cindy Elko-Simms, M.D., Vice President, Pharmacovigilance, of PPD | Articles | Comments

Pharmaceutical companies must continuously monitor the safety of investigational products in development for adverse events that may be unexpected, occur at an increased frequency or severity, or result in an unexpected outcome. Ongoing safety signal detection leads to optimal patient protection and is essential to obtaining regulatory approval. Read more...

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DDD Update

Daily news and top headlines for drug research professionals

New Test Predicts Teens’ Future Risk of Heart Disease

October 6, 2015 12:18 pm | by UVA Health System | News | Comments

Risk for cardiovascular disease, currently running rampant in the United States, can now be predicted for adolescents thanks to a new diagnostic test developed by a University of Virginia Children’s Hospital pediatrician and his collaborators. Read more...


Predicting Change in the Alzheimer’s Brain

October 6, 2015 11:15 am | by MIT News Office | News | Comments

MIT researchers are developing a computer system that uses genetic, demographic, and clinical data to help predict the effects of disease on brain anatomy. Read more...


Inspirion Receives FDA Approval for MorphaBond, an Opioid Analgesic

October 6, 2015 11:09 am | News | Comments

Inspirion Delivery Technologies LLC ("Inspirion") announced that the United States Food and Drug Administration (FDA) has approved MorphaBond (morphine sulfate) extended-release tablets, for oral use, CII. Read more...


Mixed-Up Cell Transportation Key Piece of ALS, Dementia Puzzle

October 6, 2015 8:00 am | by University of Toronto | News | Comments

Researchers from the University of Toronto are one step closer to solving this incredibly complex puzzle, offering hope for treatment. Read more...


FDA Approves Alcon's Pre-loaded Intraocular Lens Delivery System

October 6, 2015 7:45 am | News | Comments

The device treats patients about to undergo cataract surgery. Read more...


Allergan, Humana Announce Research Partnership to Improve Health Outcomes

October 6, 2015 7:35 am | News | Comments

One of the collaboration's first projects focuses on Alzheimer's patients' caregiver burden. Read more...


Dengue Epidemics Linked to High Temps During Strong El Nino Season

October 6, 2015 7:30 am | by University of Pittsburgh | News | Comments

Dengue virus is transmitted by mosquitoes in the tropics and subtropics. Read more...


Cancer Test Predicts Treatment Outcomes

October 6, 2015 7:20 am | by University of Queensland | News | Comments

Researchers have announced a new tool in the fight against cancer. Read more...


NIH Establishes 4D Nucleome Research Centers and Organizational Hub at UC San Diego

October 5, 2015 11:19 am | by UC San Diego | News | Comments

Under its new 4D Nucleome Program, the National Institutes of Health (NIH) Common Fund has awarded three grants totaling more than $30 million over five years to multidisciplinary teams of researchers at University of California, San Diego. Read more...


Spark Therapeutics' Gene Therapy Shows Promising Trial Results

October 5, 2015 11:09 am | by Ryan Bushey, Associate Editor | News | Comments

Spark plans on filing for a biologics license application next year with the Food and Drug Administration. Read more...


FDA Approves Merck's Keytruda for Non-Small Cell Lung Cancer

October 5, 2015 10:15 am | News | Comments

Merck announced that the FDA has approved Keytruda (pembrolizumab) monotherapy, the company’s anti-PD-1 (programmed death receptor-1) therapy, at a dose of 2 mg/kg every three weeks, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test and who have disease progression on or after platinum-containing chemotherapy. Read more...


Stimulant Meds Safe, Effective for Children with ADHD, Congenital Heart Disease

October 5, 2015 10:07 am | by Cincinnati Children's Hospital Medical Center | News | Comments

A new study finds that children with congenital heart disease and ADHD can take stimulant medications without fear of significant cardiovascular side effects. Read more....


The Pharmaceutical Ethics of Stunning Drug-price Increases

October 5, 2015 9:59 am | by Arizona State University | News | Comments

Offering some perspective on the responsibility of pharmaceutical companies and the changes needed in the health-care system is Dr. Victor Trastek, a former vice president of Mayo Clinic and CEO of Mayo Clinic in Arizona, and now director of the School for the Science of Health Care Delivery within ASU’s College of Health Solutions. Read more...


3 Share Nobel Medicine Prize for New Tools to Kill Parasites

October 5, 2015 9:50 am | by Karl Rittermalin Rising, Associated Press | News | Comments

Three scientists from the U.S., Japan and China won the Nobel Prize in medicine on Monday for discovering drugs to fight malaria and other tropical diseases that affect hundreds of millions of people every year. Read more...


Canada Tries to Cut Soliris Price, Gets Sued by Alexion

October 5, 2015 8:00 am | by Ryan Bushey, Associate Editor | News | Comments

Soliris is an orphan drug that treats two rare blood diseases. Read more...



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