Gastrointestinal Featured Articles

1. NEWS ROUNDUP: Pharma Invests In Patients, More Trials Use FitBit Trackers 4/15/2016

   Clinical Leader news roundup for the week of April 11, 2016, with articles on pharma’s investment in patients, FitBit activity trackers in clinical trials, new Hep C combination treatment tested in Malaysia and Thailand, prostate and pancreatic cancer trials, the need for clinical trial participants, and making the most of clinical trial data.

2. Allergan’s Open Science Business Model Leads To Successful IBS Study 3/17/2016

   In January 2016, The New England Journal of Medicine published the results of a pivotal Phase 3 study of VIBERZI (eluxadoline), a treatment for adults suffering from irritable bowel syndrome (IBS) with diarrhea. The results were from two randomized, multicenter and multinational double-blind, placebo-controlled trials.

3. Can You Guess What This Trial Is Using To Fight Obesity? 1/12/2016

   A promising new diet may work wonders for helping individuals lose weight and fight obesity. The trial will involve taking fecal matter from the digestive tracts of healthy and thin humans, which would then be freeze-dried and put in a pill. Individuals in the study would then ingest the pills. The research does have some validity. Researchers at the Massachusetts General Hospital in Boston have discovered the microbes in digestive tracts of healthy individuals are different from those in obese individuals.

4. How Do I Get My Compound Into Phase I? 4/2/2014

   The primary challenge for pharmaceutical and biotechnology companies in developing their drugs is to carefully assess the relationship between efficacy and toxicity prior to entering into human clinical trials. By Dr. Scott E. Boley and Greg Ruppert

5. Will Protagonist Be The Hero In Making Stable Oral Peptides To Replace Injectables? 1/6/2014

   Protagonist Therapeutics has created a technology for making stable oral peptides capable of replacing injectable-only drugs and is developing entirely new oral-peptide therapeutics  or GI patients. Its initial development areas are irritable bowel diseases (IBD) and irritable bowel syndrome (IBS). Two compounds, one an injectable peptide to block IL-6, and another, an oral peptide to block integrins, will enter clinical trials in 2015.

6. Can Rapid Mobile Diagnostics Speed Up Clinical Trials And Regulatory Reviews? 8/30/2012

   As a new technological space containing all the alternatives, the most practical and immediate application for Rapid Mobile Diagnostics (RMDx) may be in clinical trials.

7. Janet Woodcock — CDER, Safety, And The Cutting Edge 9/29/2011

   Safety and innovation have become the twin poles of a dynamic struggle that both embattles and empowers the FDA’s Center for Drug Evaluation and Research (CDER). By Wayne Koberstein