Increasing Percentages of New Drugs are Failing Phase II and III Trials

June 1, 2011 | by

In the drug discovery pipeline, Phase I trials are first used to evaluate if a new drug is safe, then Phase II trials are done to assess the drug’s efficacy, and finally Phase III trials are performed to monitor side effects and compare the drug to similar compounds already on the market. Each consecutive phase includes more people to refine the results obtained in the previous phase. A recent analysis by the Centre for Medicines Research in the UK has concluded that since 2008, the failure rate for drugs in Phase II and III clinical trials has been rising [1-2]. Phase II success rates are currently at 18%, lower than at any other phase of drug development.

Drug development pipeline

Amid Product Recalls, J&J Looks to Restore Brand Confidence

May 11, 2011 | by

It’s spring, pollen is everywhere, and for many people, it’s allergy season. However, there’s one thing that’s missing this year: the over-the-counter (OTC) allergy medicine Benadryl. It’s just another of the many products recalled by Johnson & Johnson over the past year-and-a-half. The list of over 40 pulled products is a who’s who of common OTC medications: Tylenol, Benadryl, Motrin, Rolaids, St. Joseph and Sudafed.

Recalled Johnson & Johnson products

You Can Control Your Asthma

May 3, 2011 | by

World Asthma Day is an annual event organized by the Global Initiative for Asthma (GINA). The event raises awareness about asthma and works to improve asthma care around the world. This year’s theme is “You Can Control Your Asthma”. It aims to continue the focus on asthma control described in the latest version of the GINA guidelines [1].

World Asthma Day 2011

FDA Revamps Recall Resource, Promotes Food-Safety Awareness

April 29, 2011 | by

The United States has one of the safest food supplies in the world. Nevertheless, according to the Centers for Disease Control and Prevention (CDC), foodborne disease causes approximately 76 million illnesses, 325,000 hospitalizations and 5,000 deaths in the U.S. each year [1] — and that’s just an estimate based on data collected from the Foodborne Diseases Active Surveillance Network (FoodNet), other surveillance networks and published studies.

FDA food safety

Neural Stem Cell Therapy for Ischemic Stroke Patients

March 15, 2011 | by

The single largest cause of adult disability in the developed world is ischemic stroke, in which blood flow in or to the brain is blocked. It precipitates immense amounts of social and financial costs. Currently, therapies for stroke focus on prevention or acute phase treatments that arrest the stroke while it is happening. But many patients are not fortunate enough to get acute phase treatment and suffer neurological damage that leads to functional and cognitive impairment. Until now, there have been almost no options for such patients. But last February, a company called ReNeuron received approval to begin a clinical trial of neural stem cell therapy for disabled stroke patients [1]. Two patients have been treated thus far and the therapy appears to be safe.

Neural stem cell therapy