2012: Banner Year for New Drugs

Fueled by new cancer therapeutics, last year the annual new molecular and biological entity approval count from the U.S. Food and Drug Administration (FDA) saw its highest year since 1997. One-third of the novel products approved by the FDA’s Center for Drug Evaluation and Research (CDER) are used to treat cancers of the blood, breast, colon, prostate, skin and thyroid.

FDA approved

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

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

Daily Aspirin May Reduce Cancer Risk

It is old news that aspirin is good for your heart. But a recent report published in The Lancet, the premiere medical journal in the United Kingdom, claims that at least 75mg of aspirin every day can also reduce the risk of developing many different types of cancers.

There is already evidence that taking aspirin every day for five years can reduce the risk of colorectal cancer. Moreover, aspirin has been shown to reduce the incidence and/or growth rate of a number of cancers in animal models. To determine if aspirin can reduce the risk of other cancers in humans, Peter Rothwell and colleagues at the University of Oxford undertook a meta-analysis of eight randomized trials originally performed to study aspirin’s role in preventing vascular events. This study was independent of any commercial interests.