New drug development Mark Mathieu // Drug Repurposing

New drug development Mark Mathieu

Mathieu was dismissed from LSU

Data from Boston-based Paraxel International Corp. (press release), which helps drug companies develop and launch new medications, shows that in 2007 the FDA received 28 applications for the marketing of new molecular entities—i.e., drugs that include an active ingredient never before approved for sale in the U.S. That’s up 33% from 21 NME marketing applications in 2006. On the downside, only 16 NMEs were approved in 2007, a “many-year low, ” Paraxel said. Still, Paraxel’s Mark Mathieu noted that the increase in NME marketing applications is an encouraging sign for a biopharma industry struggling to bring new product through the pipeline and to market.

Writes Mathieu in Parexel’s US Drug Approval Trends and Yearbook 2008/2009: “Even as the pharmaceutical industry’s research and development pipelines swelled to all-new records once again in 2008, new drug launches, the very lifeblood of the industry, continued to languish….Clearly, 2007 did nothing to allay concerns over the dearth of new drug launches….At the same time, there are a number of encouraging signs. The pharmaceutical industry continues to hit new records for the number of drugs under development. In 2007, for example, the number of new FDA-regulated clinical trial starts jumped 11.6% to yet another record. More importantly, the databases that track the number of drugs in development have begun to see significant growth in the all-important Phase 3 clinical trial pipeline.”

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