Aardvark released exploratory data from its stopped Phase 3 HERO trial in Prader-Willi syndrome after FDA lifted the hold, and plans a redesigned Phase 3.
|Articles|December 1, 2014
- Applied Clinical Trials-12-01-2014
- Volume 23
- Issue 12
The Cost to Develop an Approved New Drug Now Exceeds $2.5B
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Based on a recently completed analysis, the Tufts Center for the Study of Drug Development (Tufts CSDD) estimates that the cost to develop a new prescription medicine that gains marketing approval is now $2.6 billion. This figure includes $1.4 billion in direct out-of-pocket costs to develop the new prescription drug, plus the high cost of drug failures and the capitalized costs spent over a lengthy drug development cycle time.
The estimated cost to develop an approved drug in 2003 is $1.04 billion (expressed in 2013 dollars). The updated $2.6 billion cost estimate represents an 8.5% compound annual growth rate over the 2003 level. Factors that have likely contributed to this high and rising cost to develop an approved drug include larger and more complex clinical trials and declining drug development success rates.
The Price of Innovation
- Tufts CSDD
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How Mobile Technology is Evolving in Clinical Trialsalmost 12 years ago
The Future of ePRO Platformsalmost 12 years ago
Sponsors Face New Challenges in Developing Combination Drugsalmost 12 years ago
Health Challenges Mount for Europealmost 12 years ago
Clinical Document Exchange Portals: Trendy or Revolutionary?almost 12 years ago
Steps for a Successful Clinical Trial Management Systemalmost 12 years ago
DIA Opts for Paris in the Springtimealmost 12 years ago
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