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New Molecular Entities |
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PAREXEL Data Indicate
U.S. Marketing Applications for New Molecular Entities Bounce
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Diabetes
Pre-Screening Vibration,
Electronic Health Records (EHRs)
PRNewswire-FirstCall
Aug 25, 2008
BOSTON, MA - New data from PAREXEL International Corporation
(NASDAQ: PRXL) , a leading global biopharmaceutical services
organization, reveal that U.S. marketing applications for new
molecular entities (NMEs) surged 33 percent in 2007. While NME
approvals reached a many-year low of 16 in the U.S., and global
new active substance (NAS) launches declined 19 percent to 25,
during 2007, marketing applications for NMEs increased to 28 in
2007, up from 21 filed in 2006, according to PAREXEL's
newly-released The US Drug Approval Trends and Yearbook
2008/2009. |
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Mark Mathieu, Director of
Publications at PAREXEL and Editor of The US Drug Approval
Trends and Yearbook 2008/2009, said: "NME and NAS approvals are
key measures of new drug productivity in the biopharmaceutical
industry, and these measures tend to improve based on the volume
of new drug submissions. The recent increase in the number of
NME submissions is an encouraging sign. NMEs are a closely
watched category because they are medicines that have never
before been approved for any use."
"Our analysis also shows that record percentages of drug
marketing applications that the FDA has designated as priority
submissions are going straight to approval in the first review
cycle," added Mr. Mathieu.
The US Drug Approval Trends and Yearbook 2008/2009 provides a
comprehensive overview of the current state of the U.S. Food and
Drug Administration (FDA) drug review and approval process, as
well as a broad range of in-depth analyses and benchmarks,
supported by hundreds of data tables, graphs, and exhibits,
including:
-- New Drug Application (NDA) and NME first-cycle success rates
and trends
-- Complete approval profiles for each NME and NDA
-- Analysis of drug review times, performance trends, and
success rates by therapeutic category, as well as standard
versus priority classification
-- The impact of accelerated approval, orphan drug status, and
related programs on review times and outcomes
-- Data regarding other key new drug submissions, including NDA
resubmissions, efficacy supplements, and manufacturing
supplements
PAREXEL's newly-released The US Drug Approval Trends and
Yearbook 2008/2009 is the largest compendium of drug approval
trends and metrics ever compiled. To order the compendium ($295
USD), visit
http://www.barnettinternational.com/EducationalServices/ or
email customerservice@barnettinternational.com. For more PAREXEL
book titles published and distributed by Barnett International,
a division of Cambridge Healthtech Institute (CHI), visit
Barnett Educational Services at
http://www.barnettinternational.com/.
About PAREXEL International
PAREXEL International Corporation is a leading global
biopharmaceutical services organization, providing a broad range
of knowledge-based contract research, medical communications and
consulting services to the worldwide pharmaceutical,
biotechnology and medical device industries. Committed to
providing solutions that expedite time-to-market and peak-market
penetration, PAREXEL has developed significant expertise across
the development and commercialization continuum, from drug
development and regulatory consulting to clinical pharmacology,
clinical trials management, medical education and reimbursement.
Perceptive Informatics, Inc., a subsidiary of PAREXEL, provides
advanced technology solutions, including medical imaging, to
facilitate the clinical development process. Headquartered near
Boston, Massachusetts, PAREXEL operates in 69 locations
throughout 52 countries around the world, and has more than
8,800 employees. For more information about PAREXEL
International visit http://www.PAREXEL.com. |
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