All NewsBio/Pharma News
All PublicationsPharmTechPharmTech Europe
MarketplaceICH Q9 Revision: A Comprehensive Resource on Quality Risk ManagementPeer-Reviewed ResearchPharmTech ProductsPharma InsightsSponsored PodcastsSponsored VideosSponsored eBooksWhitepapers
Webcasts
All VideosAsk the ExpertBehind The HeadlinesBuy, Sell, HoldDrug Digest VideosDrug Solutions PodcastPeer ExchangeSexy ScienceTech Talk
Conference CoverageConference ListingEvents
Subscribe
AnalyticsAnalyticsAnalytics
Data and Artificial Intelligence
Dosage FormsDosage FormsDosage FormsDosage FormsDosage Forms
Drug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug Development
ManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturing
OutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcing
Quality SystemsQuality SystemsQuality SystemsQuality Systems
Spotlight -
  • Analytics
  • Dosage Forms
  • Drug Development
  • Manufacturing
  • Outsourcing
  • Quality Systems
IS1
  • Applied Clinical Trials

  • BioPharm International

  • Cannabis Science and Technology

  • Chromatography Online

  • Nutritional Outlook

  • Pharmaceutical Commerce

  • Pharmaceutical Executive

  • Pharm Tech

  • Spectroscopy Online

  • Turbo Machinery Magazine

AnalyticsAnalyticsAnalytics
Data and Artificial Intelligence
Dosage FormsDosage FormsDosage FormsDosage FormsDosage Forms
Drug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug Development
ManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturing
OutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcing
Quality SystemsQuality SystemsQuality SystemsQuality Systems
IS1
  • Applied Clinical Trials

  • BioPharm International

  • Cannabis Science and Technology

  • Chromatography Online

  • Nutritional Outlook

  • Pharmaceutical Commerce

  • Pharmaceutical Executive

  • Pharm Tech

  • Spectroscopy Online

  • Turbo Machinery Magazine

    • Webcasts
    • Subscribe
Advertisement

News

Article

October 2, 2008

Pharmaceutical Technology

Pharmaceutical Technology-10-02-2008
Volume32
Issue 10

Trends: NAS Launches and NME Approvals Rise and Fall

A recent report shows a decline in NASs and a rise in NME applications in 2007.

Companies launched 25 new active substances (NAS) in 2007, a decline of 19% from the previous year, according to an August report from Parexel International. The consulting firm's US Drug Approval Trends and Yearbook 2008–2009 also reveals that only 16 new molecular entities (NMEs) were approved in the US during 2007. Yet the number of US-marketing applications filed for NMEs rose to 28 in 2007, a 33% increase from 2006.

(SHAKIROV/GETTY IMAGES)

"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," said Mark Mathieu, director of publications at Parexel, in a press release. He called the recent increase in the number of NME submissions an encouraging sign.

In the press release, Mathieu also said Parexel's analysis shows that "record percentages of drug-marketing applications that the US Food and Drug Administration has designated as priority submissions are going straight to approval in the first review cycle."

Among the NMEs that FDA approved in 2007 were Novartis's (Basel) hypertension drug "Tekturna," GlaxoSmithKline's (London) breast-cancer treatment "Tykerb," and Merck's (Whitehouse Station, NJ) HIV treatment "Isentress."

Articles in this issue

i1-557185-1408660516248.jpg
Putting Together the Pieces
Integration the Easy Way
i1-557193-1408660480210.jpg
A Case for Developing a Standards-Based Approach to Plug-and-Play Equipment
i12_t-557187-1408660506342.gif
Effect of Binder Type and Binder Level on the Properties of Agglomerates Containing Lactose and Dibasic Calcium Phosphate Dihydrate
i15-557190-1408660491177.jpg
EC Reviews: An Executive Country Review on Turkey
i8_t-557196-1408660460889.jpg
Continuous Mixing of Solid Dosage Forms via Hot-Melt Extrusion
i4-558006-1408659272985.jpg
Trends: NAS Launches and NME Approvals Rise and Fall
i3_t-557197-1408660456649.jpg
To-Do List for 2009
i1-557180-1408660535457.jpg
Complex Science
i1-557192-1408660484782.jpg
Pharma Capsules
Review of Changes in Topical Drug Product Classification
Human After All
i1-557186-1408660511909.jpg
Outsourcing Strategies of Emerging Pharma
i2-557184-1408660521788.gif
FDA Proposes Flexible Oversight for Quality Systems
i4-558009-1408659270613.jpg
Report From: Europe

Newsletter

Get the essential updates shaping the future of pharma manufacturing and compliance—subscribe today to Pharmaceutical Technology and never miss a breakthrough.

Subscribe Now!
Related Videos
A global supply chain map, visualizing the complex network of transportation routes and distribution centers | Image Credit: © venusvi - stock.adobe.com
Shortcut from point A to point B | Image Credit: © Olivier Le Moal - stock.adobe.com
Behind the Headlines, Episode 21: Waters-BD Merger, Merck’s $10B Bet, and Biotech’s Investment Frontiers
Wooden blocks spelling TARIFFS are placed on a map of North America, specifically over the United States and Mexico | Image Credit: © Rokas - stock.adobe.com
Jason Waite, International Trade Expert, Alston & Bird
Simona Guidi, Associate Director, ProPharma
Tore Bergsteiner
Behind the Headlines, Episode 20: CAR-T Milestones, Abbvie and Eli Lilly M&A Moves, and More
Related Content
Advertisement
White House | Image Credit: © Zack Frank - stock.adobe.com
August 1st 2025

Trump Sends Letters to 17 Leading Pharma Companies Outlining Most-Favored-Nation Drug Pricing Protocol

Patrick Lavery
If action is not taken within 60 days, the White House said it would “deploy every tool in our arsenal” to improve drug pricing practices for American patients.
Drug Solutions Podcast: Growth and Advancements in Fill/Finish
August 1st 2025

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Felicity Thomas
In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.
Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com
August 1st 2025

FDA Changes Opioid Pain Medication Labeling Requirements

Susan Haigney
The changes, required for safety labeling of all opioid drugs, will emphasize the risks with long-term use to combat misuse and addiction.
Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail
August 1st 2025

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Felicity Thomas
In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.
Resignation concept in a professional office setting | Image Credit: © Jane Kelly - stock.adobe.com
August 1st 2025

FDA Shake-Up: Vinay Prasad Exits Amid Tumult in Biologics Oversight

Christopher Cole
Prasad’s short FDA tenure brought stricter review standards for gene and COVID vaccines, sparking biotech concern and political backlash.
Silver Spring, MD, USA - June 25, 2022: Closeup of the FDA sign seen at its headquarters campus in Silver Spring, Maryland. FDA is a federal agency of the Department of Health and Human Services. | Image Credit: © Tada Images - stock.adobe.com
August 1st 2025

3 Reasons FDA Says Quality Investments Are Essential for Drug Manufacturers and Patients

Patrick Lavery
FDA’s latest whitepaper shows how scalable quality management investments in pharma reduce costs, improve reliability, and help prevent drug shortages.
Related Content
Advertisement
White House | Image Credit: © Zack Frank - stock.adobe.com
August 1st 2025

Trump Sends Letters to 17 Leading Pharma Companies Outlining Most-Favored-Nation Drug Pricing Protocol

Patrick Lavery
If action is not taken within 60 days, the White House said it would “deploy every tool in our arsenal” to improve drug pricing practices for American patients.
Drug Solutions Podcast: Growth and Advancements in Fill/Finish
August 1st 2025

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Felicity Thomas
In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.
Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com
August 1st 2025

FDA Changes Opioid Pain Medication Labeling Requirements

Susan Haigney
The changes, required for safety labeling of all opioid drugs, will emphasize the risks with long-term use to combat misuse and addiction.
Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail
August 1st 2025

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Felicity Thomas
In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.
Resignation concept in a professional office setting | Image Credit: © Jane Kelly - stock.adobe.com
August 1st 2025

FDA Shake-Up: Vinay Prasad Exits Amid Tumult in Biologics Oversight

Christopher Cole
Prasad’s short FDA tenure brought stricter review standards for gene and COVID vaccines, sparking biotech concern and political backlash.
Silver Spring, MD, USA - June 25, 2022: Closeup of the FDA sign seen at its headquarters campus in Silver Spring, Maryland. FDA is a federal agency of the Department of Health and Human Services. | Image Credit: © Tada Images - stock.adobe.com
August 1st 2025

3 Reasons FDA Says Quality Investments Are Essential for Drug Manufacturers and Patients

Patrick Lavery
FDA’s latest whitepaper shows how scalable quality management investments in pharma reduce costs, improve reliability, and help prevent drug shortages.
About Us
Advertise
Contact Us
Editorial Info
Editorial Advisory Board
Do Not Sell My Personal Information
Privacy Policy
Terms and Conditions
Contact Info

2 Commerce Drive
Cranbury, NJ 08512

609-716-7777

© 2025 MJH Life Sciences

All rights reserved.