The Year's New Drugs & Biologics - 2009.

This annual article presents new drugs and biologics that were launched or approved for the first time during the previous year. In 2009, 51 new medicines and vaccines reached their first markets. Line extensions (new indications, new formulations and new combinations of previously marketed products) accounted for more than 30% of the new products launched in 2009. In addition to providing an overview of all drugs and biologics launched or approved for the first time ever in the previous year, this article will also review in further depth the first-in-class drugs launched for the first time last year, providing a better understanding of their novel mechanisms of action; an analysis of the discovery and development periods for the year's new products; and a comprehensive overview of drug repositioning as a strategy for extending the life spans of medicines. We also provide a brief glimpse at selected drugs and biologics which could reach their first markets in the foreseeable future.

Overcoming the obstacles in the pharma/biotech industry: 2009 update.

The research-based biopharmaceutical industry faced new challenges during 2009, many rooted in the global economic recession, which further complicated a situation that was already characterized by the obstacles traditionally debated in this and other publications: generic competition, patent expirations and accusations of declining innovation. Once again, companies have been forced to seek out new strategies (mergers, acquisitions, licensing deals, offshore clinical testing and more) in order to cut costs and fill the gaps in their R&D pipelines. However, it is conceivable that the existing R&D model has limitations that can no longer be overcome via these traditional strategies and that the time has come for an entirely new model.

Promoting, improving and accelerating the drug development and approval processes.

While pharma/biotech companies have developed their own tactics for improving R&D productivity and rounding out their pipelines, as discussed elsewhere in this issue, regulatory agencies have in recent years also begun to collaborate with the industry by creating new programs and policies designed to promote, improve and accelerate new drug development and approval. Beginning 26 years ago with the U.S. FDA's Orphan Drug Act, agencies have attempted to revitalize research especially in the areas of untreatable or undertreated disorders through fast-track development and priority review vouchers, and have created programs such as phase 0/microdosing and Quality by Design with the objective of reducing attrition.

The year's new drugs & biologics - 2008.

This annual article presents new drugs and biologics that were launched or approved for the first time during the previous year. In 2008, 31 new medicines-this figure includes both drugs and biologics for therapeutic use as well as new diagnostic agents-reached their first markets. Line extensions (new indications, new formulations and new combinations of previously marketed products) accounted for more than one-third of the new medicines launched in 2008. In addition to providing an overview of all drugs and biologics launched or approved for the first time ever in the previous year, this article will also review in further depth the first-in-class drugs launched for the first time last year, providing a better understanding of their novel mechanisms of action; an analysis of the discovery and development periods for the year's new products; and a comprehensive overview of drug repositioning as a strategy for extending the life spans of medicines. We also provide a brief glimpse at selected drugs and biologics which could reach their first markets in the foreseeable future.

Overcoming the obstacles in the pharma/biotech industry: 2008 update.

In the face of patent expirations on blockbuster drugs and declining innovation in the industry, pharma/biotech companies are restructuring their research and development operations and are pursuing an aggressive strategy of acquisitions, licensing deals and research collaborations in an attempt to fill the gaps in their product pipelines.

The year's new drugs.

Forty-one new biological drugs and diagnostic agents reached their first markets in 2005. Antiinfective therapy, immunomodulators and agents for immunization and central nervous system drugs were the most active therapeutic groups in terms of new chemical entities launched for the first time, with six market introductions apiece. The United States was again the most active market for new products, with a total of 21 new launches in 2005, constituting 50% of the total of new introductions for the year.

Executive summary: nicotine addiction.

Nicotine addiction is one of the most prevalent addictive behaviors worldwide. According to the World Health Organization (WHO), 1.3 billion men, women and children worldwide are smokers. In spite of increased awareness and action on the part of both governments and individuals, tobacco continues to be the leading cause of preventable disease and death in the United States, as well as in many other countries. According to WHO, there are nearly 5 million tobacco-related deaths worldwide each year and nearly half of the smokers in the world today will die as a result of their addiction. For individuals who are motivated to quit smoking, a combination of pharmacotherapy and behavioral therapy has been shown to be most effective in controlling the symptoms of nicotine withdrawal. Drugs marketed as smoking cessation aids include nicotine replacement therapy (NRT) and sustained-release bupropion hydrochloride. New drugs in development are directed to targets including nicotinic acetylcholine receptors, cannabinoid receptors, dopamine receptors and opioid receptors. Several therapeutic vaccines are also in the pipeline.

The year's new drugs.

Twenty-three new biological drugs and diagnostic agents reached their first markets in 2004. The oncolytic drugs therapeutic group was the most active in terms of new launches, with seven market introductions, and the United States was the most active single market for new products, with a total of 10 new launches in 2004.

The year's new drugs.

Inaugurated 16 years ago, this annual article provides the opportunity to present from both a historical and a research perspective those molecular entities and biologic drugs that were launched or approved in various countries for the first time during the past year. According to our records, 30 new chemical entities and biologic drugs and two diagnostic agents reached their first markets in 2003. Another six new products were approved for the first time in 2003 but were not launched before year-end. During the past year, Endocrine and Metabolic Drugs was the most active therapeutic group in terms of new launches, with six market introductions. The United States was again the most active market for new products, with a total of 20 new launches in 2003, constituting 66.6% of the total of new introductions for the year.

The year's new drugs.

The United States was the most active market for new product launches (22 products, 62.5%) in a year that saw 35 new chemical entities and biological drugs and two diagnostic agents reach their first markets. The most active therapeutic groups were anti-infective, oncolytic and metabolic drugs with five launches for each.

The Year's New Drugs.

Thirty-four new chemical entities and biological drugs and two diagnostic agents reached their first markets in 2001. Antiinfective Therapy was the most active therapeutic group in terms of new launches, with five market introductions, and the United States was the most active single market for new products, with a total of 15 new launches in 2001, constituting 43% of all new introductions for the year. (c) 2002 Prous Science. All rights reserved.