Novel New Drug Approvals in 2011: A Succinct Analysis of Drug Discovery Trends in the United States

2012 ◽  
Vol 5 (2) ◽  
pp. 1661-1665
Author(s):  
D Samba Reddy
Keyword(s):  
United States ◽  
Drug Discovery ◽  
Lupus Erythematosus ◽  
Lymphoblastic Leukemia ◽  
The United States ◽  
New Drugs ◽  
Chronic Obstructive ◽  
The Past ◽  
New Drug ◽  
Drug Approvals

Thirty (30) new drugs have been approved by the FDA in 2011 for marketing in the United States. This list includes novel new drugs, known as new molecular entities (NMEs), biologics and new indications for drugs already approved. Eleven of the 30 NMEs were new drugs approved for orphan diseases, while twelve are considered first-in-class drugs with a unique new mechanism of action. During 2011, the FDA approved many unique and new drugs for chronic obstructive pulmonary disease, deep vein thrombosis, systemic lupus erythematosus (SLE), and epilepsy. In addition,  several new biologicals were approved in the past year for the treatment of macular degeneration, acute lymphoblastic leukemia, Hodgkin lymphoma, melanoma, chronic hepatitis C, and SLE. The introduction of 30 NMEs in 2011 underscores a robust success rate. It confirms that innovation is once again beginning to pay off. Analysis of drug approvals reveals a unique new trend in drug discovery in the face of stiff competition from generic products and declining revenues. In the existing climate of reduced pipeline for NMEs, the future and survival of big companies rests heavily on their unique niche products and biologics with relatively less competition from generic manufacturers. However, the competition for biosimilars is growing by the hour and therefore, crafting innovative generic biologicals is vital for generic biotech companies. Although the number of NMEs approved in the past 10 years has been declining, there is a substantial increase in R&D expenditure for drug discovery. Overall, the new drug approval list unveils unique and emerging trends in drug discovery especially in the current generics era. 

2020 New Drug Update

2020 ◽  
Vol 35 (4) ◽  
pp. 151-161
Author(s):  
Daniel A. Hussar ◽  
Laura A. Finn
Keyword(s):  
Rheumatoid Arthritis ◽  
The United States ◽  
New Drugs ◽  
Rating System ◽  
Chronic Obstructive ◽  
Medical Problems ◽  
Idiopathic Constipation ◽  
New Agents ◽  
Obstructive Pulmonary Disease ◽  
New Drug

Five new drugs for medical problems often affecting older people and marketed in the United States in 2019 have been considered in this review. The uses and most important properties of these agents are discussed, and a rating for each new drug is determined using the New Drug Comparison Rating system developed by the author (DAH). Advantages, disadvantages, and other important information regarding each new drug are identified and used as the basis for determining the rating. The drugs considered include new agents indicated for the treatment of patients with Parkinson's disease, rheumatoid arthritis, chronic obstructive pulmonary disease, osteoporosis in postmenopausal women, and chronic idiopathic constipation.

2020 New Drug Update

2020 ◽  
Vol 35 (4) ◽  
pp. 151-161
Author(s):  
Daniel A. Hussar ◽  
Laura A. Finn
Keyword(s):  
Rheumatoid Arthritis ◽  
The United States ◽  
New Drugs ◽  
Rating System ◽  
Chronic Obstructive ◽  
Medical Problems ◽  
Idiopathic Constipation ◽  
New Agents ◽  
Obstructive Pulmonary Disease ◽  
New Drug

Five new drugs for medical problems often affecting older people and marketed in the United States in 2019 have been considered in this review. The uses and most important properties of these agents are discussed, and a rating for each new drug is determined using the New Drug Comparison Rating system developed by the author (DAH). Advantages, disadvantages, and other important information regarding each new drug are identified and used as the basis for determining the rating. The drugs considered include new agents indicated for the treatment of patients with Parkinson's disease, rheumatoid arthritis, chronic obstructive pulmonary disease, osteoporosis in postmenopausal women, and chronic idiopathic constipation.

Policy Punctuations and Regulatory Drug Review

2003 ◽  
Vol 15 (2) ◽  
pp. 157-191 ◽  
Author(s):  
Stephen J. Ceccoli
Keyword(s):  
United States ◽  
The United States ◽  
New Drugs ◽  
Regulatory Review ◽  
Review Time ◽  
University Center ◽  
The Past ◽  
Percent Increase ◽  
New Chemical Entities ◽  
Drug Review

The FDA has dramatically decreased the regulatory review time for new drugs since the early 1990s. For example, according to the Tufts University Center for the Study of Drug Development (CSDD), which conducts triennial analyses of new drug approvals in the United States, the average FDA review time for approved New Chemical Entities (NCEs) decreased from 35.6 months in 1984–86 to 16.8 months in 1996–98. Thus, in a little more than a decade, the FDA has essentially cut its average review time in half. In addition to the declining review times, the agency's workload, as measured in terms of the number of drugs approved each year, also rose considerably in the 1990s. Specifically, the agency approved a total of 232 NCEs between 1993 and 1999, compared to just 163 approvals during the previous seven-year span—a 42 percent increase. Figures 1 and 2 illustrate the agency's decreased review times and increased workload, respectively. Thus, over the past decade the FDA has approved more drugs and done so in less time than at any other period in history. Simply stated, this change in regulatory performance, especially the declining review times, has been absolutely stunning.

The Effect of Price on Pharmaceutical R&D

2009 ◽  
Vol 9 (1) ◽  
Author(s):  
Abdulkadir Civan ◽  
Michael T. Maloney
Keyword(s):  
United States ◽  
Drug Development ◽  
Price Elasticity ◽  
The United States ◽  
Mortality Rates ◽  
New Drugs ◽  
New Drug ◽  
Development Pipeline ◽  
New Drug Development

Abstract This work extends prior research that finds drug development is driven by demand factors such as mortality rates of the diseases new drugs are aimed at. Here we find that the number of drugs in the development pipeline is strongly positively related to the price of existing drugs treating those diseases. This gives us a direct price elasticity measure from which we can draw some inference about the effect on new drug development that might occur if the pricing regime in the United States were to change.

scholarly journals Drug Discovery over the Past Thirty Years: Why Aren’t There More New Drugs?

2016 ◽  
Vol 29 (1) ◽  
pp. 61
Author(s):  
Lloyd Fricker
Keyword(s):  
Drug Discovery ◽  
Translational Research ◽  
Basic Science ◽  
Science Studies ◽  
Disease Process ◽  
Science Research ◽  
The United States ◽  
New Drugs ◽  
Biomedical Knowledge ◽  
The Past

The rate of drug discovery has not kept pace with the exponential increase in biomedical knowledge. For the past 30 years, the number of new molecular enti- ties approved by the United States Food and Drug Administration has averaged 20 to 30 drugs per year, except for a peak in the mid-1990s that briefly doubled this rate. This modest productivity cannot be explained by lack of funding, as the research budgets of government and industry-funded programs have increased threefold to fivefold over the past three decades. Various arguments have been proposed to account for the relative lack of innovative new drugs, but little consideration has been given to the focus on hypothesis-driven translational research. In theory, the emphasis on translational research should have led to an increase in the number of new drugs. However, in considering the historical perspective of drug discovery and the role of serendipity, it can be argued that the emphasis on translational research diverts scientists from pursuing basic-science studies that give rise to fundamental discoveries. In many cases, retro-translational research (from clinic to basic science) is necessary before the disease process can be understood well enough for scientists to develop therapeutics. Ultimately, a balance of disease-oriented and basic-science research on fundamental processes is optimal. 

scholarly journals Drug Discovery over the Past Thirty Years: Why Aren’t There More New Drugs?

2016 ◽  
Vol 29 (1) ◽  
pp. 61 ◽  
Author(s):  
Lloyd Fricker
Keyword(s):  
Drug Discovery ◽  
Translational Research ◽  
Basic Science ◽  
Science Studies ◽  
Disease Process ◽  
Science Research ◽  
The United States ◽  
New Drugs ◽  
Biomedical Knowledge ◽  
The Past

The rate of drug discovery has not kept pace with the exponential increase in biomedical knowledge. For the past 30 years, the number of new molecular enti- ties approved by the United States Food and Drug Administration has averaged 20 to 30 drugs per year, except for a peak in the mid-1990s that briefly doubled this rate. This modest productivity cannot be explained by lack of funding, as the research budgets of government and industry-funded programs have increased threefold to fivefold over the past three decades. Various arguments have been proposed to account for the relative lack of innovative new drugs, but little consideration has been given to the focus on hypothesis-driven translational research. In theory, the emphasis on translational research should have led to an increase in the number of new drugs. However, in considering the historical perspective of drug discovery and the role of serendipity, it can be argued that the emphasis on translational research diverts scientists from pursuing basic-science studies that give rise to fundamental discoveries. In many cases, retro-translational research (from clinic to basic science) is necessary before the disease process can be understood well enough for scientists to develop therapeutics. Ultimately, a balance of disease-oriented and basic-science research on fundamental processes is optimal.

International Research and Variation in Views of Ethnicity

2012 ◽  
Vol 2 (2) ◽  
pp. 66-72
Author(s):  
Ella Inglebret ◽  
Amy Skinder-Meredith ◽  
Shana Bailey ◽  
Carla Jones ◽  
Ashley France
Keyword(s):  
United States ◽  
Classification System ◽  
International Research ◽  
The United States ◽  
Research Articles ◽  
Journal Articles ◽  
Research Participants ◽  
The Past ◽  
International Scale ◽  
Publication Patterns

The authors in this article first identify the extent to which research articles published in three American Speech-Language-Hearing Association (ASHA) journals included participants, age birth to 18 years, from international backgrounds (i.e., residence outside of the United States), and go on to describe associated publication patterns over the past 12 years. These patterns then provide a context for examining variation in the conceptualization of ethnicity on an international scale. Further, the authors examine terminology and categories used by 11 countries where research participants resided. Each country uses a unique classification system. Thus, it can be expected that descriptions of the ethnic characteristics of international participants involved in research published in ASHA journal articles will widely vary.

Proportion of Individuals With Past-Year Suicidal Ideation Who Attempted Suicide Over the Past 10 Years in the United States, and the Influence of Age and Sex

Crisis ◽  
2020 ◽  
pp. 1-5
Author(s):  
Shannon Lange ◽  
Courtney Bagge ◽  
Charlotte Probst ◽  
Jürgen Rehm
Keyword(s):  
United States ◽  
Suicidal Ideation ◽  
Random Effects ◽  
Attempted Suicide ◽  
Suicide Attempts ◽  
The United States ◽  
Individual Level ◽  
The Past ◽  
Meta Analyses ◽  
Age Category

Abstract. Background: In recent years, the rate of death by suicide has been increasing disproportionately among females and young adults in the United States. Presumably this trend has been mirrored by the proportion of individuals with suicidal ideation who attempted suicide. Aim: We aimed to investigate whether the proportion of individuals in the United States with suicidal ideation who attempted suicide differed by age and/or sex, and whether this proportion has increased over time. Method: Individual-level data from the National Survey on Drug Use and Health (NSDUH), 2008–2017, were used to estimate the year-, age category-, and sex-specific proportion of individuals with past-year suicidal ideation who attempted suicide. We then determined whether this proportion differed by age category, sex, and across years using random-effects meta-regression. Overall, age category- and sex-specific proportions across survey years were estimated using random-effects meta-analyses. Results: Although the proportion was found to be significantly higher among females and those aged 18–25 years, it had not significantly increased over the past 10 years. Limitations: Data were self-reported and restricted to past-year suicidal ideation and suicide attempts. Conclusion: The increase in the death by suicide rate in the United States over the past 10 years was not mirrored by the proportion of individuals with past-year suicidal ideation who attempted suicide during this period.

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