The Novel Drugs of 2014 –Record Approvals for Niche Markets

2015 ◽  
Vol 8 (3) ◽  
pp. 2889-2893
Author(s):  
D Samba Reddy
Keyword(s):  
Prescription Drugs ◽  
New Drugs ◽  
The Novel ◽  
Niche Markets ◽  
Novel Drugs ◽  
Accelerated Approval ◽  
Pricing Power ◽  
Drug Approvals ◽  
Unique Mechanism ◽  
The U.S

In 2014, 41 new drugs were approved by the FDA, the highest approval in two decades. This number was 52% higher than the 27 approvals in 2013, indicating another year of excellent innovation and productivity. Seventeen drugs (41%) were First-in-Class with a new or unique mechanism of action for treating a disease. Moreover, 17 of 41 (41%) of these novel drugs were for the treatment of rare diseases, a testament to continued focus or shift to niche diseases. The U.S. FDA is the leading authority for drug approvals worldwide. Many schemes and tracks at the FDA have led to accelerated approval of novel drugs. Such reviews as fasttrack or breakthrough designation are established for meeting demand more quickly. Despite such historic drug approvals, there is continued productivity crisis in R & D due to steady cost escalation for drug discovery and development. The U.S. pharmaceutical market is forecasted to increase from an estimated value of $395 billion in 2014 to reach $548 billion by 2020. The prices appear to be increasing faster for branded prescription drugs. Overall, the current drug approvals and trends clearly reveal the pharma industry shift to niche diseases for pricing power and return on investment.   

The Novel Drugs of 2015 – An Extraordinary Growth of Innovative Pharmaceuticals

2016 ◽  
Vol 9 (4) ◽  
pp. 3331-3336
Author(s):  
D. Samba Reddy ◽  
Savitha Reddy
Keyword(s):  
Rare Diseases ◽  
Prescription Drugs ◽  
Orphan Drugs ◽  
Pharmaceutical Products ◽  
New Drugs ◽  
Regulatory Review ◽  
Regulatory Pathways ◽  
Novel Drugs ◽  
Drug Approvals ◽  
Tract Infections

The FDA has approved 45 new drugs in 2015, a record approval in two decades, indicating another year of excellent innovation and productivity. There are many regulatory pathways at the FDA for the approval of novel drugs. Sixteen drugs (36%) were First-in-Class with a new or unique mechanism of action for treating a disease. About 29% of the new drugs are biologics. Moreover, 21 of 45 (47%) are orphan drugs for the treatment of rare diseases. The FDA approved many new drugs to treat various forms of cancer, urinary tract infections, chronic hepatitis C, cystic fibrosis, irritable bowel syndrome, heart failure, and high cholesterol, as well as the first approved reversal agent for a commonly-used blood thinner.  For the second consecutive year, the FDA approved more “orphan” drugs for rare diseases than any previous year in recent history. From 2006 through 2014, the FDA averaged about 28 novel drug approvals per year. Such products represent innovation and provide important new therapies for patients worldwide. Despite such record new drug approvals, there is a continued productivity crisis in R&D due to a progressive rise in cost for drug discovery and development. The U.S. pharmaceutical market is forecasted to reach $548 billion by 2020. The prices appear to be increasing faster for generic and branded prescription drugs. Overall, faster development and regulatory review contributed to a spike in record approval of innovative pharmaceutical products in 2015

Novel Drugs and Biologics of 2016: A Boom for Neurodrugs in the Pipelin

2017 ◽  
Vol 10 (5) ◽  
pp. 3809-3814
Author(s):  
D Samba Reddy
Keyword(s):  
Muscular Atrophy ◽  
Clinical Care ◽  
New Drugs ◽  
Essential Medicines ◽  
High Demand ◽  
The Past ◽  
Novel Drugs ◽  
Innovative Products ◽  
Cns Drugs ◽  
The U.S

This article provides a brief overview of novel drugs approved by the U.S. FDA in 2016.  It also focuses on the emerging boom in the development of neurodrugs for central nervous system (CNS) disorders. These new drugs are innovative products that often help advance clinical care worldwide, and in 2016, twenty-two such drugs were approved by the FDA. The list includes the first new drug for disorders such as spinal muscular atrophy, Duchenne muscular dystrophy or hallucinations and delusions of Parkinson’s disease, among several others. Notably, nine of twenty-two (40%) were novel CNS drugs, indicating the industry shifting to neurodrugs. Neurodrugs are the top selling pharmaceuticals worldwide, especially in America and Europe. Therapeutic neurodrugs have proven their significance many times in the past few decades, and the CNS drug portfolio represents some of the most valuable agents in the current pipeline. Many neuroproducts are vital or essential medicines in the current therapeutic armamentarium, including dozens of “blockbuster drugs” (drugs with $1 billion sales potential).  These drugs include antidepressants, antimigraine medications, and anti-epilepsy medications. The rise in neurodrugs’ sales is predominantly due to increased diagnoses of CNS conditions. The boom for neuromedicines is evident from the recent rise in investment, production, and introduction of new CNS drugs.  There are many promising neurodrugs still in the pipeline, which are developed based on the validated “mechanism-based” strategy. Overall, disease-modifying neurodrugs that can prevent or cure serious diseases, such as multiple sclerosis, epilepsy, and Alzheimer’s disease, are in high demand. 

Safety-Related Postmarketing Modifications of Drugs for Hematological Malignancies

2019 ◽  
Vol 143 (1) ◽  
pp. 73-77
Author(s):  
Anat Gafter-Gvili ◽  
Ariadna Tibau ◽  
Pia Raanani ◽  
Daniel Shepshelovich
Keyword(s):  
Hematological Malignancies ◽  
New Drugs ◽  
Priority Review ◽  
Regulatory Review ◽  
Regulatory Pathways ◽  
The Us ◽  
Black Box Warnings ◽  
Accelerated Approval ◽  
Drug Approvals ◽  
Approved Drugs

The prevalence of safety-related postmarketing label modifications of medications for hematological malignancies is unknown. We identified 35 new drugs indicated for hematological malignancies approved by the US Food and Drug Administration between January 1999 and December 2014. Characteristics of supporting trials and safety-related label modifications from approval to December 2017 were collected from drug labels. Regulatory review and approval pathways were also collected. New drug approvals were supported by trials with a median of 167 patients (interquartile range 115–316). All drugs were approved based on surrogate endpoints. Twenty-seven drug approvals (77%) were not supported by randomized controlled trials. All drugs received orphan drug designation, and most were granted fast track designation, priority review, and accelerated approval (83, 74, and 60%, respectively). A total of 28 drugs (80%) had postmarketing safety-related label modifications. Additions to black box warnings, contraindications, warnings and precautions, and common adverse reactions were identified in 31, 11, 77, and 46% of drugs, respectively. Five drugs (14%) were permanently or temporarily withdrawn from the US market. Drugs for hematological malignancies are often approved based on limited evidence through expedited regulatory pathways with incomplete safety profiles. Hematologists should be vigilant for unrecognized side effects when prescribing newly approved drugs.

scholarly journals Analysis of FDA Novel Drug Approvals

2021 ◽  
Vol 14 (1) ◽  
pp. 225-233
Author(s):  
Ajay Kumar Shukla ◽  
Kumar Shukla ◽  
Rekha Mehani ◽  
Swati Jain ◽  
Sheema Maqsood
Keyword(s):  
The Novel ◽  
Medical Needs ◽  
Novel Drugs ◽  
The Us ◽  
Innovative Products ◽  
United States Food ◽  
High Predictability ◽  
States Food ◽  
Drug Approvals ◽  
Novel Drug

Background: United States Food and Drug Administration (FDA) is the fastest drug review agency in the world. FDA is responsible for the protection of public health by assuring that foods are safe, wholesome, sanitary and, properly labeled. Novel drug Approvals are usually innovative products to serve unmet medical needs or otherwise help to advance patient care. Methods: FDA novel drug approvals were analyzed from calendar year (CY) 2012 to 2018 based on not only their numbers but also BASED ON their impact, innovation, access, and predictability. Results: The total number of novel drugs approved from CY 2012 to 2018 was 279 (average 40 novel drugs/ year). Impact of novel drug approvals: 50% were first in class and 43% were for rare diseases. Overall expedited development and review methods were used in 63% of the novel drug approvals. Access of novel drug approvals: 84% were first-cycle approval, 74% were approved in the US before other countries, 58% priority reviews among novel drug approvals. Predictability of novel drug approvals: 98% approvals able to meet PDUFA goal dates for application review. Conclusions: Novel drug approvals during CY 2012-2018 had a high quality which is very much evident by their high impact, good access, and high predictability.

Insights into the FDA 2018 new drug approvals.

2019 ◽  
Vol 16 ◽  
Author(s):  
Alaa Bedair ◽  
Fotouh R. Mansour
Keyword(s):  
Drug Evaluation ◽  
Drug Market ◽  
New Drugs ◽  
Good News ◽  
Antimicrobial Drugs ◽  
New Drug ◽  
Novel Drugs ◽  
The Usa ◽  
Drug Approvals ◽  
Online Library

Objective: The center of drug evaluation and research (CDER) in the food and drug administration (FDA) approves new drugs every year. This review discusses the novel drugs of the FDA in 2018 with emphasis on the breakthrough drugs, the milestones in the approved list, and drugs with the highest expected sales in 2024. Method: The following scientific search engines were surveyed for the clinical trials of the drugs approved by FDA in 2018: Pubmed, Springer link, ScienceDirect, Scopus, Wiley online library, Taylor and Francis, and Google Scholar. The total forecast sales were compared based on information from Cortellis database, EvaluatePharma, and Nature Biobusiness Briefs. Results: The 2018 year was full of good news for the drug market in the USA, with 59 new drug approvals by FDA, which is the highest number of approvals in the last twenty years. The oncology and the antimicrobial drugs represent almost 50% of the new list, which gives hope to cancer patients and subjects with infectious diseases. In the 2018 FDA list, a number of drugs are expected to exceed 1$ billion dollars of sales by 2024. Conclusion: The new drugs approved by FDA in 2018 have been reviewed. This year showed the highest number of new drug approvals in the last two decades. Among the 59 drugs approved in 2018, 14 drugs are considered breakthrough which revives hope for many poorly managed diseases. The list also contains 19 drugs that are first in class and 43 that were given priority reviews.

Herbal Medicine: Clinical Perspective & Regulatory Status

2020 ◽  
Vol 23 ◽  
Author(s):  
Md Abul Barkat ◽  
Anjali Goyal ◽  
Harshita Abul Barkat ◽  
Mohammad Salauddin ◽  
Faheem Hyder Pottoo ◽  
...  
Keyword(s):  
Herbal Medicine ◽  
Herbal Medicines ◽  
New Drugs ◽  
Herbal Drugs ◽  
Clinical Perspective ◽  
Regulatory Status ◽  
Novel Drugs ◽  
History Of ◽  
Pros And Cons ◽  
Health Complications

Abstract:: Herbal medicines pays an important in treating the vaious diseases mainly due to the their potentially high therapeutic values and also due to the better acceptance of vaioruspatient under different health complications. The herbal medicine practice involves use of part of plant, entire plant or the selectctive isolated phytomedicineand the use and practices based on these has its pros and cons and has been greatly affected during the dawn. The search of new drugs during scientific era revives the interest in discovery of herbal drugs from different natural resources during 20th century. The present modern healthcare system invovlves utilization drugs and 50% of them are of ofnaural origin. Herbal drug disocovery found to be highly costly affair with low success rate and it hinders the further progress in utilizting the phytomedicine in treating the various deseases. But in recent years there is an increase in the search interest of herbal drugs mainly by the pharmaceutical industry and those invoves in the search of novel drugs from the herbs. Discovery of such new novel phytomedicines has to overcomes various challenges in indentification of active extracts and their toxicity, advereffects, herb drug interaction and importantly their regulatory requirments. The present review mainly focused on the history of herbal medicine, current clinical perspective, pharmaceutical, and regulatory challenges as well as its clinical presentation. Moreover, problems encountered in drug discovery from herbal resources and its possible solutions are delineated.

scholarly journals Belonging in the Coronaverse: Will There Be Time?

2021 ◽  
Vol 1 (1) ◽  
pp. 100-115
Author(s):  
Kate Fischer ◽  
Malika Rakhmonova ◽  
Mike Tran
Keyword(s):  
College Experience ◽  
The United States ◽  
Limited Time ◽  
The Novel ◽  
Residential University ◽  
To Come ◽  
Novel Coronavirus ◽  
University Experience ◽  
The U.S ◽  
Older Siblings

Abstract Since the spring of 2020 SARS-CoV-2, the novel coronavirus, has upended lives and caused a rethinking of nearly all social behaviors in the United States. This paper examines the ways in which the pandemic, shutdown, and gradual move towards “normal” have laid bare and obfuscated societal pressures regarding running out of time as it pertains to the residential university experience. Promised by movies, television, and older siblings and friends as a limited-time offer, the “typical” college experience is baked into the U.S. imaginary, reinforcing a host of notions of who “belongs” on campus along lines of race, class, and age. Fed a vision of what their whole lives “should be”, students who enter a residential four-year college are already imbued with a nostalgia for what is yet to come, hailed, in Althusser’s (2006[1977]) sense, as university subjects even before their first class. The upheaval of that subjecthood during the pandemic has raised important questions about the purpose of the college experience as well as how to belong to a place that is no longer there.

Fake Pharmaceuticals: How They and Relevant Legislation or Lack Thereof Contribute to Consistently High and Increasing Drug Prices

2003 ◽  
Vol 29 (4) ◽  
pp. 525-542
Author(s):  
Merri C. Moken
Keyword(s):  
United States ◽  
Prescription Drugs ◽  
The United States ◽  
Pharmaceutical Products ◽  
New Drugs ◽  
Pharmaceutical Companies ◽  
Brand Name ◽  
Potential Factors ◽  
Counterfeit Pharmaceuticals ◽  
New Applications

The use of pharmaceutical products in the United States has increased more than the use of any other health resource from 1960 to 1990. In excess of 9,600 drugs were on the market in 1984, and the Food and Drug Administration (“FDA”) approves approximately 30 new drugs and countless new applications for alterations of already existing drugs each year. In 2001, the $300 billion pharmaceutical industry sold $154 billion worth of prescription drugs in the United States alone, nearly doubling its $78.9 billion in sales in 1997. With such a rapid increase in market domination and expenditures, the U.S. government and many hospitals have focused their attention on the sales and pricing practices of pharmaceutical companies, as well as other potential factors contributing to these escalating prices. One such cause of the steadily increasing prices of brand name pharmaceuticals is the sale of fake or counterfeit pharmaceuticals (also called “look-alike” drugs).

Feminismo, traduccióón cultural y traicióón en Malinche de Laura Esquivel

2010 ◽  
Vol 26 (1) ◽  
pp. 111-127 ◽  
Author(s):  
Ricardo F. Vivancos Péérez
Keyword(s):  
Visual Representations ◽  
Laura Esquivel ◽  
Cultural Translation ◽  
The Novel ◽  
The U.S

This essay explores the complexity of Laura Esquivel's conciliatory approach to the figure of Malinche in her novel Malinche (2006). I read the text in relation to textual and visual representations by Mexican and Chicana feminists. I also analyze the first three editions of the novel in the U.S. and in Mexico. As a result, I analyze symbolic betrayals that have to do with processes of cultural translation. In this context, I discuss the function of Esquivel as a writer in-between cultures who has the authority to design the plot and to be a traitor, but may also be betrayed in the process.

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