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.

scholarly journals Analysis of randomized clinical trials leading to new drug approvals in India and USA

2016 ◽  
Vol 3 (2) ◽  
pp. 68
Author(s):  
Vihang S. Chawan ◽  
Sagar V. Badwane ◽  
Kalpesh V. Gawand ◽  
Abhishek M. Phatak ◽  
Madhura S. Naik
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
New Drugs ◽  
Institutional Review Boards ◽  
Eligibility Criteria ◽  
New Drug ◽  
Institutional Review ◽  
United States Food ◽  
The Usa ◽  
Drug Approvals

<p class="abstract"><strong><span lang="EN-US">Background:</span></strong>To analyse the number of randomized clinical trials and subsequent new drug approvals in India and USA.</p><p class="abstract"><strong>Methods:</strong> Data was collected for completed randomized clinical trials done by multinational in India and USA from www.clinicaltrials.gov during the period from 1/1/2009 to 31/08/2014 and the subsequent new drug approvals from 1/1/2010 to 31/10/2015 for India obtained from Central Drugs Standard Control Organization (CDSCO) (www.cdsco.nic.in.) website and for USA obtained from United States Food and Drug Administration (USFDA) (www.fda.gov) website. Results were measured in terms of percentage of completed randomized clinical trials for investigational medicinal products (IMP) leading to new drugs approvals in India and USA.</p><p class="abstract"><strong>Results:</strong> A total of 163 randomized clinical trials fulfilled the eligibility criteria. Regrouping them for the same sponsor and IMP resulted in a total of 93 randomized clinical trials. In India, 13 drugs (13.93%) were approved by CDSCO, whereas in USA, 35 drugs (37.62%) were approved by USFDA out of a total of 93 randomized clinical trials. High number of randomized clinical trials were conducted for cancer (17.20%) while less number of randomized clinical trials were conducted for gastrointestinal conditions (3.22%).</p><p class="abstract"><strong>Conclusions:</strong> This study revealed that, there exists a wide gap between the new drug approvals permitted by USFDA and CDSCO. Thus there is disparity in the number of clinical trials conducted and market availability of new drugs in India showing that India is lagging behind the USA in approval of new drugs. The regulatory authorities, investigators and institutional review boards should ensure the availability of new drugs in India after they have been researched in the population<span lang="EN-US">.</span></p>

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

2020: A Record Year for Drug Approvals

2021 ◽  
Vol 36 (4) ◽  
pp. 174-175
Author(s):  
Nancy L. Losben
Keyword(s):  
United States ◽  
Drug Administration ◽  
Generic Drugs ◽  
Drug Evaluation ◽  
Food And Drug Administration ◽  
The United States ◽  
New Drugs ◽  
Novel Drugs ◽  
United States Food ◽  
States Food

In 2020 The United States Food and Drug Administration?s (FDA) Center for Drug Evaluation and Research (CDER) approved 53 novel drugs, five more than in 2019, but still an aggressive number when compared with 2015 when only 45 new drugs were released to the market. CDER, the largest department within the FDA, has robustly approved a rising number of generic drugs in the last several years, increasing their accessibility and reducing patient and payor costs.

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. 

New Drugs and FDA Publicity

1983 ◽  
Vol 17 (9) ◽  
pp. 671-672
Author(s):  
Wayne L. Pines
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
New Drugs ◽  
Public Understanding ◽  
The Public ◽  
New Drug ◽  
Drug Approvals

The Food and Drug Administration (FDA) has been criticized for publicly announcing the approval of significant new drugs. This policy was formulated for two reasons: to encourage better public understanding of the benefits and limitations of new drugs and to account to the public for new drug approvals. The FDA makes such announcements only for major new drugs. This policy, which started in 1978, seems to have worked well in accomplishing the FDA's objectives.

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. 

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.

Synthesis and Biological Activity of Hydrazones and Derivatives: A Review

2020 ◽  
Vol 20 (5) ◽  
pp. 342-368 ◽  
Author(s):  
Juliana de Oliveira Carneiro Brum ◽  
Tanos Celmar Costa França ◽  
Steven R. LaPlante ◽  
José Daniel Figueroa Villar
Keyword(s):  
Biological Activity ◽  
Medicinal Chemistry ◽  
Biological Activities ◽  
New Drugs ◽  
New Drug ◽  
Cancer Inflammation

Hydrazones and their derivatives are very important compounds in medicinal chemistry due to their reported biological activity for the treatment of several diseases, like Alzheimer’s, cancer, inflammation, and leishmaniasis. However, most of the investigations on hydrazones available in literature today are directed to the synthesis of these molecules with little discussion available on their biological activities. With the purpose of bringing lights into this issue, we performed a revision of the literature and wrote this review based on some of the most current research reports of hydrazones and derivatives, making it clear that the synthesis of these molecules can lead to new drug prototypes. Our goal is to encourage more studies focused on the synthesis and evaluation of new hydrazones, as a contribution to the development of potential new drugs for the treatment of various diseases.

New Drug Approvals Vol.23(1)

2020 ◽  
Vol 23 (1) ◽  
pp. 80-82
Author(s):  
Md Akbar Hossain
Keyword(s):  
Pharmaceutical Journal ◽  
New Drug ◽  
Drug Approvals

Abstract not available Bangladesh Pharmaceutical Journal 23(1): 80-82, 2020

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