Delays in New Drug Applications and Associated Factors for Orphan Anticancer Drugs in Japan Compared with the USA

2018 ◽  
Vol 32 (6) ◽  
pp. 403-412
Author(s):  
Hiroki Nakayama ◽  
Naoki Matsumaru ◽  
Katsura Tsukamoto
2020 ◽  
Vol 16 (2) ◽  
pp. 190-195 ◽  
Author(s):  
Süleyman Ediz ◽  
Murat Cancan

Background: Reckoning molecular topological indices of drug structures gives the data about the underlying topology of these drug structures. Novel anticancer drugs have been leading by researchers to produce ideal drugs. Materials and Methods: Pharmacological properties of these new drug agents explored by utilizing simulation strategies. Topological indices additionally have been utilized to research pharmacological properties of some drug structures. Novel alkylating agents based anticancer drug candidates and ve-degree molecular topological indices have been introduced recently. Results and Conclusion: In this study we calculate ve-degree atom-bond connectivity, harmonic, geometric-arithmetic and sum-connectivity molecular topological indices for the newly defined alkylating agents based dual-target anticancer drug candidates.


PLoS ONE ◽  
2017 ◽  
Vol 12 (3) ◽  
pp. e0172351 ◽  
Author(s):  
Felipe Ades ◽  
Christelle Senterre ◽  
Dimitrios Zardavas ◽  
Evandro de Azambuja ◽  
Razvan Popescu ◽  
...  

2015 ◽  
Author(s):  
Domenico Fuoco

Despite the increasing availability of chemicals, the number of New Drug Approvals (NDA) from the Food and Drug Administration (FDA) remains unchanged. The number of chemical structures available online via web-based open source applications will reach the symbolic 1 billion in the 10 next years. However, for no apparent reasons, the number of NDA accepted yearly has not changed in the past 25 years. One of the emerging paradigms of Big Pharma is that the more we know about molecular mechanisms and cell signaling pathways, the less we understand how to use this knowledge to make New Chemical Entities (NCE). Moreover, the annual number of pharmaceutical patents collected in the OCSE database has virtually not increased. Unexpectedly, the number of patents originating in the USA is decreasing significantly, while Asia is doing very well. The comparison between the number of NCEs and the American investment in Research and Development (R&D) in the last 35 years shows that to obtain a new drug blockbuster, the total investment is quasi 4 USD billion. One of the peculiarities is the inverse relationship between the investment in R&D and the continued shortfall in productivity. A main reason for this decline is that the quality of scientific reasoning done by experienced chemists is too often replaced by Big Data . It is time to change the role of chemistry in Big Pharma and to re-position it as the central science to progress and to lead to much needed innovation.


Cancer ◽  
2007 ◽  
Vol 109 (12) ◽  
pp. 2541-2546 ◽  
Author(s):  
Akiko Hori ◽  
Taro Shibata ◽  
Masahiro Kami ◽  
Eiji Kusumi ◽  
Hiroto Narimatsu ◽  
...  

Author(s):  
Thomas Heinbockel ◽  
Antonei Csoka

Drug addiction affects a large extent of young people and disadvantaged populations. Drugs of abuse impede brain circuits or affect the functionality of brain circuits and interfere with bodily functions. Cannabinoids (Δ9-tetrahydrocannabinol) form key constituents of marijuana derived from the cannabis plant. Marijuana is a frequently used illegal drug in the USA. Here, we review the effects of cannabinoids at the epigenetic level and the potential role of these epigenetic effects in health and disease. Epigenetics is the study of alterations in gene expression that are transmitted across generations and take place without an alteration in DNA sequence, but are due to modulation of chromatin associated factors by environmental effects. Epigenetics is now known to offer an extra mechanism of control over transcription and how genes are expressed. Insights from research at the genetic and epigenetic level potentially provide venues that allow the translation of the biology of abused drugs to new means of how to treat marijuana substance use disorder or other addictions using pharmacotherapeutic tools.


Author(s):  
Weilan WANG ◽  
Bingkun XIAO ◽  
Ziqi LIU ◽  
Dongxiao WANG ◽  
Man ZHU

Background: To survey the prevalence of potential drug-drug interactions (DDIs) between anticancer drugs and non-anticancer drugs and evaluate the risk factors associated with these drug-drug interactions in China. Methods: All discharged patients in the Department of Oncology were collected from Jun to Dec in 2016 with the Hospital Information System of the Chinese people’s Liberation Army General Hospital. Drugs were screened for interactions by Micromedex solutions database. Descriptive statistics were generated and logistic regression was used to identify the associated factors. Results: Among 6578 eligible patients, 1979 potential drug interactions were found in 1830 patients (27.82%). The most common drug-drug interaction was cisplatin and furosemide. Erlotinib was most likely to interact with various non-anticancer drugs. Most interactions were classified as pharmacodynamics (71.60%), major severity (97.02%) and were supported by fair documentation evidence (86.21%). In multivariate analysis, increasing number of medications, lung cancer and patients with stage IV had a higher risk for potential drug-drug interactions. Conclusion: Potential drug-drug interactions between antineoplastic drugs and non-antineoplastic drugs occur frequently in cancer patients of Chinese hospitals. Doctors should fully consider potential risk associated with DDIs. Further research should be performed to evaluate real clinical significance of these drug-drug interactions.


2018 ◽  
Vol 72 ◽  
pp. 1018-1031 ◽  
Author(s):  
Katarzyna Lipska ◽  
Agata A. Filip ◽  
Anna Gumieniczek

Inhibitors of histone deacetylases (HDIs), by affecting the process of histone acetylation, lead to changes in chromatin condensation, and in consequence, to changes in the expression of numerous genes responsible for the cell cycle and differentiation. Therefore, they can be effective in the treatment of cancer. The antitumor activity for over 15 HDIs has been confirmed so far, and some of them have been approved in the USA and Europe, mainly in combination with cytostatics or radiotherapy. For several HDIs, large clinical trials are being carried out to estimate their effectiveness, in monotherapy and new combinations. Other synthetic and natural compounds with HDI activity are tested in preclinical studies. HDIs differ in terms of chemical structure, biological activity and specificity in relation to individual HDACs. The compounds active against classic HDACs (Zn2+-dependent metalloproteins) are usually characterized by the presence the Zn2+ binding group, the linker part and the capping group. Taking into account the type of Zn2+ binding group, classic HDIs are classified as short-chain fatty acids, hydroxamic acids, cyclic peptides and benzamides. In turn, the nicotinamide adenine dinucleotide-dependent SIRTs inhibitors are small molecules, mostly nicotinamide and β-naphthol derivatives. The presented paper summarizes the most important information regarding the use of HDIs as anticancer drugs, regarding their diversified chemical structure, activity against HDACs, additional therapeutic properties and side effects. The review was made taking into account the literature from the last five years (2013-2017).


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