Pancreatic Cancer Drug Demcizumab Receives Orphan Drug Designation

2014 ◽  
Vol 36 (11) ◽  
pp. 21
Author(s):  
&NA;
2016 ◽  
Vol 15 (6) ◽  
pp. 440-441 ◽  
Author(s):  
Segundo Mariz ◽  
James H. Reese ◽  
Kerstin Westermark ◽  
Lesley Greene ◽  
Takahiro Goto ◽  
...  

2019 ◽  
Vol 7 (3) ◽  
pp. 1-7
Author(s):  
Christina Nicolodi

The European legislative framework on orphan medicinal products was implemented to stimulate the development of medicinal products against rare diseases and to ensure the patient’s adequate access to qualitative and specific treatment methods. Between 2000 and 2018 3210 orphan drug designation applications were submitted in Europe of which 2121 orphan designations have been issued by the European Commission. (1) Though the definitions for orphan medicinal products and the regulatory procedures are well defined, a high degree of regulatory knowledge is needed and strategic decisions on the development program must be considered at a very early stage of development: in fact, only 164 of the 2121 designated orphan development products have resulted in authorised orphan medicinal products since the orphan legislation was implemented. In this article, the requirements and procedures for the orphan designation application and maintenance at the time of marketing authorisation application are discussed in the context of the European Regulation.


Nutrients ◽  
2019 ◽  
Vol 11 (4) ◽  
pp. 709 ◽  
Author(s):  
Concetta Panebianco ◽  
Annacandida Villani ◽  
Valerio Pazienza

Cancer initiation and protection mainly derives from a systemic metabolic environment regulated by dietary patterns. Less is known about the impact of nutritional interventions in people with a diagnosis of cancer. The aim of our study was to investigate the effect of a diet rich in resistant starch (RS) on cell pathways modulation and metabolomic phenotype in pancreatic cancer xenograft mice. RNA-Seq experiments on tumor tissue showed that 25 genes resulted in dysregulated pancreatic cancer in mice fed with an RS diet, as compared to those fed with control diet. Moreover, in these two different mice groups, six serum metabolites were deregulated as detected by LC–MS analysis. A bioinformatic prediction analysis showed the involvement of the differentially expressed genes on insulin receptor signaling, circadian rhythm signaling, and cancer drug resistance among the three top canonical pathways, whilst cell death and survival, gene expression, and neurological disease were among the three top disease and biological functions. These findings shed light on the genomic and metabolic phenotype, contributing to the knowledge of the mechanisms through which RS may act as a potential supportive approach for enhancing the efficacy of existing cancer treatments.


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