scholarly journals 2020 FDA TIDES (Peptides and Oligonucleotides) Harvest

2021 ◽  
Vol 14 (2) ◽  
pp. 145
Author(s):  
Othman Al Musaimi ◽  
Danah Al Shaer ◽  
Fernando Albericio ◽  
Beatriz de la Torre
Keyword(s):  
Adverse Effects ◽  
Global Health ◽  
Drug Administration ◽  
Mode Of Action ◽  
Chemical Structure ◽  
Food And Drug Administration ◽  
Health Crisis ◽  
New Drug ◽  
Target Mode ◽  
The Us

2020 has been an extremely difficult and challenging year as a result of the coronavirus disease 2019 (COVID-19) pandemic and one in which most efforts have been channeled into tackling the global health crisis. The US Food and Drug Administration (FDA) has approved 53 new drug entities, six of which fall in the peptides and oligonucleotides (TIDES) category. The number of authorizations for these kinds of drugs has been similar to that of previous years, thereby reflecting the consolidation of the TIDES market. Here, the TIDES approved in 2020 are analyzed in terms of chemical structure, medical target, mode of action, and adverse effects.

scholarly journals 2018 FDA Tides Harvest

2019 ◽  
Vol 12 (2) ◽  
pp. 52 ◽  
Author(s):  
Danah Al Shaer ◽  
Othman Al Musaimi ◽  
Fernando Albericio ◽  
Beatriz de la Torre
Keyword(s):  
United States ◽  
Drug Administration ◽  
Mode Of Action ◽  
Chemical Structure ◽  
Food And Drug Administration ◽  
The United States ◽  
New Drugs ◽  
Target Mode ◽  
United States Food ◽  
States Food

In 2018, the United States Food and Drug Administration (FDA) approved a total of 59 new drugs, three of them (5%) are TIDES (or also, -tides), two oligonucleotides and one peptide. Herein, the three TIDES approved are analyzed in terms of medical target, mode of action, chemical structure, and economics.

scholarly journals 2019 FDA TIDES (Peptides and Oligonucleotides) Harvest

2020 ◽  
Vol 13 (3) ◽  
pp. 40 ◽  
Author(s):  
Danah Al Shaer ◽  
Othman Al Musaimi ◽  
Fernando Albericio ◽  
Beatriz G. de la Torre
Keyword(s):  
Adverse Effects ◽  
Mode Of Action ◽  
Chemical Structure ◽  
Imaging Agents ◽  
Antibody Drug Conjugates ◽  
Drug Conjugates ◽  
Target Mode ◽  
Medical Indications ◽  
Antibody Drug ◽  
The Way

2019 has been an excellent year in terms of peptides and oligonucleotides (TIDES) approved by the FDA. Despite the drop in the number of total drugs approved by the FDA in 2019 in comparison with 2018 (48 vs. 59), the total number of TIDES authorized increased (seven vs. three). Year after year, TIDES are increasingly present in therapy, as imaging agents, theragnostic and constituent moieties of other complex drugs, such as antibody drug conjugates. This means a consolidation of these kinds of drugs in the pharmaceutical arena, paving the way in the coming years for the approval of others for diverse medical indications. Here the TIDES approved in 2019 are analyzed in terms of chemical structure, medical target, mode of action, and adverse effects.

The NIMH MATRICS Initiative: Development of a Consensus Cognitive Battery

2006 ◽  
Vol 2 (1) ◽  
pp. 173-186 ◽  
Author(s):  
Robert S. Kern ◽  
Michael F. Green ◽  
Stephen R. Marder
Keyword(s):  
Drug Administration ◽  
Cognitive Deficits ◽  
Food And Drug Administration ◽  
New Drugs ◽  
Step Process ◽  
New Drug ◽  
The Us ◽  
Treatment Research ◽  
Broad Consensus

ABSTRACTA key obstacle to the development of new drugs to treat the cognitive deficits of schizophrenia was the absence of a standard by which to measure their efficacy. Before granting approval for any new drug for this condition, the US Food and Drug Administration wanted a standard cognitive endpoint based on a broad consensus-based method. To address this obstacle, the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) intiative oversaw a process to develop a consensus neurocognitive battery. Its development included a ten-step process that is described in this article.

scholarly journals Public Disclosure of the Filing of New Drug and Therapeutic Biologics Applications With the US Food and Drug Administration

2019 ◽  
Vol 179 (8) ◽  
pp. 1144
Author(s):  
Harinder Singh Chahal ◽  
David Szeto ◽  
Anam H. Chaudhry ◽  
Daniel W. Sigelman ◽  
Stella Kim ◽  
...  
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Public Disclosure ◽  
New Drug ◽  
The Us ◽  
Therapeutic Biologics

scholarly journals Recent New Drug Approvals, Part 2: Drugs Undergoing Active Clinical Studies in Children

2013 ◽  
Vol 18 (1) ◽  
pp. 14-38 ◽  
Author(s):  
Rebecca F. Chhim ◽  
Chasity M. Shelton ◽  
Michael L. Christensen
Keyword(s):  
Drug Administration ◽  
Clinical Studies ◽  
Food And Drug Administration ◽  
New Drug ◽  
The Us ◽  
Drug Approvals ◽  
Approved Drugs

The objective of this 2-part review is to provide information about drugs that have been recently approved by the US Food and Drug Administration. Part 1 reviewed recently approved drugs with pediatric indications. Part 2 reviews drugs recently approved only in adults and have published or ongoing studies in children.

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