2021
DOI: 10.3390/ph14020145
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2020 FDA TIDES (Peptides and Oligonucleotides) Harvest

Abstract: 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 marke… Show more

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Cited by 59 publications
(60 citation statements)
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“…Among them, 68 Ga-PSMA-11 has been approved by the American Food and Drug Administration. 21 Because several kinds of PSMA PET tracers are labeled with 18 F or 68 Ga, and each of them may have different biological characteristics (e.g., different physiological distribution and excretion pathways), the standardized evaluation of PROMISE 7 and PSMA-RADS 22 system were introduced to regulate the interpretation of PSMA PET imaging results. PSMA-RADS system is evaluated based on the location of the lesion and the level of PSMA uptake, and it is relatively subjective in judging the degree of PSMA uptake by lesions.…”
Section: Discussionmentioning
confidence: 99%
“…Among them, 68 Ga-PSMA-11 has been approved by the American Food and Drug Administration. 21 Because several kinds of PSMA PET tracers are labeled with 18 F or 68 Ga, and each of them may have different biological characteristics (e.g., different physiological distribution and excretion pathways), the standardized evaluation of PROMISE 7 and PSMA-RADS 22 system were introduced to regulate the interpretation of PSMA PET imaging results. PSMA-RADS system is evaluated based on the location of the lesion and the level of PSMA uptake, and it is relatively subjective in judging the degree of PSMA uptake by lesions.…”
Section: Discussionmentioning
confidence: 99%
“…As peptides account for a substantial proportion of FDAapproved drugs (Al Musaimi et al, 2021), numerous peptide epitopes could potentially be incorporated into lasso peptides to develop new therapeutics (Figure 2C). For example, the two melanocortin receptor agonists setmelanotide and bremelanotide are clinically used to treat obesity and hypoactive sexual desire disorder in women, respectively (Kingsberg et al, 2019;Markham, 2021).…”
Section: Improvement and Expansion Of Lasso Peptide Function By Mutagenesismentioning
confidence: 99%
“…In particular, microbes produce peptide-derived secondary metabolites that exhibit a wide range of activities (Demain, 1999), including compounds that function in quorum-sensing (e.g., N-acyl homoserine lactones), agents that bind and transport metals (e.g., siderophores like enterobactin), and antibiotics that exert a survival advantage against other microbes (e.g., vancomycin) (Williams et al, 1989). Antibiotic resistance has outpaced the discovery of new antibiotics for years; antimicrobial peptides produced by microorganisms have thus attracted considerable attention as promising alternatives to the currently limited antibiotic pipeline (Neu, 1992;Newman and Cragg, 2020;Al Musaimi et al, 2021). Generally, peptide natural products can be classified into several families based on their biosynthetic machinery.…”
Section: Introductionmentioning
confidence: 99%
“…Additionally, over the last 14 decades numerous methods [3] enabling synthesis of a wide range of peptides [4] as well as their large‐scale manufacturing [5] were developed. Owing to their generally attractive pharmacological and safety profiles [6] peptides have been developed as many drugs, [7] with several new approvals appearing each year [8] . Further uses, for example, in material science, [9] cosmeceuticals, [10] and CO 2 capture, [11] have been found; however, despite this breadth of applications in recent years it has been recognized that the profound impact of peptide synthesis on the environment is untenable and more sustainable alternatives are urgently needed [12] .…”
Section: Methodsmentioning
confidence: 99%