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143 Results Found

  • Feature Paper
  • Communication
  • Open Access
3,852 Views
5 Pages

Facilitating a More Efficient Commercial Review Process for Pediatric Drugs and Biologics

  • Ryan D. Rykhus,
  • Zachary V. Shepard,
  • Alix Young,
  • Hadley Frisby,
  • Kailee A. Calder,
  • Collin M. Coon,
  • Justin A. Falk,
  • Sydney R. McAndrews,
  • Aspen Turner and
  • Mark A. Brown
  • + 9 authors

22 December 2017

Over the past two decades, the biopharmaceutical industry has seen unprecedented expansion and innovation in concert with significant technological advancements. While the industry has experienced marked growth, the regulatory system in the United St...

  • Article
  • Open Access
10 Citations
9,984 Views
18 Pages

Compounded Nonsterile Preparations and FDA-Approved Commercially Available Liquid Products for Children: A North American Update

  • Richard H. Parrish,
  • Lisa D. Ashworth,
  • Raimar Löbenberg,
  • Sandra Benavides,
  • Jeffrey J. Cies and
  • Robert B. MacArthur

The purpose of this work was to evaluate the suitability of recent US Food and Drug Administration (US-FDA)-approved and marketed oral liquid, powder, or granule products for children in North America, to identify the next group of Active Pharmaceuti...

  • Review
  • Open Access
509 Citations
31,170 Views
20 Pages

More than 3000 antimicrobial peptides (AMPs) have been discovered, seven of which have been approved by the U.S. Food and Drug Administration (FDA). Now commercialized, these seven peptides have mostly been utilized for topical medications, though so...

  • Review
  • Open Access
28 Citations
10,343 Views
33 Pages

Journey to the Market: The Evolution of Biodegradable Drug Delivery Systems

  • Minze Zhu,
  • Andrew K. Whittaker,
  • Felicity Y. Han and
  • Maree T. Smith

17 January 2022

Biodegradable polymers have been used as carriers in drug delivery systems for more than four decades. Early work used crude natural materials for particle fabrication, whereas more recent work has utilized synthetic polymers. Applications include th...

  • Review
  • Open Access
1,012 Citations
51,990 Views
23 Pages

17 February 2022

Liposomes have been considered promising and versatile drug vesicles. Compared with traditional drug delivery systems, liposomes exhibit better properties, including site-targeting, sustained or controlled release, protection of drugs from degradatio...

  • Review
  • Open Access
4 Citations
3,366 Views
14 Pages

1 February 2024

Amyotrophic lateral sclerosis (ALS) is a rare progressive motor neuron disease that, due to its high complexity, still lacks effective treatments. Development of a new drug is a highly costly and time-consuming process, and the repositioning of appro...

  • Review
  • Open Access
72 Citations
7,699 Views
28 Pages

Review of Contemporary Self-Assembled Systems for the Controlled Delivery of Therapeutics in Medicine

  • Laura L. Osorno,
  • Alyssa N. Brandley,
  • Daniel E. Maldonado,
  • Alex Yiantsos,
  • Robert J. Mosley and
  • Mark E. Byrne

21 January 2021

The novel and unique design of self-assembled micro and nanostructures can be tailored and controlled through the deep understanding of the self-assembly behavior of amphiphilic molecules. The most commonly known amphiphilic molecules are surfactants...

  • Review
  • Open Access
259 Citations
20,655 Views
19 Pages

A Comprehensive Map of FDA-Approved Pharmaceutical Products

  • Hao Zhong,
  • Ging Chan,
  • Yuanjia Hu,
  • Hao Hu and
  • Defang Ouyang

With the increasing research and development (R&D) difficulty of new molecular entities (NMEs), novel drug delivery systems (DDSs) are attracting widespread attention. This review investigated the current distribution of Food and Drug Administrat...

  • Review
  • Open Access
141 Citations
10,885 Views
24 Pages

22 September 2020

Traditionally, drug discovery utilises a de novo design approach, which requires high cost and many years of drug development before it reaches the market. Novel drug development does not always account for orphan diseases, which have low demand and...

  • Article
  • Open Access
34 Citations
5,883 Views
11 Pages

18 November 2020

Previously, our group predicted commercially available Food and Drug Administration (FDA) approved drugs that can inhibit each step of the replication of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using a deep learning-based drug-ta...

  • Review
  • Open Access
146 Citations
19,167 Views
29 Pages

A Review of 3D Printing Technology in Pharmaceutics: Technology and Applications, Now and Future

  • Shanshan Wang,
  • Xuejun Chen,
  • Xiaolu Han,
  • Xiaoxuan Hong,
  • Xiang Li,
  • Hui Zhang,
  • Meng Li,
  • Zengming Wang and
  • Aiping Zheng

Three-dimensional printing technology, also called additive manufacturing technology, is used to prepare personalized 3D-printed drugs through computer-aided model design. In recent years, the use of 3D printing technology in the pharmaceutical field...

  • Review
  • Open Access
3,973 Citations
112,677 Views
21 Pages

26 August 2011

In past two decades poly lactic-co-glycolic acid (PLGA) has been among the most attractive polymeric candidates used to fabricate devices for drug delivery and tissue engineering applications. PLGA is biocompatible and biodegradable, exhibits a wide...

  • Review
  • Open Access
26 Citations
5,512 Views
17 Pages

Availability of Authorizations from EMA and FDA for Age-Appropriate Medicines Contained in the WHO Essential Medicines List for Children 2019

  • Jose-Manuel delMoral-Sanchez,
  • Isabel Gonzalez-Alvarez,
  • Marta Gonzalez-Alvarez,
  • Andres Navarro-Ruiz and
  • Marival Bermejo

Lack of age-appropriate commercially drug products availability is a common problem in pediatric therapeutics; this population needs improved and safer drug delivery. In addition, biopharmaceutic aspects, dosage requirements, and swallowing abilities...

  • Article
  • Open Access
13 Citations
4,870 Views
23 Pages

Small Molecules as Toll-like Receptor 4 Modulators Drug and In-House Computational Repurposing

  • Lucía Pérez-Regidor,
  • Joan Guzmán-Caldentey,
  • Nils Oberhauser,
  • Carmen Punzón,
  • Balázs Balogh,
  • José R. Pedro,
  • Eva Falomir,
  • Alessandra Nurisso,
  • Péter Mátyus and
  • Sonsoles Martín-Santamaría
  • + 2 authors

19 September 2022

The innate immunity toll-like receptor 4 (TLR4) system is a receptor of paramount importance as a therapeutic target. Virtual screening following a “computer-aided drug repurposing” approach was applied to the discovery of novel TLR4 modu...

  • Communication
  • Open Access
13 Citations
4,410 Views
11 Pages

12 March 2019

Epidemic keratoconjunctivitis (EKC) is a severe ocular disease and can lead to visual impairment. Human adenovirus type-37 (HAdV-D37) is one of the major causative agents of EKC and uses sialic acid (SA)-containing glycans as cellular receptors. Curr...

  • Article
  • Open Access
73 Citations
13,177 Views
16 Pages

Biosimilar medicines expand the biotherapeutic market and improve patient access. This work looked into the landscape of the European and US biosimilar products, their regulatory authorization, market availability, and clinical evaluation undergone p...

  • Data Descriptor
  • Open Access
4 Citations
4,971 Views
19 Pages

CoviRx: A User-Friendly Interface for Systematic Down-Selection of Repurposed Drug Candidates for COVID-19

  • Hardik A. Jain,
  • Vinti Agarwal,
  • Chaarvi Bansal,
  • Anupama Kumar,
  • Faheem,
  • Muzaffar-Ur-Rehman Mohammed,
  • Sankaranarayanan Murugesan,
  • Moana M. Simpson,
  • Avinash V. Karpe and
  • Seshadri S. Vasan
  • + 9 authors

18 November 2022

Although various vaccines are now commercially available, they have not been able to stop the spread of COVID-19 infection completely. An excellent strategy to get safe, effective, and affordable COVID-19 treatments quickly is to repurpose drugs that...

  • Article
  • Open Access
35 Citations
5,870 Views
17 Pages

Exploring the SARS-CoV-2 Proteome in the Search of Potential Inhibitors via Structure-Based Pharmacophore Modeling/Docking Approach

  • Giulia Culletta,
  • Maria Rita Gulotta,
  • Ugo Perricone,
  • Maria Zappalà,
  • Anna Maria Almerico and
  • Marco Tutone

To date, SARS-CoV-2 infectious disease, named COVID-19 by the World Health Organization (WHO) in February 2020, has caused millions of infections and hundreds of thousands of deaths. Despite the scientific community efforts, there are currently no ap...

  • Review
  • Open Access
73 Citations
13,492 Views
21 Pages

Since the discovery of camelid heavy-chain antibodies in 1993, there has been tremendous excitement for these antibody domains (VHHs/sdAbs/nanobodies) as research tools, diagnostics, and therapeutics. Commercially, several patents were granted to pio...

  • Review
  • Open Access
33 Citations
6,756 Views
31 Pages

Commercially Available Cell-Free Permeability Tests for Industrial Drug Development: Increased Sustainability through Reduction of In Vivo Studies

  • Ann-Christin Jacobsen,
  • Sonja Visentin,
  • Cosmin Butnarasu,
  • Paul C. Stein and
  • Massimiliano Pio di Cagno

Replacing in vivo with in vitro studies can increase sustainability in the development of medicines. This principle has already been applied in the biowaiver approach based on the biopharmaceutical classification system, BCS. A biowaiver is a regulat...

  • Brief Report
  • Open Access
37 Citations
10,024 Views
9 Pages

Omadacycline (Nuzyra®) is a new aminomethylcycline, approved by the U. S. Food and Drug Administration in 2018, as a tetracycline antibacterial. It can be used in community-acquired pneumonia and in acute bacterial skin and skin-structure infecti...

  • Review
  • Open Access
18 Citations
4,545 Views
19 Pages

10 March 2023

Exosomes are cell-derived, nano-sized extracellular vesicles comprising a lipid bilayer membrane that encapsulates several biological components, such as nucleic acids, lipids, and proteins. The role of exosomes in cell–cell communication and c...

  • Article
  • Open Access
5 Citations
3,727 Views
37 Pages

Identification of Modulators of HIV-1 Proviral Transcription from a Library of FDA-Approved Pharmaceuticals

  • Gavin C. Sampey,
  • Sergey Iordanskiy,
  • Michelle L. Pleet,
  • Catherine DeMarino,
  • Fabio Romerio,
  • Renaud Mahieux and
  • Fatah Kashanchi

23 September 2020

Human immunodeficiency virus 1 (HIV-1) is the most prevalent human retrovirus. Recent data show that 34 million people are living with HIV-1 worldwide. HIV-1 infections can lead to AIDS which still causes nearly 20,000 deaths annually in the USA alon...

  • Review
  • Open Access
22 Citations
6,136 Views
16 Pages

Repurposing Old Drugs into New Epigenetic Inhibitors: Promising Candidates for Cancer Treatment?

  • Filipa Moreira-Silva,
  • Vânia Camilo,
  • Vítor Gaspar,
  • João F. Mano,
  • Rui Henrique and
  • Carmen Jerónimo

Epigenetic alterations, as a cancer hallmark, are associated with cancer initiation, progression and aggressiveness. Considering, however, that these alterations are reversible, drugs that target epigenetic machinery may have an inhibitory effect upo...

  • Review
  • Open Access
21 Citations
18,654 Views
43 Pages

Sildenafil 4.0—Integrated Synthetic Chemistry, Formulation and Analytical Strategies Effecting Immense Therapeutic and Societal Impact in the Fourth Industrial Era

  • Andreas Ouranidis,
  • Anastasia Tsiaxerli,
  • Elisavet Vardaka,
  • Catherine K. Markopoulou,
  • Constantinos K. Zacharis,
  • Ioannis Nicolaou,
  • Dimitris Hatzichristou,
  • Anna-Bettina Haidich,
  • Nikolaos Kostomitsopoulos and
  • Kyriakos Kachrimanis

15 April 2021

Sildenafil is a potent selective, reversible inhibitor of phosphodiesterase type 5 (PDE5) approved for the treatment of erectile dysfunction and pulmonary arterial hypertension. Whilst twenty years have passed since its original approval by the US Fo...

  • Article
  • Open Access
1 Citations
6,295 Views
10 Pages

20 July 2023

Foundation Medicine® testing is a next-generation sequence (NGS)-based platform that allows clinicians to obtain the comprehensive genomic profiling (CGP) of several cancers. By using NGS approaches, relevant genomic alterations can be identified...

  • Review
  • Open Access
1,819 Views
13 Pages

Drug Repurposing of New Treatments for Neuroendocrine Tumors

  • Stefania Bellino,
  • Daniela Lucente and
  • Anna La Salvia

28 July 2025

Drug repurposing or drug repositioning is the process of identifying new therapeutic uses for approved or investigational drugs beyond the original treatment indication. The discovery of new drugs for cancer therapy needs this cost-effective and time...

  • Review
  • Open Access
39 Citations
5,906 Views
19 Pages

From Nanoparticles to Cancer Nanomedicine: Old Problems with New Solutions

  • Chi-Ling Chiang,
  • Ming-Huei Cheng and
  • Chih-Hsin Lin

30 June 2021

Anticancer nanomedicines have been studied over 30 years, but fewer than 10 formulations have been approved for clinical therapy today. Despite abundant options of anticancer drugs, it remains challenging to have agents specifically target cancer cel...

  • Review
  • Open Access
4 Citations
5,289 Views
31 Pages

Obeticholic Acid and Other Farnesoid-X-Receptor (FXR) Agonists in the Treatment of Liver Disorders

  • Stefano Fiorucci,
  • Ginevra Urbani,
  • Eleonora Distrutti and
  • Michele Biagioli

22 September 2025

The Farnesoid-X-receptor (FXR) is a bile sensor involved in the regulation of bile acid homeostasis, fibrosis, inflammation, and metabolism. Obeticholic acid (OCA), a semisynthetic derivative of chenodeoxycholic acid (CDCA), initially named 6-ethyl-C...

  • Review
  • Open Access
72 Citations
15,944 Views
21 Pages

Naturapolyceutics: The Science of Utilizing Natural Polymers for Drug Delivery

  • Ndidi C. Ngwuluka,
  • Nelson A. Ochekpe and
  • Okezie I. Aruoma

5 May 2014

Naturapolyceutics defines the emerging science and technology platform that blends natural polymers and pharmaceutics for the design and development of drug delivery systems. Natural polymers due to their biological properties, sustainability, chemic...

  • Review
  • Open Access
26 Citations
5,588 Views
15 Pages

iPSCs: A Preclinical Drug Research Tool for Neurological Disorders

  • Gabriele Bonaventura,
  • Rosario Iemmolo,
  • Giuseppe Antonino Attaguile,
  • Valentina La Cognata,
  • Brigida Sabrina Pistone,
  • Giuseppe Raudino,
  • Velia D’Agata,
  • Giuseppina Cantarella,
  • Maria Luisa Barcellona and
  • Sebastiano Cavallaro

The development and commercialization of new drugs is an articulated, lengthy, and very expensive process that proceeds through several steps, starting from target identification, screening new leading compounds for testing in preclinical studies, an...

  • Article
  • Open Access
13 Citations
6,396 Views
14 Pages

Inhibitory Effects of Antiviral Drug Candidates on Canine Parvovirus in F81 cells

  • Hongzhuan Zhou,
  • Xia Su,
  • Lulu Lin,
  • Jin Zhang,
  • Qi Qi,
  • Fangfang Guo,
  • Fuzhou Xu and
  • Bing Yang

13 August 2019

Canine parvovirus (CPV) is a common etiological agent of acute enteritis, which occurs globally in domestic and wild carnivores. Despite the widespread use of inactivated or live attenuated vaccines, the emergence of antigenic variants and the influe...

  • Review
  • Open Access
14 Citations
11,414 Views
14 Pages

3 November 2020

G-protein-coupled receptors (GPCR) transmit extracellular signals into cells to regulate a variety of cellular functions and are closely related to the homeostasis of the human body and the progression of various types of diseases. Great attention ha...

  • Review
  • Open Access
32 Citations
2,632 Views
9 Pages

1 April 2020

Adoptive cellular therapy with chimeric antigen receptor T cells (car-ts) has recently received approval from Health Canada and the U.S. Food and Drug Administration after remarkable and durable remissions were seen in children with recurrent or refr...

  • Article
  • Open Access
11 Citations
4,244 Views
13 Pages

5 April 2023

Alzheimer is a severe memory and cognitive impairment neurodegenerative disease that is the most common cause of dementia worldwide and characterized by the pathological accumulation of tau protein and amyloid-beta peptides. In this study, we have de...

  • Communication
  • Open Access
16 Citations
6,509 Views
10 Pages

Antibacterial Drug Development: A New Approach Is Needed for the Field to Survive and Thrive

  • M. Courtney Safir,
  • Sujata M. Bhavnani,
  • Christine M. Slover,
  • Paul G. Ambrose and
  • Christopher M. Rubino

It is often said that the marketplace for new antibiotics is broken. This notion is supported by the observation that many recently-approved antibiotics to treat drug-resistant bacteria have failed commercially in a spectacular fashion. Today, compan...

  • Review
  • Open Access
63 Citations
9,806 Views
30 Pages

24 June 2021

Dolastatin 10 (Dol-10), a leading marine pentapeptide isolated from the Indian Ocean mollusk Dolabella auricularia, contains three unique amino acid residues. Dol-10 can effectively induce apoptosis of lung cancer cells and other tumor cells at nanom...

  • Review
  • Open Access
2 Citations
8,899 Views
37 Pages

Current Trends in Clinical Trials of Prodrugs

  • Diogo Boreski,
  • Valentine Fabienne Schmid,
  • Priscila Longhin Bosquesi,
  • Jean Leandro dos Santos,
  • Cauê Benito Scarim,
  • Viktor Reshetnikov and
  • Chung Man Chin

4 February 2025

The development of new drugs is a lengthy and complex process regarding its conception and ideation, passing through in silico studies, synthesis, in vivo studies, clinical trials, approval, and commercialization, with an exceptionally low success ra...

  • Review
  • Open Access
1,656 Views
26 Pages

Survey on the Global Technological Status for Forecasting the Industrialization Timeline of Cultured Meat

  • Young-Hwa Hwang,
  • SoHee Kim,
  • ChanJin Kim,
  • Swati Kumari,
  • SiHoon An and
  • Seon-Tea Joo

9 December 2025

Cultured meat has progressed from early in vitro cell culture concepts to regulatory approvals and preliminary commercialization, with recent advancements propelled by interdisciplinary innovations in cell line engineering, serum-free media, bioreact...

  • Article
  • Open Access
2 Citations
2,882 Views
15 Pages

Fragment Library of Colombian Natural Products: Generation and Comparative Chemoinformatic Analysis

  • Ana L. Chávez-Hernández,
  • Johny R. Rodríguez-Pérez,
  • Héctor F. Cortés-Hernández,
  • Hoover A. Valencia-Sanchez,
  • Miguel Á. Chávez-Fumagalli and
  • José L. Medina-Franco

29 October 2024

Fragment libraries have a major significance in drug discovery due to their role in de novo design and enumerating large and ultra-large compound libraries. Although several fragment libraries are commercially available, most are derived from synthet...

  • Article
  • Open Access
3 Citations
5,232 Views
10 Pages

Targeting the Class A Carbapenemase GES-5 via Virtual Screening

  • Raphael Klein,
  • Laura Cendron,
  • Martina Montanari,
  • Pierangelo Bellio,
  • Giuseppe Celenza,
  • Lorenzo Maso,
  • Donatella Tondi and
  • Ruth Brenk

14 February 2020

The worldwide spread of β-lactamases able to hydrolyze last resort carbapenems contributes to the antibiotic resistance problem and menaces the successful antimicrobial treatment of clinically relevant pathogens. Class A carbapenemases include m...

  • Review
  • Open Access
43 Citations
9,314 Views
25 Pages

Fungal Drug Discovery for Chronic Disease: History, New Discoveries and New Approaches

  • Thomas A. K. Prescott,
  • Rowena Hill,
  • Eduard Mas-Claret,
  • Ester Gaya and
  • Edie Burns

14 June 2023

Fungal-derived drugs include some of the most important medicines ever discovered, and have proved pivotal in treating chronic diseases. Not only have they saved millions of lives, but they have in some cases changed perceptions of what is medically...

  • Article
  • Open Access
2 Citations
3,944 Views
14 Pages

Concanavalin a Grafted Nanoemulsions for Nasal Delivery: Preliminary Studies with Fluorescently Labelled Formulations

  • Merve Mışraklı,
  • Sebastiano Antonio Rizzo,
  • Valentina Bordano,
  • Annalisa Bozza,
  • Luca Ferraris,
  • Elisabetta Marini,
  • Elisabetta Muntoni,
  • Maria Teresa Capucchio,
  • Anna Scomparin and
  • Luigi Battaglia

11 October 2024

Nasal delivery is a non-invasive strategy for effective drug delivery. Nevertheless, in order to promote drug uptake by the nasal mucosa, it is fundamental to increase its residence time in the administration site. To this aim, nano-sized drug delive...

  • Article
  • Open Access
29 Citations
4,000 Views
19 Pages

Design of Topical Moxifloxacin Mucoadhesive Nanoemulsion for the Management of Ocular Bacterial Infections

  • Ahmed Adel Ali Youssef,
  • Ruchi Thakkar,
  • Samir Senapati,
  • Poorva H. Joshi,
  • Narendar Dudhipala and
  • Soumyajit Majumdar

Ocular bacterial infections can lead to serious visual disability without proper treatment. Moxifloxacin (MOX) has been approved by the US Food and Drug Administration as a monotherapy for ocular bacterial infections and is available commercially as...

  • Article
  • Open Access
15 Citations
4,676 Views
12 Pages

A Drug Screening Revealed Novel Potential Agents against Malignant Pleural Mesothelioma

  • Irene Dell’Anno,
  • Alessandra Melani,
  • Sarah A. Martin,
  • Marcella Barbarino,
  • Roberto Silvestri,
  • Monica Cipollini,
  • Antonio Giordano,
  • Luciano Mutti,
  • Andrea Nicolini and
  • Stefano Landi
  • + 2 authors

20 May 2022

The lack of effective therapies remains one of the main challenges for malignant pleural mesothelioma (MPM). In this perspective, drug repositioning could accelerate the identification of novel treatments. We screened 1170 FDA-approved drugs on a SV4...

  • Review
  • Open Access
3 Citations
3,444 Views
9 Pages

8 September 2024

The use of chimeric antigen receptors (CAR T-cells) for the treatment of patients with malignant haematological diseases has become a well-established application for conditions such as refractory or relapsed B-cell acute lymphoblastic leukaemia (B-A...

  • Review
  • Open Access
6 Citations
7,618 Views
10 Pages

Aligning the Economic Value of Companion Diagnostics and Stratified Medicines

  • Edward D. Blair,
  • Elyse K. Stratton and
  • Martina Kaufmann

26 November 2012

The twin forces of payors seeking fair pricing and the rising costs of developing new medicines has driven a closer relationship between pharmaceutical companies and diagnostics companies, because stratified medicines, guided by companion diagnostics...

  • Review
  • Open Access
78 Citations
7,983 Views
24 Pages

26 February 2021

Various bone graft products are commercially available worldwide. However, there is no clear consensus regarding the appropriate bone graft products in different clinical situations. This review is intended to summarize bone graft products, especiall...

  • Review
  • Open Access
33 Citations
6,215 Views
57 Pages

Do Lipid-based Nanoparticles Hold Promise for Advancing the Clinical Translation of Anticancer Alkaloids?

  • Jian Sheng Loh,
  • Li Kar Stella Tan,
  • Wai Leng Lee,
  • Long Chiau Ming,
  • Chee Wun How,
  • Jhi Biau Foo,
  • Nurolaini Kifli,
  • Bey Hing Goh and
  • Yong Sze Ong

25 October 2021

Since the commercialization of morphine in 1826, numerous alkaloids have been isolated and exploited effectively for the betterment of mankind, including cancer treatment. However, the commercialization of alkaloids as anticancer agents has generally...

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