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Topic Review
The Coming of Age of Biosimilars
The first biosimilar, Sandoz’s Omnitrope  (human growth hormone), was approved in 2006 by both the FDA and EMA; it was approved by the FDA under the 505(b)(2) generic product legislation and by the EU as a biosimilar. Later, Sandoz received the first licensing of Zarzio/Zarxio (filgrastim) in 2015; this was the first biosimilar product approved under the 351(k) BLA legislation in the US. Biosimilars have come of age from 2005 to the present, with 84 approvals in the EU and 35 in the US, representing almost 90% of the world market. While the acceptance of biosimilars in the US is catching up with that in the EU, the cost benefits remain elusive due to the high development barrier and complex distribution system involved, mainly in the US. In the EU, the cost of biosimilars has already dropped 70% or more, and interchangeability is a routine in some European jurisdictions, unlike in the US, where a separate regulatory approval is required.
  • 1.2K
  • 27 Apr 2022
Topic Review
Chromatographic Techniques in Pharmaceutical Analysis
High-performance liquid chromatography (HPLC) is an incredibly universal tool, especially when combined with different detectors, such as UV-Visible spectroscopy, mass spectrometry (MS), and fluorescence detection for numerous active ingredients in different pharmaceutical formulations without interferences from other excipients. TLC, in combination with densitometry, is a very efficient tool for the determination of biologically active substances present in pharmaceutical preparations. In addition, TLC coupled to densitometry and mass spectrometry could be suitable for preliminary screening and determination of the biological activity (e.g., antioxidant properties, thin layer chromatography (TLC) by 2,2-diphenyl-1-picrylhydrazyl (DPPH) method) of plant materials. Gas chromatography, coupled with a mass spectrometer (GC-MS, GC-MS/MS), is of particular importance in the testing of any volatile substances, such as essential oils. LC, coupled to NMR and MS, is the best solution for identifying and studying the structure of unknown components from plant extracts, as well as degradation products (DPs). Thanks to size-exclusion chromatography, coupled to multi-angle light scattering, the quality control of biological pharmaceuticals is possible.
  • 3.1K
  • 26 Apr 2022
Topic Review
Nanotherapeutic Approaches to Overcome Drug Resistance in Cancers
Nanotherapeutics serve not so much to overcome the chemotherapeutic treatment, but rather to overcome the chemoresistance of cancers, improve pharmacokinetics of the drugs, and decrease or eliminate their systemic toxicity and so on. The foremost objective of the nanotherapeutics-based approach is to target specific cancer cells and their microenvironment with minimal toxicity by delivering chemotherapeutic agents efficiently to the target site. Moreover, the development of nanotherapeutics in the past few years indicates its considerable potential in the cancer therapeutic domain.
  • 560
  • 22 Apr 2022
Topic Review
Equipoise in Immunotherapy Era. Treating Autoimmunity or Cancer
Numerous immunotherapeutic agents, such as immune checkpoint inhibitors (ICIs), have been approved for the treatment of genitourinary (GU) malignancies. While ICIs have improved treatment outcomes and expanded treatment options, they can cause immune-related adverse events (irAEs). 
  • 407
  • 21 Apr 2022
Topic Review
NO in Viral Infections
Nitric oxide is a ubiquitous signaling radical that influences critical body functions. Its importance in the cardiovascular system and the innate immune response to bacterial and viral infections has been extensively investigated. The overproduction of NO is an early component of viral infections, including those affecting the respiratory tract. The production of high levels of NO is due to the overexpression of NO biosynthesis by inducible NO synthase (iNOS), which is involved in viral clearance. The development of NO-based antiviral therapies, particularly gaseous NO inhalation and NO-donors, has proven to be an excellent antiviral therapeutic strategy. 
  • 505
  • 20 Apr 2022
Topic Review
Immunotherapy for Cutaneous Malignant Melanoma
Malignant melanoma (mM) is the leading cause of death among cutaneous malignancies. While its incidence is increasing, the most recent cancer statistics show a small but clear decrease in mortality rate. This trend reflects the introduction of novel and more effective therapeutic regimens, including the two cornerstones of melanoma therapy: immunotherapies and targeted therapies. Unlike chemotherapies or radiation, in which the therapy directly induces cancer cell death, immunotherapies stimulate the patient’s immune system to control and eliminate the tumor. Advantages of immunotherapies over traditional cancer treatments include increased durability for long-term control or even cure and more precisely targeted anti-tumor activity that spares healthy tissues, many times with comparable or even reduced overall toxicity. The high immunogenicity and somatic mutation burden of melanoma likely contribute to the success of immunotherapy. Treatments combining immunotherapies with targeted therapies, which disable the carcinogenic products of mutated cancer cells, have further increased treatment efficacy and durability. Toxicity and resistance, however, remain critical challenges to the field. There are three types of immunotherapies currently approved by the US Food and Drug Administration (FDA) for the treatment of advanced melanoma: (1) T-cell stimulating cytokines (i.e. interferon (IFN)-α2b and interleukin-2 (IL-2)); (2) T-cell exhaustion-mitigating immune checkpoint inhibitors (ICI); and (3) a dendritic cell (DC)-activating oncolytic virus (T-VEC). Still others, such as adoptive cell transfer (ACT), hold strong promise for the future.
  • 494
  • 20 Apr 2022
Topic Review
Histone Deacetylases in Human Cancers
Histone modification is an essential mark in maintaining cellular memory and, therefore, loss of this mark can lead to tumor transformation. As these epigenetic changes are reversible, the use of molecules that can restore the functions of the enzymes responsible for the changes is therapeutically necessary. Natural molecules, mainly those isolated from medicinal plants, have demonstrated significant inhibitory properties against enzymes related to histone modifications, particularly histone deacetylases (HDACs). Flavonoids, terpenoids, phenolic acids, and alkaloids exert significant inhibitory effects against HDAC and exhibit promising epi-drug properties. This suggests that epi-drugs against HDAC could prevent and treat various human cancers. 
  • 493
  • 20 Apr 2022
Topic Review
Magnetic Resonance Imaging on Pregnant Women
Pregnancy is a delicate state, during which timely investigation of possible physiological anomalies is essential to reduce the risk of maternal and fetal complications. Medical imaging encompasses different technologies to image the human body for the diagnosis, course of treatment management, and follow-up of diseases. Ultrasound (US) is currently the imaging system of choice for pregnant patients. However, sonographic evaluations can be non-effective or give ambiguous results. Therefore, magnetic resonance imaging (MRI), due to its excellent tissue penetration, the possibility of acquisition of three-dimensional anatomical information, and its high spatial resolution, is considered a valid diagnostical alternative.
  • 1.1K
  • 19 Apr 2022
Topic Review
Natural Products in the Model Organism Caenorhabditis elegans
Natural products are small molecules naturally produced by multiple sources such as plants, animals, fungi, bacteria and archaea. They exert both beneficial and detrimental effects by modulating biological targets and pathways involved in oxidative stress and antioxidant response. Natural products’ oxidative or antioxidative properties are usually investigated in preclinical experimental models, including virtual computing simulations, cell and tissue cultures, rodent and nonhuman primate animal models, and human studies.
  • 340
  • 15 Apr 2022
Topic Review
Lectin Protein
Lectins are natural proteins with the ability to bind specific carbohydrates related to various microorganisms, including viruses, bacteria, fungi and parasites. Lectins have the ability to agglutinate and neutralize these pathogeneses. The delivery of the encapsulated antiviral agents or vaccines across the cell membrane can be possible by functionalized micellar and liposomal formulations. 
  • 815
  • 14 Apr 2022
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