PubMed Journals Articles About "Aravive Biologics Initiates Phase Study Novel GAS6 Pathway" RSS

14:53 EST 14th December 2018 | BioPortfolio

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Showing "Aravive Biologics Initiates Phase Study Novel GAS6 Pathway" PubMed Articles 1–25 of 69,000+

Plasma Growth Arrest-Specific 6 Protein and Genetic Variations in the GAS6 Gene in Patients with Metabolic Syndrome.

Growth arrest-specific 6 (Gas6) is a vitamin K-dependent protein secreted by immune cells, endothelial cells, vascular smooth muscle cells, and adipocytes. Recent studies indicate that Gas6 and receptors of the TAM (Tyro3, Axl, and Mer) family may be involved in the pathogenesis of obesity, systemic inflammation, and insulin resistance. The aim of this study was to investigate the association between plasma Gas6 protein and the c.843 + 7G>A Gas6 polymorphism in metabolic syndrome (MetS).

Multiple Roles of Adenomatous Polyposis Coli gene in Wnt Signalling - a Computational Model.

The Adenomatous Polyposis Coli (APC) gene is a multifunctional gene that plays a major role in regulating the Wnt signalling pathway. The Wnt pathway, when activated by Wnt signalling molecules, initiates cell division. Mutation of APC disrupts the regulation and causes continuous activation of the Wnt pathway even in the absence of Wnt signals, thus causing uncontrolled cell proliferation. APC regulates the Wnt pathway by controlling the formation of the nuclear complex β-catenin/TCF that initiates the tr...

The US Biosimilar Market: Stunted Growth and Possible Reforms.

In 2010, Congress created an abbreviated application pathway for biosimilars, versions of approved biologics made by different manufacturers. However, as of November 1, 2018, the Food and Drug Administration had approved only 13 biosimilars under this pathway, of which just 6 were available for patients to use. We review the history of US regulation of biologics and identify manufacturing, regulatory, and marketing issues that have limited biosimilar market entry and uptake, concluding with recommendations ...

The Current Status of Drug Discovery and Development as Originated in US Academia: The Influence of Industrial and Academic Collaboration on Drug Discovery and Development.

Academic drug discovery is a vital component to current drug discovery and development environments. In this study we investigated 798 drug discovery projects that took place between 1991 and 2015 at 36 academic institutions in the US. The observed success rates of academic drug discovery and development were 75% at Phase 1, 50% at Phase 2, 59% at Phase 3, and 88% at the new drug application/biologics license application (NDA/BLA) phase. These results were similar to the corresponding success rates of the p...

Growth arrest-specific gene 6 transfer promotes mesenchymal stem cell survival and cardiac repair under hypoxia and ischemia via enhanced autocrine signaling and paracrine action.

Poor cell viability after transplantation has restricted the therapeutic capacity of mesenchymal stem cells (MSCs) for cardiac dysfunction after myocardial infarction (MI). Growth arrest-specific gene 6 (Gas6) encodes a secreted γ-carboxyglutamic acid (Gla)-containing protein that functions in cell growth, adhesion, chemotaxis, mitogenesis and cell survival. In this study, we genetically modified MSCs with Gas6 and evaluated cell survival, cardiac function, and infarct size in a rat model of MI via intramy...

Ixekizumab provides superior efficacy compared to ustekinumab over 52-weeks of treatment: results from IXORA-S, a phase 3 study.

Biologics targeting interleukin (IL)-17A allow for rapid clearance of psoriatic plaques, with a clinically favorable safety profile.

Dose Increase beyond Labelled Dose of Biologics Is Associated With Incremental Pharmacy Costs: Results from a Real-World Study In the UK.

Evidence regarding dosing patterns of biologics among moderate to severe psoriasis patients and impact on costs in the United Kingdom (UK) is limited.

Considerations for implementing an informatics system to support biologics drug discovery.

A comprehensive, well-functioning and scientifically aware informatics environment is of the utmost importance in supporting effective drug discovery programs. However, implementing such a system can, without a carefully crafted and enacted strategy, be a disruptive and time-consuming process, fraught with risks of cost overruns and the potential to end up with a system that ultimately does not meet the ever-evolving needs of the organization. In this review, using our experience from the software provider ...

In further defense of nonclinical abuse liability testing of biologics.

Risk assessment is not a choice. Drug Abuse Liability (DAL) is mandated under international and national drug control statutes for all drugs targeting the CNS. Once administered to humans many biologics may have long-lived or permanent physiological effects that make DAL testing arduous. We respond to premises of a recently published position on DAL testing of biologics by de Zafra et al. (2018). We propose that, at a minimum, Sponsors submitting a Biologics Licensure Application (BLA) must think "outside t...

Advanced formulations for Intranasal Delivery of Biologics.

The global biologics market has been ever increasing over the last decades and is predicted to top Euro 350 by 2020. Facing this scenario, the parenteral route of biologics administration as hitherto standard route is inconvenient for the future. Among the alternatives, the intranasal delivery of therapeutic biologicals seems to be most promising but researchers are still facing challenges as indicated by the scarce number of successfully marketed peptide drugs.

Patient reported outcomes more important than objective inflammatory markers for sick leave in biologics-treated rheumatoid arthritis patients.

To study the impact of common, non-composite disease activity measures on sick leave in biologics-treated RA-patients.

Aqueous-Phase Oxidation of Terpene-Derived Acids by Atmospherically Relevant Radicals.

Terpene-derived acids formed through the atmospheric gas-phase oxidation of terpenes are able to efficiently undergo a phase transfer into the aqueous phase. The subsequent aqueous-phase oxidation of such compounds has not been intensely studied. Accordingly, the aqueous-phase second order rate constants of the oxidation reactions of cis-pinonic acid (CPA) and (+)-camphoric acid (+CA) with hydroxyl radicals (OH), nitrate radicals (NO) and sulfate radicals (SO) were investigated as a function of temperature ...

A new temperature-dependent strategy to modulate the epidermal growth factor receptor.

The dynamic manipulation of kinases remains a major obstacle to unraveling cell-signaling networks responsible for the activation of biological systems. For example, epidermal growth factor (EGF) stimulates the epidermal growth factor receptor (EGFR/ErbB1); however, EGF also recruits other kinases (HER2/ErbB2) involved with various signaling pathways. To better study EGFR we report a new strategy to selectively activate receptor tyrosine kinases fused to elastin-like polypeptides (ELPs), which can be visual...

Formation of lead ferrites for immobilizing hazardous lead into iron-rich ceramic matrix.

A strategy of immobilizing lead in the framework of ferrite-ceramic matrix, to reduce its environmental hazard was explored in this study. The mechanisms of incorporating lead into lead ferrites (δ-phase (2PbO·FeO), γ-phase (PbO·(2-2.5)FeO) and β-phase (PbO·(5-6)FeO)) was revealed by observing the phase transformation in the products. The δ-phase was dominantly formed at low temperature of 700-800 °C at Pb/Fe of 1/1-1/3. The significant growth of γ-phase was observed at 750-850 °C and Pb/Fe of...

Polymorphic phase transitions in carbamazepine and 10,11-dihydrocarbamazepine.

Temperature-induced phase transitions in carbamazepine (CBZ) and 1,10-dihydrocarbamazepine (DHC) were studied by simultaneous differential scanning calorimetry - X-ray diffraction in this work. The transitions generally involve a transitional melt phase which is quickly followed by recrystallisation. The expansions of the unit cell as a function of temperature could be quantified and allow us to determine a directional order of stability in relation to the lattice constants. Dihydrocarbamazepine form II und...

Persistence of treatment with biologics for patients with psoriasis: a real-world analysis of 16,545 biologic-naïve patients from the French national health insurance database (SNIIRAM).

Long-term clinical effectiveness of biologics in psoriasis is needed.

Tofacitinib Versus Non-Tumor Necrosis Factor Biologics for Patients With Active Rheumatoid Arthritis.

This study aims to compare the disease status of patients with active rheumatoid arthritis (RA) after treatment with tofacitinib or non- tumor necrosis factor (TNF) biologics.

Biologics Monitoring: Incongruity between Recommendations and Clinician Monitoring Trends.

Biologics are a commonly used treatment for moderate to severe psoriasis. Monitoring laboratory test overuse provide little definitive benefit to patients.

Dosing considerations for inhaled biologics.

The number of biologics in the therapeutic development pipeline is increasing including those delivered though inhalation (Morales, 2017; Fathe, 2016). Biologics comprise a broad variety of complex macromolecules with unique physicochemical characteristics. These distinctive characteristics control their pharmacological mechanisms of action, stability, and ultimately affect their processing, formulation, and delivery requirements. This review systematically covers crucial aspects of biologic powders formula...

Adherence and resource use among psoriasis patients treated with biologics.

The emergence of immune-modulating drugs such as biologics has altered the treatment landscape for psoriasis. However, their use presents high financial costs to patients and healthcare systems. Patient demographic and socioeconomic status may influence adherence to biologic medications and usage of healthcare resources. Areas covered: We performed a systematic literature review to summarize the available evidence pertaining to biologic medication adherence and resource use. PubMed was searched using the te...

Why Biologics and Biosimilars Remain So Expensive: Despite Two Wins for Biosimilars, the Supreme Court's Recent Rulings do not Solve Fundamental Barriers to Competition.

Biologics and biosimilars are medicines made from living cells that treat common and serious diseases such as cancer, diabetes, rheumatoid arthritis, and other inflammatory diseases. They are highly targeted, efficacious, and represent an increasingly important part of physicians' armamentaria in the combat against these medical conditions. Yet they are extremely expensive, costing on average $10,000-$30,000 per year and exceed $500,000 for the most expensive biologics. The advent of biosimilar drugs, or hi...

A comparison between phase-III trials and a phase-IV study of nalmefene in alcohol use disorder patients. Is there a difference?

Concerns regarding the external validity of phase-III trials are common to many medical disciplines, with relevant discrepancies found between experimental and clinical samples in some diseases such as hypertension. The aim of this study was to compare the samples included in the pivotal, phase-III clinical trials of nalmefene with that of a recently conducted phase-IV trial. Baseline characteristics of the studies were compared through univariate analysis. Significant differences were found in the percenta...

Melatonin induces mechanisms of brain resilience against neurodegeneration.

Melatonin is an endogenous pleiotropic molecule which orchestrates regulatory functions and protective capacity against age-related ailments. The increase in circulating levels of melatonin through dietary supplements intensifies its health benefits. Investigations in animal models have shown that melatonin protects against Alzheimer's disease (AD)-like pathology, although clinical studies have not been conclusive. We hypothesized that melatonin induces changes in the brain that prevent or attenuate AD by i...

RGNNV-induced cell cycle arrest at G1/S phase enhanced viral replication via p53-dependent pathway in GS cells.

Nervous necrosis virus (NNV) is a ubiquitous pathogen in the aquaculture worldwide. Little is known about the relationship between NNV virus and host cells. Our studies showed that RGNNV infection could induce cell cycle arrest via activation of p53 signaling in cultured host cells. Infection of RGNNV redistributed NPM1, stabilized p53 and inhibited cell proliferation by inducing G1 arrest. RGNNV infection also led to phosphorylation and accumulation of p53 in a time-dependent manner. Furthermore, RGNNV inf...

The Receptor Tyrosine Kinase AXL Is Required at Multiple Steps of the Metastatic Cascade during HER2-Positive Breast Cancer Progression.

AXL is activated by its ligand GAS6 and is expressed in triple-negative breast cancer cells. In the current study, we report AXL expression in HER2-positive (HER2) breast cancers where it correlates with poor patient survival. Using murine models of HER2 breast cancer, Axl, but not its ligand Gas6, was found to be essential for metastasis. We determined that AXL is required for intravasation, extravasation, and growth at the metastatic site. We found that AXL is expressed in HER2 cancers displaying epitheli...

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