Food and Drug Administration (FDA) Research This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

Assessment of CYP-Mediated Drug Interactions for Enasidenib Based on a Cocktail Study in Patients with Relapse or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
J Clin Pharmacol. 2024 Apr 2. doi: 10.1002/jcph.2436. Online ahead of print.ABSTRACTAs a selective and potent inhibitor targeting the isocitrate dehydrogenase-2 (IDH2) mutant protein, enasidenib obtained approval from the US Food and Drug Administration (FDA) in 2017 for adult patients with acute myeloid leukemia (AML) with an IDH2 mutation. In vitro investigations demonstrated that enasidenib affects various drug metabolic enzymes and transporters. This current investigation aimed to assess enasidenib on the pharmacokinetics (PKs) of CYP substrates, including dextromethorphan (CYP2D6 probe drug), flurbiprofen (CYP2C9 prob...
Source: The Journal of Clinical Pharmacology - April 2, 2024 Category: Drugs & Pharmacology Authors: Yiming Cheng Xiaomin Wang Atalanta Ghosh Jie Pu Leonidas N Carayannopoulos Yan Li Source Type: research

Utah flouts FDA with law greenlighting placental stem cell therapies
The state of Utah is challenging the authority of the U.S. Food and Drug Administration (FDA) with a new, unusually bold law that allows patients to receive unapproved placental stem cell “therapies.” Observers predict that the law, which takes effect on 1 May, could significantly undermine FDA’s authority to regulate drugs and other treatments. The new statute , passed almost unanimously by both houses of the Utah legislature in February and signed by Governor Spencer Cox (R) last month, declares that Utah health care providers “may perform a [placental] stem cell therapy that is not approved by [F...
Source: Science of Aging Knowledge Environment - April 1, 2024 Category: Geriatrics Source Type: research

High systemic inflammation as a novel cardiovascular risk factor and target for anti-cytokine therapy: comment regarding the triglyceride glucose index
Int J Cardiovasc Imaging. 2024 Apr 1. doi: 10.1007/s10554-024-03046-6. Online ahead of print.ABSTRACTIn the last century, there has been more than enough research that proved the association of high lipid and glucose levels with cardiovascular disease, thus establishing the current well-known traditional cardiovascular risk factors such as dyslipidemia, diabetes, and metabolic syndrome. Hence, these cardiovascular risk factors are target therapy for glucose and lipid-lowering agents to prevent adverse cardiovascular events. However, despite controlling the lipid and glucose levels, some studies demonstrated the subclinical...
Source: Atherosclerosis - April 1, 2024 Category: Cardiology Authors: Artemio Garc ía-Escobar Rosa L ázaro-García Jos é-Ángel Cabrera Alfonso Jurado-Rom án Ra úl Moreno Source Type: research

Formulating biopharmaceuticals using three-dimensional printing
J Pharm Pharm Sci. 2024 Mar 15;27:12797. doi: 10.3389/jpps.2024.12797. eCollection 2024.ABSTRACTAdditive manufacturing, commonly referred to as three-dimensional (3D) printing, has the potential to initiate a paradigm shift in the field of medicine and drug delivery. Ever since the advent of the first-ever United States Food and Drug Administration (US FDA)-approved 3D printed tablet, there has been an increased interest in the application of this technology in drug delivery and biomedical applications. 3D printing brings us one step closer to personalized medicine, hence rendering the "one size fits all" concept in drug d...
Source: J Pharm Pharm Sci - April 1, 2024 Category: Drugs & Pharmacology Authors: Alistair K C Chan Nehil Ranjitham Gopalakrishnan Yannick Leandre Traore Emmanuel A Ho Source Type: research

Formulating biopharmaceuticals using three-dimensional printing
J Pharm Pharm Sci. 2024 Mar 15;27:12797. doi: 10.3389/jpps.2024.12797. eCollection 2024.ABSTRACTAdditive manufacturing, commonly referred to as three-dimensional (3D) printing, has the potential to initiate a paradigm shift in the field of medicine and drug delivery. Ever since the advent of the first-ever United States Food and Drug Administration (US FDA)-approved 3D printed tablet, there has been an increased interest in the application of this technology in drug delivery and biomedical applications. 3D printing brings us one step closer to personalized medicine, hence rendering the "one size fits all" concept in drug d...
Source: Journal of Pharmacy and Pharmaceutical Sciences - April 1, 2024 Category: Drugs & Pharmacology Authors: Alistair K C Chan Nehil Ranjitham Gopalakrishnan Yannick Leandre Traore Emmanuel A Ho Source Type: research

CB ‐0821, a novel CC chemokine receptor 5 (CCR5) inhibitor with improved binding efficacy proposed as anti‐HIV candidate: Computational and in vitro approach
In this study, CB-0821, identified from the ChemBridge library, emerged as a promising CCR5 inhibitor. Molecular dynamics simulations indicate comparable dynamic properties for CB-0821 and MVC. In silico comparisons with other CCR5 inhibitors emphasize CB-0821's superior binding affinity, positioning it as a potential lead compound. Evaluations of the dissociation constant (Ki) and absorption, distribution, metabolism, and excretion predictions suggest CB-0821 as a well-tolerated drug. Furthermore, the dose-dependent inhibition of CCR5 by CB-0821 in Peripheral blood mononuclear cells (PBMCs) (ranging from 10 to 200 nM) d...
Source: Biotechnology and Applied Biochemistry - April 1, 2024 Category: Biochemistry Authors: Ashish Kumar Tags: ORIGINAL ARTICLE Source Type: research

High systemic inflammation as a novel cardiovascular risk factor and target for anti-cytokine therapy: comment regarding the triglyceride glucose index
AbstractIn the last century, there has been more than enough research that proved the association of high lipid and glucose levels with cardiovascular disease, thus establishing the current well-known traditional cardiovascular risk factors such as dyslipidemia, diabetes, and metabolic syndrome. Hence, these cardiovascular risk factors are target therapy for glucose and lipid-lowering agents to prevent adverse cardiovascular events. However, despite controlling the lipid and glucose levels, some studies demonstrated the subclinical atherosclerosis suggesting that these cardiovascular risk factors alone cannot account for t...
Source: The International Journal of Cardiovascular Imaging - April 1, 2024 Category: Radiology Source Type: research

Unraveling the Potential of Water-Free Cyclosporine in Dry Eye Disease
In this issue of JAMA Ophthalmology, Peng and associates scrutinize the efficacy of SHR8028 (CyclASol 0.1% [Novaliq GmbH]), a water-free cyclosporine ophthalmic solution, 0.1%, used in the treatment of aqueous-deficient dry eye disease. SHR8028 uses a novel water-free vehicle perfluorobutylpentane (F4H5). Peng and associates conducted a rigorous randomized, double-masked, and vehicle-controlled phase 3 clinical trial in China that meticulously evaluates this innovative solution. A study of comparable but larger scale, namely the ESSENCE-2 randomized clinical trial, was piloted in the United States and published in JAMA Oph...
Source: JAMA Ophthalmology - April 1, 2024 Category: Opthalmology Source Type: research

Cabozantinib Response in a Patient With NSCLC Harboring Both MET Exon 14 Skipping Mutation and Secondary RET Fusion: A Case Report
JTO Clin Res Rep. 2024 Feb 7;5(4):100647. doi: 10.1016/j.jtocrr.2024.100647. eCollection 2024 Apr.ABSTRACTMET exon 14 skipping mutation has emerged as a new oncogenic driver in NSCLC with available targeted therapies, including Food and Drug Administration-approved inhibitors capmatinib and tepotinib. Potential resistance mechanisms are beginning to be described and include several on-target and off-target mutations. Here, we report an emergent secondary RET fusion in a patient with a primary MET exon 14 skipping mutation that progressed on capmatinib after the initial response. Subsequently, this patient received both a R...
Source: Cell Research - March 29, 2024 Category: Cytology Authors: Carlos Torrado Jamie Feng Elizabeth Faour Natasha B Leighl Source Type: research

Cabozantinib Response in a Patient With NSCLC Harboring Both MET Exon 14 Skipping Mutation and Secondary RET Fusion: A Case Report
JTO Clin Res Rep. 2024 Feb 7;5(4):100647. doi: 10.1016/j.jtocrr.2024.100647. eCollection 2024 Apr.ABSTRACTMET exon 14 skipping mutation has emerged as a new oncogenic driver in NSCLC with available targeted therapies, including Food and Drug Administration-approved inhibitors capmatinib and tepotinib. Potential resistance mechanisms are beginning to be described and include several on-target and off-target mutations. Here, we report an emergent secondary RET fusion in a patient with a primary MET exon 14 skipping mutation that progressed on capmatinib after the initial response. Subsequently, this patient received both a R...
Source: Clinical Lung Cancer - March 29, 2024 Category: Cancer & Oncology Authors: Carlos Torrado Jamie Feng Elizabeth Faour Natasha B Leighl Source Type: research

Progression-free survival estimates are shaped by specific censoring rules: Implications for PFS as an endpoint in cancer randomized trials
Eur J Cancer. 2024 Mar 20;202:114022. doi: 10.1016/j.ejca.2024.114022. Online ahead of print.ABSTRACTKaplan-Meier analysis hinges on the assumption that patients who are censored- lost to follow-up, or only recently enrolled on the study- are no different, on average, than patients who are followed. As such, censoring these patients- omitting their future information and taking the average of those who were followed- should not dramatically change the overall estimate. Yet, in a recent clinical trial, two sets of censoring rules- one favored by trialists and one favored by the US Food and Drug Administration- were applied ...
Source: Cancer Control - March 28, 2024 Category: Cancer & Oncology Authors: Vadim Lesan Timoth ée Olivier Vinay Prasad Source Type: research