Simvastatin Preferentially Targets FLT3/ITD Acute Myeloid Leukemia by Inhibiting MEK/ERK and p38-MAPK Signaling Pathways
ConclusionsSimvastatin can selectively and effectively eradicateFLT3/ITD AML cells in vitro and in vivo, and its mechanism may be related to the disruption of the HMG-CoA reductase pathway and the downregulation of the MEK/ERK and p38-MAPK signaling pathways. (Source: Drugs in R&D)
Source: Drugs in R&D - October 17, 2023 Category: Drugs & Pharmacology Source Type: research
Analytical and Functional Similarity of the Biosimilar Candidate ABP 654 to Ustekinumab Reference Product
ConclusionsBased on a comprehensive similarity assessment, ABP 654 was found to be similar to ustekinumab RP, notwithstanding minor physicochemical differences that are not expected to have a clinically meaningful effect on safety or efficacy. (Source: Drugs in R&D)
Source: Drugs in R&D - October 13, 2023 Category: Drugs & Pharmacology Source Type: research
Effect of Tucatinib on Cardiac Repolarization in Healthy Volunteers
ConclusionTucatinib had no clinically relevant effects on studied ECG parameters. This study constitutes a clearly negative TQT study per ICH E14 guidance.Clinical Trial RegistrationThis trial (NCT03777761) was registered on 17 December 2018. (Source: Drugs in R&D)
Source: Drugs in R&D - September 26, 2023 Category: Drugs & Pharmacology Source Type: research
Looking into the Kinetics of NT-proBNP and sST2 Changes in Patients with Heart Failure Treated with Sacubitril/Valsartan: A Hint to Different Therapeutic Pathways
ConclusionThese findings suggest that, in patients with HF, sacubitril/valsartan effects on the cardiovascular system share a double pathway: a first, hemodynamic, faster pathway and a second, non-hemodynamic anti-fibrotic, delayed one. Both likely contribute to the sacubitril/valsartan benefits in HFrEF. (Source: Drugs in R&D)
Source: Drugs in R&D - September 13, 2023 Category: Drugs & Pharmacology Source Type: research
Pharmacovigilance Study of Infigratinib: A Safety Analysis of the FDA Adverse Event Reporting System
ConclusionsThese findings suggest that gastrointestinal and skin toxicities are the most common adverse reactions for infigratinib. It is important to recognize skin exfoliation and dehydration in clinical practice, as they are unexpected AEs. Additionally, our study indicates that infigratinib dose may correlate with an increased risk of AE severity, highlighting the need for dose adjustment of infigratinib when exposure to the drug is increased due to internal or external factors. (Source: Drugs in R&D)
Source: Drugs in R&D - September 12, 2023 Category: Drugs & Pharmacology Source Type: research
The Benefits and Risks of Switching from Fingolimod to Siponimod for the Treatment of Relapsing –Remitting and Secondary Progressive Multiple Sclerosis
AbstractMultiple sclerosis (MS) is a chronic neurodegenerative disease that affects the central nervous system (CNS). Currently, MS treatment is limited to several Food and Drug Administration (FDA)- and European Medicines Agency (EMA)-approved medications that slow disease progression by immunomodulatory action. Fingolimod and siponimod have similar mechanisms of action, and consequently, their therapeutic effects may be comparable. However, while fingolimod is mainly used for relapsing –remitting MS (RRMS), siponimod, according to EMA label, is recommended for active secondary progressive MS (SPMS). Clinicians and scie...
Source: Drugs in R&D - August 28, 2023 Category: Drugs & Pharmacology Source Type: research
Demonstration of Physicochemical and Functional Similarity of Biosimilar Adalimumab-aqvh to Adalimumab
ConclusionThe structural, functional, and stability data provide convincing evidence of biosimilarity between adalimumab-aqvh and the reference product, adalimumab. (Source: Drugs in R&D)
Source: Drugs in R&D - August 26, 2023 Category: Drugs & Pharmacology Source Type: research
In-Use Stability of SB12 (Eculizumab, Soliris Biosimilar) Diluted in Saline and Dextrose Infusion Solution after an Extended Storage Period
ConclusionsThe infusion stability of SB12 after extended storage (5 ± 3 °C for up to 3 months, then 30 ± 2 °C/65 ± 5% RH for 72 h) was demonstrated for longer periods and at higher temperatures than what is stated in the EU and US labels of the reference product. The physicochemical properties, biological activity, and subvisible particles of in-use SB12 diluted in 0.9% NaCl and 0.45% NaCl were maintained under the described conditions and for all tested containers. However, instability was observed for the diluted SB12 in 5% dextrose. These results may reduce the workload of clinical staff and minimize ...
Source: Drugs in R&D - August 22, 2023 Category: Drugs & Pharmacology Source Type: research
Tremor Induced by Cyclosporine, Tacrolimus, Sirolimus, or Everolimus: A Review of the Literature
AbstractCalcineurin inhibitors such as cyclosporine and tacrolimus are immunosuppressant drugs that are known to induce tremors. Non-calcineurin inhibitors such as sirolimus and everolimus have also reportedly been accompanied by tremors, albeit less likely. However, the prevalence rates reported in the literature are notably wide, and the risk profiles for these drug-induced tremors are less understood. We searched PubMed to extract data on the risk of tremors with these drugs when prescribed for various transplant and non-transplant indications. We ascertained whether the risk of drug-induced tremor is influenced by the ...
Source: Drugs in R&D - August 22, 2023 Category: Drugs & Pharmacology Source Type: research
Comparative Efficacy of Different Drugs for the Treatment of Dilated Cardiomyopathy: A Systematic Review and Network Meta-analysis
ConclusionA combination of different medications and conventional therapy may increase the clinical effectiveness of treating dilated cardiomyopathy. Beta-blockers, especially carvedilol, can improve ventricular remodeling, cardiac function, and clinical efficacy in patients with dilated cardiomyopathy (DCM). Hence, they can be used if patients tolerate them. If LVEF and HR do not meet the standard, ivabradine can also be used in combination with other treatments. However, since the quality and number of studies in our research were limited, large sample size, multi-center, and high-quality randomized controlled trials are...
Source: Drugs in R&D - August 9, 2023 Category: Drugs & Pharmacology Source Type: research
Risk of Hyponatremia after Tramadol/Acetaminophen Single-Pill Combination Therapy: A Real-World Study Based on the OMOP –CDM Database
ConclusionIn this real-world study, hyponatremia was more frequently observed in the TA than AA group, and in the TA –ER than TA–IR subgroup. Therefore, it is imperative to prescribe tramadol cautiously and closely monitor electrolyte levels. (Source: Drugs in R&D)
Source: Drugs in R&D - July 28, 2023 Category: Drugs & Pharmacology Source Type: research
Physicochemical and Functional Similarity Assessment Between Proposed Bevacizumab Biosimilar BAT1706 and Reference Bevacizumab
ConclusionOverall, this extensive comparability exercise demonstrated BAT1706 to match EU/US-bevacizumab in terms of all physicochemical and functional attributes assessed. (Source: Drugs in R&D)
Source: Drugs in R&D - July 22, 2023 Category: Drugs & Pharmacology Source Type: research
Biochemical Characterization of a New 10% IVIG Preparation [IgG Next Generation (BT595)/Yimmugo ®] Obtained from a Manufacturing Process Preserving IgA/IgM Potential of Human Plasma
ConclusionYimmugo® constitutes a new high quality IVIG preparation derived from a novel manufacturing process that takes advantage of the full therapeutic immunoglobulin potential of human plasma. (Source: Drugs in R&D)
Source: Drugs in R&D - July 19, 2023 Category: Drugs & Pharmacology Source Type: research
Efficacy and Safety of Apatinib in Patients with Recurrent Glioblastoma
ConclusionsApatinib might be effective in treating recurrent glioblastoma after chemoradiotherapy in terms of the overall response rate, but the efficacy is not durable and the clinical benefit is limited. The adverse effects of apatinib were acceptable.Clinical Trial RegistrationChiCTR-ONC-17013098, date of registration: 24 October, 2017. (Source: Drugs in R&D)
Source: Drugs in R&D - July 19, 2023 Category: Drugs & Pharmacology Source Type: research
Bioavailability of Melatonin after Administration of an Oral Prolonged-Release Tablet and an Immediate-Release Sublingual Spray in Healthy Male Volunteers
ConclusionsThe results suggest that the galenic forms containing melatonin assessed in this study are suitable for the treatment of certain sleep disorders such as sleep onset delay and transient nocturnal awakenings for the IR form and insomnia for the PR form.Trial RegistryRegistration number: NCT04574141. (Source: Drugs in R&D)
Source: Drugs in R&D - July 12, 2023 Category: Drugs & Pharmacology Source Type: research
