- |||||||||| Remicade (infliximab) / J&J, Renflexis (infliximab-abda) / Yuhan Corp, Biogen, Ewopharma, Samsung, Organon
Enrollment open, Trial initiation date: REMODEL-CD: Precise Infliximab Exposure and Pharmacodynamic Control (clinicaltrials.gov) - Jul 20, 2023 P2/3, N=180, Recruiting, Not yet recruiting --> Recruiting | Initiation date: Apr 2023 --> Jul 2023
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB, Rituxan (rituximab) / Roche
Enrollment open, Trial initiation date: Study of Pedi-cRIB: Mini-Hyper-CVD With Condensed Rituximab, Inotuzumab Ozogamicin and Blinatumomab (cRIB) for Relapsed Therapy for Pediatric With B-Cell Lineage Acute Lymphocytic Leukemia (clinicaltrials.gov) - Jul 20, 2023 P2, N=27, Recruiting, Not yet recruiting --> Recruiting | Initiation date: Apr 2023 --> Jul 2023 Not yet recruiting --> Recruiting | Initiation date: Apr 2024 --> Jul 2023
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Histopathological response to denosumab in giant cell tumours of bone - A review of 11 cases. (Pubmed Central) - Jul 20, 2023 There may be complete resolution or may be confused with benign or malignant lesions Rarely they may show sarcomatous transformation. It is imperative that the pathologist is aware of these changes to prevent diagnostic pitfalls as it poses therapeutic and prognostic implications.
- |||||||||| ivabradine / Generic mfg.
Journal: Effect of preoperative ivabradine on hemodynamics during elective off-pump CABG. (Pubmed Central) - Jul 20, 2023 It helps to maintain a lower HR during surgery and reduces the need for beta-blockers in the intraoperative period, a desirable and beneficial effect in situations where the use of beta-blockers may be potentially harmful. Further studies are needed to evaluate the beneficial effects of perioperative Ivabradine in patients with moderate-to-severe left ventricular dysfunction.
- |||||||||| Evolution of APPLE and Liver Cancer Management () - Jul 20, 2023 - Abstract #APPLE2023APPLE_228;
According to the Japanese nationwide registry of systemic therapy for HCC named Hepatoma Registry of Integrating and Aggregating Electric Health Records (HERITAGE), 6,400 treatment lines (sorafenib 2,319, lenvatinib 2,559, atezolizumab plus bevacizumab 768, regorafenib 406, ramucirumab 251, cabozantinib 71) have been identified in 4,307 cases treated between 2015 and 2022 (Asaoka 2023 ASCO- GI)...Real-world big data analytics using artificial intelligence (AI) may be a future promising direction. APPLE Association will continue to provide an ideal platform to facilitate the exchange of international and regional expertise in the research and management of liver cancer.
- |||||||||| Tezspire (tezepelumab-ekko) / AstraZeneca, Amgen
Journal, HEOR, Cost-effectiveness, Cost effectiveness: Cost-effectiveness of tezepelumab in Canada for severe asthma. (Pubmed Central) - Jul 19, 2023 P3 Tezepelumab provided additional life years and QALYs at additional cost compared with SoC in Canada. In addition, tezepelumab dominated (i.e., more effective, less costly) the other currently reimbursed biologics.
- |||||||||| Lumakras (sotorasib) / Amgen
Preclinical, Journal, Adverse events: Establishing the Role of Iridoids as Potential Kirsten Rat Sarcoma Viral Oncogene Homolog G12C Inhibitors Using Molecular Docking; Molecular Docking Simulation; Molecular Mechanics Poisson-Boltzmann Surface Area; Frontier Molecular Orbital Theory; Molecular Electrostatic Potential; and Absorption, Distribution, Metabolism, Excretion, and Toxicity Analysis. (Pubmed Central) - Jul 18, 2023 Of all the best-docked iridoids, Loganic acid passed Lipinski, Pfizer, and GSK filters with a similar toxicity profile to Sotorasib. Thus, if we consider these iridoids to be KRAS G12C inhibitors, they will be a boon to mankind.
- |||||||||| Ibrance (palbociclib) / Pfizer, Kisqali (ribociclib) / Novartis, Verzenio (abemaciclib) / Eli Lilly
Journal: Firing of Replication Origins Is Disturbed by a CDK4/6 Inhibitor in a pRb-Independent Manner. (Pubmed Central) - Jul 18, 2023 Our findings highlight hidden effects of palbociclib on the dynamics of DNA replication and of its cytotoxic consequences on cell viability in the absence of pRb. This study provides a potential therapeutic application of palbociclib in combination with other drugs to target genomic instability in pRB-deficient cancers.
- |||||||||| omecamtiv mecarbil (AMG 423) / Amgen, Servier, istaroxime (PST 2744) / Windtree Therap
Review, Journal: The current and future status of inotropes in heart failure management. (Pubmed Central) - Jul 17, 2023 Therefore, individualized and evidence-based treatment plans for patients who require inotropic support are necessary. Also, better quality data on the use of existing inotropes is imperative, while the development of newer and safer agents will lead to more effective management of patients with HF in the future.
- |||||||||| Ibrance (palbociclib) / Pfizer, Kisqali (ribociclib) / Novartis, Verzenio (abemaciclib) / Eli Lilly
Journal, Real-world evidence, Real-world, Metastases: Real-world analysis of the economic and therapeutic burden in advanced breast cancer patients in Italy. (Pubmed Central) - Jul 17, 2023 Dose reduction was associated with drug wastage in palbociclib and abemaciclib-treated patients, but not in ribociclib-treated ones. These findings might be helpful to policy decision-makers who, for healthcare strategies implementation, among several variables should consider the possible restraining of drug wastage.
- |||||||||| Praluent (alirocumab) / Sanofi, Regeneron, Leqvio (inclisiran) / Alnylam, Novartis, Repatha (evolocumab) / Amgen, Astellas
Review, Journal: Proprotein Convertase Subtilisin/Kexin Type 9 Inhibition: The Big Step Forward in Lipid Control. (Pubmed Central) - Jul 17, 2023 Additionally, several novel strategies to target PCSK9 are in development, including oral antibody, gene silencing, DNA base editing and vaccine therapies. This review highlights the efficacy, safety and clinical use of these various approaches in PCSK9 inhibition.
- |||||||||| Review, Journal, IO biomarker: How acute myeloid leukemia (AML) escapes from FMS-related tyrosine kinase 3 (FLT3) inhibitors? Still an overrated complication? (Pubmed Central) - Jul 17, 2023
A class of drugs, tyrosine-kinase inhibitors (TKI), targeting mutated FLT3, is already available with 1 and 2 generation molecules, but only midostaurin and gilteritinib are currently approved...Indeed, FLT3 inhibitors have significantly contributed to reducing the negative impact of FLT3 mutations on the prognosis of AML patients who are no longer considered at high risk by the European LeukemiaNet (ELN) 2022. Finally, several ongoing efforts to overcome resistance to FLT3-inhibitors will be presented: new generation FLT3 inhibitors in monotherapy or combined with standard chemotherapy, hypomethylating drugs, or IDH1/2 inhibitors, Bcl2 inhibitors; novel anti-human FLT3 monoclonal antibodies (e.g., FLT3/CD3 bispecific antibodies); FLT3-CAR T-cells; CDK4/6 kinase inhibitor (e.g., palbociclib).
- |||||||||| efruxifermin (AKR-001) / Amgen
Review, Journal: Efruxifermin, an investigational treatment for fibrotic or cirrhotic non-alcoholic steatohepatitis (NASH). (Pubmed Central) - Jul 17, 2023 While some other FGF-21 agonists (e.g. pegbelfermin) are currently not further investigated, available evidence supports the development of EFX as a promising anti-NASH drug in fibrotic and cirrhotic populations. However, antifibrotic efficacy, long-term safety and benefits (i.e. cardiovascular risk, decompensation events, disease progression, liver transplantation, mortality) remain to be determined.
- |||||||||| Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab-aooe) / Amgen, Novartis
Journal: Visual hypersensitivity in patients treated with anti-calcitonin gene-related peptide (receptor) monoclonal antibodies. (Pubmed Central) - Jul 17, 2023 However, antifibrotic efficacy, long-term safety and benefits (i.e. cardiovascular risk, decompensation events, disease progression, liver transplantation, mortality) remain to be determined. A decrease in visual hypersensitivity in patients with migraine after treatment with anti-CGRP (receptor) antibodies is positively associated with clinical response on migraine.
- |||||||||| Ibrance (palbociclib) / Pfizer
Journal: Epigenetic reprogramming of cell cycle genes by ACK1 promotes breast cancer resistance to CDK4/6 inhibitor. (Pubmed Central) - Jul 17, 2023 Hormone receptor-positive, HER2-negative advanced breast cancers exhibit high sensitivity to CDK4/6 inhibitors such as palbociclib...Overall, our pre-clinical data identifies activated ACK1 as an oncogene that epigenetically controls the cell cycle genes governing the G2/M transition in breast cancer cells. ACK1 inhibitor, (R)-9b could be a novel therapeutic option for the breast cancer patients that have developed resistance to CDK4/6 inhibitors.
- |||||||||| Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab-atto) / Amgen, Daiichi Sankyo
Review, Journal: TNF? inhibitor biosimilar associated with polychondritis. A case-based review. (Pubmed Central) - Jul 17, 2023 ACK1 inhibitor, (R)-9b could be a novel therapeutic option for the breast cancer patients that have developed resistance to CDK4/6 inhibitors. This report presents a 43-year-old man with psoriatic arthritis treated with ABP-501 (Amgevita), an adalimumab (ADA) biosimilar and who developed RP, 8
- |||||||||| Nplate (romiplostim) / Amgen, Kyowa Kirin, Promacta (eltrombopag) / Novartis, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Retrospective data, Journal, HEOR, Real-world evidence, Real-world: Early initiation of second-line therapy in primary immune thrombocytopenia: insights from real-world evidence. (Pubmed Central) - Jul 17, 2023 The AI-based approach showed promising results, however, future work is needed to validate the framework. To compare patients with primary immune thrombocytopenia (ITP) prescribed early (within 3
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