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  • ||||||||||  Ibrance (palbociclib) / Pfizer, Kisqali (ribociclib) / Novartis, Verzenio (abemaciclib) / Eli Lilly
    Journal, Adverse events:  A disproportionality analysis of CDK4/6 inhibitors in the FDA adverse event reporting system (FAERS). (Pubmed Central) -  Jan 3, 2025   
    The number of AE reports for CDK4/6 inhibitors was respectively 132,494 for palbociclib 56,151 for ribociclib, and 7,014 for abemaciclib. The corresponding numbers of AE signals were 319, 517, and 59, with the number of involved System Organ Class (SOC) being 23, 23, and 15, mainly involving blood and lymphatic system disorders, respiratory, thoracic and mediastinal disorders, hepatobiliary disorders, skin and subcutaneous tissue disorders, etc. CDK4/6 inhibitors could lead to pulmonary toxicity, myelosuppression, skin reactions, etc. Special attention should be paid to abemaciclib for interstitial lung disease (ILD), erythema multiforme, and thrombosis risk; ribociclib for cardiac toxicity, hepatotoxicity, and musculoskeletal toxicity; palbociclib for neurocognitive impairment and osteonecrosis of the jaw.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
    Journal, IO biomarker:  How I treat post-immunotherapy relapsed B-ALL. (Pubmed Central) -  Jan 3, 2025   
    We explore treatment modalities including CD19-CAR re-infusions, humanized CAR constructs, combinatorial strategies, and alternative antigen-targeted therapies, such as blinatumomab and inotuzumab. Challenges in diagnosis, particularly with antigen-escape, are addressed, highlighting the role of next-generation sequencing and multiparameter flow cytometry for myeloid marker monitoring.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    Journal:  How I Treat on Infant Acute Lymphoblastic Leukemia. (Pubmed Central) -  Jan 3, 2025   
    Of these, there is promising early data on the efficacy and tolerability of the bi-specific T-cell engager monoclonal antibody, blinatumomab, as well as the use of autologous and allogeneic chimeric antigen receptor T-cell therapy. We discuss how we can improve risk stratification and incorporate these new agents to replace the most toxic elements of currently deployed intensive chemotherapy schedules with their associated unacceptable toxicity.
  • ||||||||||  Rituxan (rituximab) / Roche
    Journal, Adverse events:  Safety of marketed biosimilar monoclonal antibody cancer treatments in the US: a disproportionality analysis using the food and drug administration adverse event reporting system (FAERS) database. (Pubmed Central) -  Jan 3, 2025   
    Significant AE reporting signals were identified: 1) death for biological rituximab, pruritus for biosimilar rituximab-pvvr, and infusion related reaction for biological rituximab and biosimilar rituximab-pvvr (significantly higher ROR for rituximab-pvvr than biological rituximab, p?<?.0001); 2) death for biological bevacizumab and biosimilar bevacizumab-bvzr (significantly higher ROR for bevacizumab-bvzr than biological bevacizumab, p?<?.0001), hypertension, platelet count decreased (PCD), and proteinuria for biological bevacizumab and biosimilar bevacizumab-awwb (significantly higher ROR of PCD for bevacizumab-awwb than originator bevacizumab, p?=?.001); and 3) rash for biosimilar trastuzumab-anns. Findings call for large, longitudinal studies to examine causality of certain AEs with rituximab-pvvr and bevacizumab biosimilars.
  • ||||||||||  Review, Journal:  An update on the pharmacotherapy of gout. (Pubmed Central) -  Jan 3, 2025   
    There are also emerging therapies in development. However, there is increasing personalization of treatment, adjusting pharmacotherapy depending on comorbidities, such as chronic kidney disease and ischemic heart disease, as well as patient preference.
  • ||||||||||  paclitaxel / Generic mfg., Stivarga (regorafenib) / Bayer
    Journal:  Ultrasmall solid lipid nanoparticles as a potential innovative delivery system for a drug combination against glioma. (Pubmed Central) -  Jan 3, 2025   
    Moreover, relevant in vivo evidence assessed the accumulation of solid lipid nanoparticles in the glioma site of the F98/Fischer rat model, without causing any off-target toxicity. Thus, promising results for glioma treatment were obtained with a technology characterized by safety and economy, allowing the perspective of successful scalability.
  • ||||||||||  Tavneos (avacopan) / Amgen
    Review, Journal:  Complement as a major mediator of ANCA vasculitis and a target for precision therapy. (Pubmed Central) -  Jan 3, 2025   
    While complement activation is undoubtedly involved in ANCA vasculitis pathogenesis, less clear is whether measuring complement activation markers can reliably assess disease activity, predict those who will benefit from complement-targeting therapy, or identify patients in stable remission and able to stop therapy. Better understanding the clinical implications of complement activation will shed more light on the utility of complement inhibition and facilitate precision medicine in ANCA vasculitis.
  • ||||||||||  Prolia (denosumab) / Amgen
    Trial completion:  A Study of Denosumab in Multiple Myeloma Patients with Renal Insufficiency (clinicaltrials.gov) -  Jan 3, 2025   
    P2,  N=55, Completed, 
    Trial completion date: Dec 2024 --> Jun 2027 | Trial primary completion date: Dec 2024 --> Jun 2027 Recruiting --> Completed
  • ||||||||||  Review, Journal:  Identifying Promising Immunomodulators for Type 1 Diabetes (T1D) and Islet Transplantation. (Pubmed Central) -  Dec 30, 2024   
    P, P1/2, P
    FDA-approved teplizumab for Stage 2 T1D is discussed along with other immunomodulators that have been tested in Phase 3 clinical trials or higher, including otelixizumab (another anti-CD3 monoclonal antibody), daclizumab (an anti-CD25 monoclonal antibody), ladarixin (CXCR1/2 inhibitor), and antithymocyte globulin (ATG)...Several immunomodulators involved in Phase 3 clinical studies of islet transplantation are also discussed, including alemtuzumab, basiliximab, etanercept, and reparixin, some already FDA-approved for other uses...This review provides background, mechanism of action, results of completed trials, and adverse effects as well as details regarding ongoing clinical trials for each of these immunomodulators. Trial Registration: ClinicalTrials.gov identifier: NCT03875729, NCT01030861, NCT00129259, NCT00385697, NCT01280682; NCT03929601, NCT04598893, NCT05757713, NCT00678886, NCT01123083, NCT00064714, NCT00468117, NCT04628481, NCT01106157, NCT02215200, NCT00331162, NCT00679042, NCT01220856, NCT01817959.
  • ||||||||||  Trial completion date, Trial primary completion date:  Panitumumab-IRDye800 to Detect Pediatric Neoplasms During Neurosurgical Procedures (clinicaltrials.gov) -  Dec 27, 2024   
    P1/2,  N=12, Not yet recruiting, 
    Completed --> Terminated; Despite modifications, accrual was poor and the closed Trial completion date: Jan 2025 --> Jan 2026 | Trial primary completion date: Aug 2024 --> Aug 2025
  • ||||||||||  maridebart cafraglutide (AMG 133) / Amgen, Mounjaro (tirzepatide) / Eli Lilly
    Preclinical, Journal:  Glucose-dependent insulinotropic polypeptide receptor signaling alleviates gut inflammation in mice. (Pubmed Central) -  Dec 26, 2024   
    The clinical development of GIP receptor (GIPR)-GLP-1 receptor (GLP-1R) multi-agonists exemplified by tirzepatide and emerging GIPR antagonist-GLP-1R agonist therapeutics such as maritide is increasing interest in the extra-pancreatic actions of incretin therapies...Here, using gain and loss of function studies, we show that GIP alleviates 5-fluorouracil (5FU)-induced gut inflammation, whereas genetic deletion of Gipr exacerbates the proinflammatory response to 5FU in the murine small bowel (SB)...Within the gut, Gipr was localized to non-immune cells, specifically stromal CD146+ cells. Hence, the extra-pancreatic actions of GIPR signaling extend to the attenuation of gut inflammation, findings with potential translational relevance for clinical strategies modulating GIPR action in people with type 2 diabetes or obesity.
  • ||||||||||  Ibrance (palbociclib) / Pfizer
    Journal:  Skin Metastasis From Solid Tumors: Is Targeted Therapy Making an Impact? (Pubmed Central) -  Dec 26, 2024   
    Here, we present two cases of solid tumors with skin metastases that had a good response to targeted systemic therapy. This case report also discusses the various modes of presentation and the therapeutic options for metastatic cutaneous lesions from solid tumors.
  • ||||||||||  linsitinib (ASP7487) / Sling Therap
    Journal:  Linsitinib inhibits proliferation and induces apoptosis of both IGF-1R and TSH-R expressing cells. (Pubmed Central) -  Dec 26, 2024   
    In addition, in the TSH-R-Ab blocking bioassay, Linsitinib and the tested compounds demonstrated strong inhibition across all ten dilutions (100%). Linsitinib effectively induces apoptosis and inhibits proliferation of both IGF-1R and TSH-R expressing target cells, therefore demonstrating its therapeutic potential to block the reported crosstalk of the two mediators in autoimmune TED.
  • ||||||||||  Repatha (evolocumab) / Amgen, Astellas
    Clinical, Journal:  Long-Term Cognitive Safety of Achieving Very Low LDL Cholesterol with Evolocumab. (Pubmed Central) -  Dec 24, 2024   
    Exposure to very low levels of LDL cholesterol, achieved via PCSK9 inhibition and statin therapy, was not associated with cognitive impairment through long-term follow-up. Further studies are needed to assess the generalizability to adults at higher risk of dementia.
  • ||||||||||  Krazati (adagrasib) / BMS
    Journal:  Adagrasib in KRYSTAL-12 (Pubmed Central) -  Dec 24, 2024   
    However, these results fall short of the 6-month PFS benchmark that had seemed achievable from what had been seen in phase 1 and 2 trials, mirroring similarly disappointing results from the CodeBreaK 200 trial wherein sotorasib, the first-in-class KRAS G12C inhibitor, also failed to meet the 6-month benchmark also thought to be possible when examining earlier trials. These results raise the question of adagrasib's true value in the second-line treatment setting and compel us to explore more potent novel therapies, combination therapies, and more as we seek to break the 6-month PFS barrier in the treatment of KRAS G12C mutant NSCLC.
  • ||||||||||  Enbrel (etanercept) / Pfizer, Amgen
    Journal:  Stevens-Johnson syndrome with overlapping features of DRESS syndrome: A report of two cases. (Pubmed Central) -  Dec 23, 2024   
    Despite the use of cyclosporine and repeated doses of etanercept, both cases evolved to have significant edema of the face and extremities, palmar and plantar involvement, and rapid response to systemic corticosteroids, which is more in-keeping with drug reaction with eosinophilia and systemic symptoms. We aim to help clinicians gain awareness of Stevens-Johnson syndrome/drug reaction with eosinophilia and systemic symptoms overlap which may aid diagnosis and guide treatment.
  • ||||||||||  Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
    Review, Journal:  Advancements in the Management of Fragility Fractures in Orthopaedic Patients. (Pubmed Central) -  Dec 23, 2024   
    Advancements in medical therapy include romosozumab, recommended by the National Institute for Health and Care Excellence guidance in patients with imminent fracture risk, which improves overall bone mineral density...The surgical approach to fragility fractures has undergone major advancements over the past 20 years, with developments such as polyaxial locking and far cortical locking systems that achieve secondary bone healing, as well as cement augmented screw fixation to provide stable fixation in osteoporotic bone. The development of minimally invasive surgical approaches has led to improved periosteal blood flow around a fracture site, as well as reduced operating time, hospital stay, and time to pain-free weight-bearing.
  • ||||||||||  Enbrel (etanercept) / Pfizer, Amgen, Humira (adalimumab) / AbbVie
    Review, Journal:  Effectiveness of Anti-tumor Necrosis Factor Drugs on Hidradenitis Suppurativa: A Systematic Review. (Pubmed Central) -  Dec 23, 2024   
    This has led to the use of biologic agents, most notably adalimumab, which is currently the only FDA-approved therapy for HS...This review was conducted to thoroughly assess the effectiveness of these therapies, offering a detailed analysis to inform future research and clinical practice. The objective is to determine whether anti-TNF drugs continue to be a strong treatment option or if newer therapies might lead to better outcomes for patients.
  • ||||||||||  Stivarga (regorafenib) / Bayer, Tecentriq (atezolizumab) / Roche
    PK/PD data, Review, Journal:  Sex differences in the pharmacokinetics of anticancer drugs: a systematic review. (Pubmed Central) -  Dec 22, 2024   
    Additional sex-based PK-pharmacodynamic analyses are recommended during dose optimisation and are to be conducted in line with the FDA Project Optimus guidance. They should be reported even if no association between the patients' sex and the activity and/or toxicity of an anticancer drug has been identified.