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  • ||||||||||  Nplate (romiplostim) / Amgen
    Journal:  2023 Annual Meeting Abstract 178791 retraction. (Pubmed Central) -  Dec 12, 2024   
    The generic plerixafor produced comparable cumulative collection yields and early engraftment outcomes as Mozobil, but fewer doses and collection days were needed to reach collection goal. No abstract available
  • ||||||||||  Imlygic (talimogene laherparepvec) / Amgen
    Review, Journal, Metastases:  Advances in the management of regionally metastatic melanoma. (Pubmed Central) -  Dec 11, 2024   
    There has been significant progress in recent years with intralesional agents such as Talimogene laherparepvec (T-VEC), PV-10 and TAVOkinase/electrocorporation as well as advances in infusional therapies such as percutaneous hepatic perfusion (PHP) for hepatic metastasis of ocular melanoma. This review evaluates advances in intralesional and infusional therapies for melanoma while limiting discussion to those therapies currently approved and on trial.
  • ||||||||||  Ibrance (palbociclib) / Pfizer
    Journal:  Loss of Cdkn1a protects against MASLD alone or with alcohol intake by preserving lipid homeostasis. (Pubmed Central) -  Dec 11, 2024   
    Interestingly, in this study we found that Cdkn1a deletion protected against preclinical SLD by promoting fatty acid oxidation and preventing free fatty acid uptake and de novo lipogenesis, via the AMPK-SIRT3 axis. Translationally, Cdkn1a expression was found to be directly correlated with increased severity of NAFLD Activity Score (NAS) and fibrosis in SLD patients, and therefore, CDKN1A might be used potential theragnostic target for the treatment of metabolically induced SLD, with and without alcohol consumption.
  • ||||||||||  Repatha (evolocumab) / Amgen, Astellas
    Trial completion date, Trial primary completion date:  Mechanistic Clinical Trial of PCSK9 Inhibition for AAA (clinicaltrials.gov) -  Dec 11, 2024   
    P1,  N=44, Not yet recruiting, 
    Translationally, Cdkn1a expression was found to be directly correlated with increased severity of NAFLD Activity Score (NAS) and fibrosis in SLD patients, and therefore, CDKN1A might be used potential theragnostic target for the treatment of metabolically induced SLD, with and without alcohol consumption. Trial completion date: Nov 2028 --> Jan 2028 | Trial primary completion date: Nov 2028 --> Jan 2028
  • ||||||||||  ivabradine / Generic mfg.
    Review, Journal:  Reassessing Ivabradine: Potential Benefits and Risks in Atrial Fibrillation Therapy. (Pubmed Central) -  Dec 10, 2024   
    While ivabradine demonstrates promise as a therapeutic option for rate control in patients with AF, its use is accompanied by a notable risk of new-onset AF. Further studies should focus on optimal dosing strategies and long-term outcomes of ivabradine treatment in AF management.
  • ||||||||||  Tepezza (teprotumumab-trbw) / Roche, Amgen
    Clinical, Journal:  Surgical Timing for Patients with Thyroid Eye Disease Treated with Teprotumumab: A Collaborative Multicenter Study. (Pubmed Central) -  Dec 10, 2024   
    On the basis of our findings, clinicians can select suitable CDK4/6 inhibitors for patients by conducting thorough clinical evaluations. Our study suggests that while the rate of regression may not differ significantly, the severity, clinical impact, and need for additional surgery might be more pronounced for patients who have surgery more than 6 months after their last teprotumumab dose.
  • ||||||||||  Stivarga (regorafenib) / Bayer
    Trial completion, Trial completion date:  EREMISS: Phase II Study of Regorafenib as Maintenance Therapy (clinicaltrials.gov) -  Dec 10, 2024   
    P2,  N=127, Completed, 
    This paper focuses on adagrasib, the second KRAS p.G12C inhibitor to obtain regulatory approval by the FDA and describes the details on its study design, development and current place in therapy. Active, not recruiting --> Completed | Trial completion date: Mar 2025 --> Sep 2024
  • ||||||||||  Journal:  Reactivation of MAPK-SOX2 pathway confers ferroptosis sensitivity in KRASG12C inhibitor resistant tumors. (Pubmed Central) -  Dec 9, 2024   
    The clinical success of KRASG12C inhibitors (G12Ci) including AMG510 and MRTX849 is limited by the eventual development of acquired resistance...We found the ferroptosis inducers including sorafenib and lapatinib stood out with an obvious growth inhibition in the G12Ci resistant cells...Ferroptosis induced by sulfasalazine (SAS) achieved obvious inhibition on the tumor growth of xenografts derived from AMG510-resistant KRASG12C-mutant cells. Collectively, our results suggest a novel therapeutic strategy to treat patients bearing G12Ci resistant cancers with ferroptosis inducers.
  • ||||||||||  Vectibix (panitumumab) / Amgen
    P4 data, Journal, Adverse events, Real-world evidence, Real-world:  Post-marketing safety of panitumumab: a real-world pharmacovigilance study. (Pubmed Central) -  Dec 9, 2024   
    Ileus was highlighted as a novel ADR in gastrointestinal disorders, with no significant age or sex differences. This study identified new signals of ADR associated with panitumumab, providing valuable information for the clinical use of panitumumab.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    Journal:  Blinatumomab in Standard-Risk B-Cell Acute Lymphoblastic Leukemia in Children. (Pubmed Central) -  Dec 9, 2024   
    P3
    Adding blinatumomab to combination chemotherapy in patients with newly diagnosed childhood standard-risk B-cell ALL of average or high risk of relapse significantly improved disease-free survival. (Funded by the National Institutes of Health and others; AALL1731 ClinicalTrials.gov number, NCT03914625.).
  • ||||||||||  Tepezza (teprotumumab-trbw) / Roche, Amgen
    Review, Journal:  Teprotumumab versus intravenous methylprednisolone in thyroid eye disease: A systematic review. (Pubmed Central) -  Dec 9, 2024   
    This systematic review provides an overview of the existing treatment options using monoclonal antibody - teprotumumab and IVMP in TED patients. The overall assessment provides a finding that antibody - teprotumumab is is a good choice compared to conventional IVMP for providing better outcomes in patients with TED.
  • ||||||||||  Journal:  Drug-induced hearing disorders: a disproportionality analysis of the FAERS database. (Pubmed Central) -  Dec 9, 2024   
    The top five drugs for new signal strength are pancuronium (n = 13, ROR 67.57, PRR 53.61, IC5.74, EBGM 53.06), paromomycin (n = 6, ROR 46.3, PRR 39.33, IC5.30, EBGM 39.33), tafamidis (n = 300, ROR 14.90, PRR 14.13, IC3.82, EBGM 14.07), vildagliptin/metformin (n = 83, ROR 11.47, PRR 11.02, IC3.46, EBGM 11.01), and atorvastatin calcium/ezetimibe (n = 6, ROR 10.76, PRR 10.36, IC3.37, EBGM 10.36). Our study covered 20
  • ||||||||||  Enbrel (etanercept) / Pfizer, Amgen
    Retrospective data, Review, Journal:  Risk of Inflammatory Central Nervous System Diseases After Tumor Necrosis Factor-Inhibitor Treatment for Autoimmune Diseases: A Systematic Review and Meta-Analysis. (Pubmed Central) -  Dec 9, 2024   
    Secondary analyses revealed a similar risk of inflammatory CNS diseases across different types of underlying autoimmune diseases (rheumatic diseases: RR, 1.36; 95% CI, 0.84-2.21; inflammatory bowel disease 1.49; 95% CI, 0.93-2.40; P for subgroup?=?.74) and TNF inhibitors (anti-TNF monoclonal antibodies vs etanercept: RR, 1.04; 95% CI, 0.93-1.15; I2, 0%). Compared to conventional therapies, exposure to TNF inhibitors was associated with a 36% increased risk of inflammatory CNS diseases, irrespective of background autoimmune disease or TNF inhibitor type.
  • ||||||||||  Ibrance (palbociclib) / Pfizer
    Journal:  TFAP2C-DDR1 Axis Regulates Resistance to CDK4/6 Inhibitor in Breast Cancer. (Pubmed Central) -  Dec 8, 2024   
    Gene set enrichment analysis (GSEA) in the NeoPalAna trial demonstrated a significant enrichment of the TFAP2C-DDR1 gene set from patitens after palbociclib treatment, suggesting the possible activation of the TFAP2C-DDR1 axis following palbociclib exposure. Overall, this study provides crucial insights into the novel molecular landscape of palbociclib resistance in breast cancer, suggesting TFAP2C-DDR1 axis inhibition as a promising strategy to overcome resistance.
  • ||||||||||  Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin
    Acute Kidney Injury after Cardiac Surgery Is Associated with Increased Iron Deficiency Anemia Risk () -  Dec 7, 2024 - Abstract #ASH2024ASH_9735;    
    The increased 12-month risk of IDA and repeat cardiac surgery was mitigated with ESA treatment within 3 months with no increase in acute MI. Postoperative ESA use may protect against AKI-associated anemia without increased adverse events, representing an opportunity to improve health outcomes.
  • ||||||||||  Nplate (romiplostim) / Amgen, Promacta (eltrombopag) / Novartis
    Illness Perceptions and Heath Related Quality of Life in Patients with Primary Immune Thrombocytopenia () -  Dec 7, 2024 - Abstract #ASH2024ASH_9728;    
    A weak negative statistical correlation was identified between the IP total score and the EQ-VAS scale (r=-0.271, p=0.036).ConclusionThese preliminary findings suggest that IP may be linked to HRQoL in patients with ITP. Further investigation of these relationships is necessary to gain a deeper understanding of IP, its potential impact on patient outcomes, and the development of interventions aimed at improving patient HRQoL.
  • ||||||||||  Estimation of Eligibility and Response to Bispecific Antibody Therapy in US Patients with Lymphoma and Multiple Myeloma () -  Dec 7, 2024 - Abstract #ASH2024ASH_9653;    
    Excluding blinatumomab, all have gained accelerated approval through phase II trials to treat relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL); primarily diffuse large B-cell lymphoma (DLBCL and follicular lymphoma (FL), and R/R multiple myeloma (MM)...The calculated number of people eligible was multiplied by the overall response rate (ORR) reported in the trial that led to the bsAb approval for each year a therapy had an approval, using the highest calculated response, to estimate the population who would potentially benefit of these therapies.ResultsSix bsAbs were approved in the US since 2022 to treat NLH and MM : epcoritamab and glofitamab in 2023 to treat R/R DLBCL and other mature B-cell neoplasms, mosunetuzumab in 2022 and epcoritamab in 2024 to treat R/R grade 1-3A FL, and for MM, teclistamab in 2022, and elranatamab and talquetamab in 2023...Based on best available response rates from registration trials, we estimated that 9.6% and 10.5% newly diagnosed NHL and MM patients, respectively, would potentially benefit from bsAbs.ConclusionsEven though CR and ORR of bsAbs are high for highly pretreated patients, we found the percentage of newly diagnosed NHL and MM patients who would become potentially eligible and would respond to these therapies to be quite low (approximately only 1 out of 10). Even though these conclusions are driven by best-case scenario assumptions and have a risk of bias, they provide insights of the actual impact and reach of these newer therapies.
  • ||||||||||  Epogen (epoetin alfa) / Amgen, Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin
    Risks and Harms to Physicians Reporting Hematologic Adverse Drug Reactions (ADRs) to Health Authorities () -  Dec 7, 2024 - Abstract #ASH2024ASH_9597;    
    ADR findings resulted in drug removal (n = 7; Vioxx, Avandia, Bextra, Celebrex, Trasylol, Phenyl propanolamine, Hydroxy-ethyl starch), revised indications (n = 2) (Procrit, Aranesp 2007, 2008, 2010)) or 10-year delay in FDA-approval (n = 1) (Fereprox)...Pharmaceutical companies paid $600,000 (Fereprox) to $5.8 billion (Vioxx) in fines and settlements.Discussion : Twelve physicians experienced severe threats and/or harms after reporting hematologic-associated ADRs to Health Authorities and/or in major publications. We suggest physicians not sign secrecy agreements that might jeopardize public safety (as currently established by almost all US medical universities) and should partner with independent drug safety monitoring boards (DSMBs) on ADR evaluations to monitor safety concerns of drugs and medical devices.