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  • ||||||||||  Ibrance (palbociclib) / Pfizer, Jeselhy (pimitespib) / Otsuka
    Enrollment open, Metastases:  BrUOG 387: TAS-116 Plus Palbociclib in Breast and Rb-null Cancer (clinicaltrials.gov) -  Sep 14, 2023   
    P1,  N=27, Recruiting, 
    Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
  • ||||||||||  Neupogen (filgrastim) / Kyowa Kirin, Amgen
    Trial completion, Trial completion date, Gene therapy, Viral vector:  FANCOLEN-1: Lentiviral-mediated Gene Therapy of Fanconi Anemia Patients Subtype A (clinicaltrials.gov) -  Sep 14, 2023   
    P1/2,  N=9, Completed, 
    Not yet recruiting --> Recruiting Active, not recruiting --> Completed | Trial completion date: Apr 2022 --> Sep 2023
  • ||||||||||  Review Of Biologic Efficacy In Patients With Uncontrolled Asthma By Age At Asthma Onset (Monitor 15) -  Sep 14, 2023 - Abstract #ACAAI2023ACAAI_914;    
    Conclusion Among patients with moderate to severe, uncontrolled asthma, biologic efficacy by age at asthma onset aligned with biologic mechanisms of action and indications (allergic vs eosinophilic vs all phenotypes). These differences can help to identify patients more responsive to individual biologics, informing provider treatment decisions.
  • ||||||||||  Dupixent (dupilumab) / Sanofi, Regeneron, Tezspire (tezepelumab-ekko) / AstraZeneca, Amgen, Fasenra (benralizumab) / AstraZeneca
    Recent Real-World Biologic Utilization Among Adults With Severe Asthma: Data From The CHRONICLE Study (Monitor 14) -  Sep 14, 2023 - Abstract #ACAAI2023ACAAI_905;    
    Conclusion Biologic initiations and switching frequency among patients with SA in the US have changed over time as new biologic therapies have been approved. In the most recent time interval, tezepelumab and dupilumab were the most commonly initiated biologics.
  • ||||||||||  Tezspire (tezepelumab-ekko) / AstraZeneca, Amgen
    Timing Of Exacerbations With Tezepelumab Versus Placebo In Patients With And Without Symptomatic Perennial Allergy (Monitor 14) -  Sep 14, 2023 - Abstract #ACAAI2023ACAAI_904;    
    P3
    Reductions with tezepelumab compared with placebo were observed early in patients with and without confirmed symptomatic perennial allergy ( Figure ). Conclusion In patients with severe, uncontrolled asthma, tezepelumab treatment resulted in early and sustained reductions in the cumulative number of exacerbations compared with placebo, irrespective of confirmed symptomatic perennial allergy status.
  • ||||||||||  Tezspire (tezepelumab-ekko) / AstraZeneca, Amgen
    Tezepelumab Reduces All Key Inflammatory Biomarker Levels In Patients With Severe Allergic And Eosinophilic Asthma (Monitor 14) -  Sep 14, 2023 - Abstract #ACAAI2023ACAAI_901;    
    P2, P3
    Patients who received tezepelumab also experienced greater improvements in ACQ-6 and AQLQ(S)+12 scores than those who received placebo (least-squares mean difference [95% confidence interval]: ?0.37 [?0.58, ?0.15] and 0.38 [0.15, 0.62], respectively). Conclusion Compared with placebo, tezepelumab reduced measured inflammatory biomarker levels and improved asthma control and health-related quality of life in patients with severe allergic and eosinophilic asthma.
  • ||||||||||  briquilimab (JSP191) / Jasper Therap
    Briquilimab, an anti-CD117 antibody, prevents passive systemic anaphylaxis in mice expressing chimeric human/mouse CD117 (Monitor 21) -  Sep 14, 2023 - Abstract #ACAAI2023ACAAI_873;    
    Notably, briquilimab treatment with a single 25 mg/kg dose two weeks before PSA challenge completely prevented anaphylactic response, suggesting a single high dose of briquilimab effectively blocks PSA response in hmCD117 mice (Figure 1). Conclusion This study provides early proof of concept that briquilimab may be a promising treatment option for mast cell-mediated disorders.
  • ||||||||||  Nplate (romiplostim) / Amgen, Kyowa Kirin
    Delayed Diagnosis Of Common Variable Immunodeficiency And Importance Of Multi-Specialty Collaboration (Monitor 07) -  Sep 14, 2023 - Abstract #ACAAI2023ACAAI_656;    
    Five years later, he developed autoimmune hemolytic anemia (AIHA) recalcitrant to treatment including prednisone, IVIG, cyclosporine, and mycophenolate...Despite the discovery of hypogammaglobulinemia, further evaluation including genetic testing was not obtained until 6 years later with additional complications sustained while awaiting treatment and diagnosis. For this reason, patients with treatment-resistant autoimmune cytopenias should undergo routine immunological screening and multidisciplinary collaboration when immunological testing is abnormal.
  • ||||||||||  Neupogen (filgrastim) / Kyowa Kirin, Amgen, Noxafil (posaconazole) / Merck (MSD), Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
    Severe Neutropenia Presenting as Oral Ulcerations Resolved with G-CSF (Monitor 06) -  Sep 14, 2023 - Abstract #ACAAI2023ACAAI_647;    
    Case Description A 64 yo F with mantle cell lymphoma diagnosed in 2019 s/p chemotherapy and auto SCT on rituximab maintenance presented with a four-month history of painful, severe relapsing oral ulcers with associated gingival inflammation...She was given amoxicillin, valtrex, and posaconazole with no resolution...She started filgrastim with significant improvement and later resolution of her oral ulcers...Discussion Neutropenia is commonly seen in patients being evaluated for an immunodeficiency. With associated oral ulcerations, immunologists should consider neutropenia as a diagnosis as treatment can significantly improve patients
  • ||||||||||  Neulasta (pegfilgrastim) / Amgen, Kyowa Kirin, Roche
    Report of a Successful Subcutaneous Desensitization Protocol to Pegfilgrastim (Monitor 03) -  Sep 14, 2023 - Abstract #ACAAI2023ACAAI_599;    
    Case Description A 36-year-old woman diagnosed with breast cancer was treated with paclitaxel?+?carboplatin every two weeks in conjunction with pegfilgrastim...However, 18 hours after the second desensitization, the patient developed diffuse delayed hives that resolved with cetirizine 20 mg q12 for 2 days...Clinicians must be aware of this possibility and of the options on how to proceed, such as a desensitization. Although our patient developed urticaria 18 hours after the second desensitization, it was mild and responded promptly to antihistamines.
  • ||||||||||  Neulasta (pegfilgrastim) / Amgen, Kyowa Kirin, Roche
    Delayed-Type Hypersensitivity Reaction Following Pegfilgrastim Exposure (Monitor 02) -  Sep 14, 2023 - Abstract #ACAAI2023ACAAI_576;    
    Case Description A 76-year-old male with a history of pancreatic neuroendocrine carcinoma on carboplatin, etoposide plus pegfilgrastim presented to the emergency department for progressive rash and hypotension...However, his history, the prolonged time course, and especially the delayed recurrence on subsequent IV challenge demonstrate a delayed-type hypersensitivity response. This type of reaction is consistent with either direct antigen presentation to skin-homing cytotoxic lymphocytes, but we cannot rule out direct covalent binding of the pegfilgrastim to MHC class I antigens.
  • ||||||||||  Neupogen (filgrastim) / Kyowa Kirin, Amgen, Nivestym (filgrastim-aafi) / Pfizer
    Safe Administration of GCSF after Graded Challenge in Patient with Delayed Cutaneous Drug Hypersensitivity Reaction (Monitor 02) -  Sep 14, 2023 - Abstract #ACAAI2023ACAAI_573;    
    Subsequently, she began receiving low-dose SC filgrastim-aafi, due to insurance coverage restrictions...Despite receiving 2 doses of diphenhydramine, the rash persisted for 24 hours...She tolerated 0.5 mcg/kg of SC filgrastim (after pretreatment with cetirizine) in the office the next day...Discussion Delayed cutaneous drug hypersensitivity reactions frequently have a non-IgE-mediated mechanism. In cases with mild symptoms, a graded challenge may be implemented to safely administer the drug.
  • ||||||||||  Journal, Real-world evidence, Adherence, Real-world:  Real-World Data of Adherence and Drug Survival of Biologics in Treatment-Na (Pubmed Central) -  Sep 14, 2023   
    Real-world data, showing differences in drug survival of bDMARDs and tsDMARD, can also be used in the variety of considerations when choosing treatment. Future studies could separate patients with RA into subgroups, which would also account for potential drug survival differences and enable personalized therapy.
  • ||||||||||  Ibrance (palbociclib) / Pfizer
    Journal, Real-world evidence, Real-world:  Determinants of response to CDK4/6 inhibitors in the real-world setting. (Pubmed Central) -  Sep 13, 2023   
    P=N/A
    Together, these data suggest that there are distinct pathological and biological features of HR+/HER2- breast cancer associated with response to CDK4/6 inhibitors. Clinical trial registration number: NCT04526587.
  • ||||||||||  Review, Journal:  Novel Pharmacological Therapies for the Management of Hyperlipoproteinemia(a). (Pubmed Central) -  Sep 13, 2023   
    Traditional pharmacological interventions like niacin, statins, ezetimibe, aspirin, PCSK-9 inhibitors, mipomersen, estrogens and CETP inhibitors have not yet yielded satisfactory results...Pelacarsen is an antisense oligonucleotide, while olpasiran, LY3819469 and SLN360 are small interfering RNAs, all conjugated with a N-acetylgalactosamine molecule...The Lp(a) reduction achieved with novel RNA agents may exceed 95%. The results of ongoing and future clinical trials are eagerly anticipated, and it is hoped that guidelines for the tailored management of Lp(a) levels with these novel agents may not be far off.
  • ||||||||||  Zolinza (vorinostat) / Merck (MSD), ziftomenib (KO-539) / Kura Oncology, Kyowa Kirin, Blincyto (blinatumomab) / Astellas, Amgen
    Trial initiation date:  TINI 2: Total Therapy for Infants with Acute Lymphoblastic Leukemia II (clinicaltrials.gov) -  Sep 13, 2023   
    P1/2,  N=90, Not yet recruiting, 
    Trial primary completion date: Dec 2023 --> Jul 2023 Initiation date: Jul 2023 --> Nov 2023
  • ||||||||||  Lipaglyn (saroglitazar) / Zydus Lifesci, efruxifermin (AKR-001) / Amgen, lanifibranor (IVA337) / Inventiva
    Review, Journal:  Emerging therapeutic options for non-alcoholic fatty liver disease: A systematic review. (Pubmed Central) -  Sep 13, 2023   
    The data analyzed in this review showed clinically significant improvement in individual histological features of NAFLD in both animal and human trials for all four classes, as well as good safety profiles (P < 0.05). We believe this compilation of information will have positive clinical implications in obtaining an FDA-approved therapy for NAFLD.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Clinical, Journal, Real-world evidence, Real-world effectiveness, Real-world:  Real-World Effectiveness of Osteoporosis Medications in France: A Nationwide Cohort Study. (Pubmed Central) -  Sep 13, 2023   
    We believe this compilation of information will have positive clinical implications in obtaining an FDA-approved therapy for NAFLD. Data from the French national health insurance claims database (SNDS) were used to follow five cohorts of women aged ?55?years after initiating treatment for ?6?months with either denosumab, zoledronic acid, oral bisphosphonates, raloxifene, or teriparatide in 2014-2016.
  • ||||||||||  Krazati (adagrasib) / Mirati, Lumakras (sotorasib) / Amgen
    Review, Journal:  Targeted Therapies for Previously "Undruggable" KRAS-Mutated Non-Small Cell Lung Cancer: A Review of Sotorasib and Adagrasib. (Pubmed Central) -  Sep 13, 2023   
    Additional studies are required to further differentiate the safety and efficacy profiles of these 2 agents and identify their optimal place in therapy. Sotorasib and adagrasib demonstrated promising outcomes in targeting the constitutively active KRAS G12C oncogenic driver, underscoring the need for further research to optimize their therapeutic application in this high-risk population.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    Journal, Immune cell:  Blinatumomab differentially modulates peripheral blood and bone marrow immune cell repertoire: A Campus ALL study. (Pubmed Central) -  Sep 13, 2023   
    Of note, BM immune T-cell subsets showed a broader post-treatment subversion, including the modulation of markers associated with a T-cell-exhausted phenotype. In conclusion, our study indicates that blinatumomab differentially modulates the PB and BM immune cell repertoire, which may have relevant clinical implications in the therapeutic setting.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Review, Journal:  Investigation of Giant Cell Tumor of Bone and Tissue Engineering Approaches for the Treatment of Giant Cell Tumor of Bone. (Pubmed Central) -  Sep 12, 2023   
    The most often prescribed medication for GCTB is Denosumab, a RANKL (receptor activator of nuclear factor ?B ligand) inhibitor...This review summarizes and discusses GCTB, the disease, its cellular composition, various bone tumor models, and their properties and utilization in research. As a result, this study delves deep into in vitro testing, which is vital for scientists and physicians in various fields, including pharmacology, preclinical investigations, tissue engineering, and regenerative medicine.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
    Review, Journal:  Anti-sclerostin antibodies: a new frontier in fragility fractures treatment. (Pubmed Central) -  Sep 11, 2023   
    Clinical studies and guidelines suggest romosozumab as an initial drug in an ideal sequential approach from osteoanabolic to antiresorptive drugs. Some aspects of cardiovascular safety remain to be fully investigated, therefore its use in osteoporotic patients at high cardiovascular risk should be avoided until further data become available.