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  • ||||||||||  Tezspire (tezepelumab-ekko) / AstraZeneca, Amgen
    Review, Journal:  Tezepelumab: a new option for the treatment of severe asthma (Pubmed Central) -  Nov 27, 2023   
    Therefore, in this review, we will show the clinical efficacy of tezepelumab in reducing the annual rate of exacerbations, improving lung function, and reducing bronchial hyperreactivity, regardless of the patient's baseline biomarker levels. Therefore, this new molecule is a highly effective therapeutic option for patients with severe asthma.
  • ||||||||||  Stivarga (regorafenib) / Bayer
    Clinical, P2 data, Journal:  Zinc supplementation decreased incidence of grade (Pubmed Central) -  Nov 27, 2023   
    P2
    Regorafenib, an oral multi-kinase inhibitor targeting VEGFR 1-3, PDGFR, cKIT, BRAF, and RET1, is approved for the treatment of metastatic colorectal cancer (mCRC) but commonly causes HFSR. This phase II randomized trial aimed to investigate whether zinc supplementation can reduce the severity of HFSR induced by regorafenib within the first 8 weeks of treatment (NCT03898102).
  • ||||||||||  barzolvolimab (CDX-0159) / Celldex, briquilimab (JSP191) / Jasper Therap, Xolair (omalizumab) / Roche, Novartis
    Review, Journal:  Inhibition of KIT for chronic urticaria: a status update on drugs in early clinical development. (Pubmed Central) -  Nov 27, 2023   
    There is a clear need for additional approved treatment options beyond H1 receptor antagonists and the anti-IgE monoclonal antibody (mAb), omalizumab...The prolonged depletion of mast cells over several weeks by barzolvolimab could effectively control urticarial symptoms...However, long-term safety data beyond 12?weeks are still lacking. The outcome of ongoing or planned clinical trials with several anti-KIT mAbs will need to demonstrate benefits compared to anti-IgE in CU or whether one approach is better suited for specific urticaria endotypes.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Journal:  Identification of Key Osteoporosis Genes Through Comparative Analysis of Men's and Women's Osteoblast Transcriptomes. (Pubmed Central) -  Nov 27, 2023   
    Denosumab treatment in postmenopausal women down-regulated 6 key genes, up-regulated T cell proportions, and down-regulated fibroblast proportion...We identified 9 key osteoporosis genes by comparing the transcriptome of osteoblasts in women and men. Our findings' clinical implications were confirmed by multi-omics data and qRT-PCR, and our study provides novel biomarkers and therapeutic targets for osteoporosis diagnosis and treatment.
  • ||||||||||  Wezlana (ustekinumab-auub) / Amgen
    Journal:  Analytical and Functional Similarity of the Biosimilar Candidate ABP (Pubmed Central) -  Nov 27, 2023   
    Exploratory safety analysis of PreCycle demonstrates for the first time in a randomized prospective trial that interactive autonomous eHealth-based support has a substantial favorable impact on the risk of SAEs and mitigates their severity for patients with advanced HR+/HER2- breast cancer on oral tumor therapy. Based on a comprehensive similarity assessment, ABP
  • ||||||||||  Review, Journal:  The Promise of PCSK9 and Lipoprotein(a) as Targets for Gene Silencing Therapies. (Pubmed Central) -  Nov 27, 2023   
    Further research is needed to examine whether gene silencing therapy could improve clinical outcomes in patients with elevated LDL and/or Lp(a) levels. Confirmation of the tolerability and cost-effectiveness of long-term inhibition of PCSK9 and Lp(a) with this approach is essential.
  • ||||||||||  Yondelis (trabectedin) / Otsuka, PharmaMar, Valeo Pharma, J&J, Neulasta (pegfilgrastim) / Amgen, Kyowa Kirin, Roche
    Retrospective data, Journal:  Impact of relative dose intensity of trabectedin with pegfilgrastim support: a single-centre retrospective study. (Pubmed Central) -  Nov 27, 2023   
    Moreover, we found no association between patients receiving ?4 trabectedin cycles and the use of pegfilgrastim. These results suggested that trabectedin dose delays or reductions should be considered before administering prophylactic pegfilgrastim.
  • ||||||||||  Vectibix (panitumumab) / Amgen, Stivarga (regorafenib) / Bayer
    Trial completion date, Trial primary completion date:  PARERE: PAnitumumab REchallenge Followed by REgorafenib Versus the Reverse Sequence (clinicaltrials.gov) -  Nov 27, 2023   
    P2,  N=214, Recruiting, 
    These results suggested that trabectedin dose delays or reductions should be considered before administering prophylactic pegfilgrastim. Trial completion date: Jun 2024 --> Jun 2025 | Trial primary completion date: Dec 2023 --> Dec 2024
  • ||||||||||  Vectibix (panitumumab) / Amgen
    Enrollment open, Enrollment change, Trial completion date, Trial primary completion date:  Panitumumab-IRDye800 in Diagnosing Participants with Malignant Glioma Undergoing Surgery (clinicaltrials.gov) -  Nov 27, 2023   
    P1/2,  N=22, Recruiting, 
    Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2023 --> Dec 2024 Active, not recruiting --> Recruiting | N=11 --> 22 | Trial completion date: May 2024 --> Dec 2024 | Trial primary completion date: Nov 2023 --> Nov 2024
  • ||||||||||  Bay11-7082 / Bayer, SB202190 / Amgen, SP600125 / BMS
    Preclinical, Journal:  Spring Viremia of Carp Virus Infection Induces Carp IL-10 Expression, Both In Vitro and In Vivo. (Pubmed Central) -  Nov 25, 2023   
    To our knowledge, this is the first time that a fish infection virus upregulated the host IL-10 expression through the JAK-STAT, NF-?B and p38MAPK pathways. Altogether, fish viruses may have a similar mechanism as human or other mammalian viruses to escape host immune surveillance and clearance.
  • ||||||||||  Imlygic (talimogene laherparepvec) / Amgen, Vyjuvek (beremagene geperpavec) / Krystal Biotech
    Preclinical, Journal, Gene therapy:  Attenuated Replication-Competent Herpes Simplex Virus Expressing an ECM-Modifying Transgene Hyaluronan Synthase 2 of Naked Mole Rat in Oncolytic Gene Therapy. (Pubmed Central) -  Nov 25, 2023   
    Another HSV-based drug, beremagene geperpavec (B-VEC), received approval in 2023 to treat the rare genetic disease dystrophic epidermolysis bullosa, and was also the first clinically approved HSV vector carrying an extracellular matrix (ECM)-modifying transgene...The viral replication, transgene expression and cytotoxic effect of the novel vector was studied in glioma cells. Our results show that an attenuated, replication-competent HSV vector expressing a foreign ECM-modifying transgene, namely HAS2, provides an effective tool to study and combat cancer in humans.
  • ||||||||||  Avastin (bevacizumab) / Roche, Erbitux (cetuximab) / Eli Lilly, EMD Serono, Vectibix (panitumumab) / Amgen, Takeda
    Review, Journal:  Colorectal Cancer: Disease Process, Current Treatment Options, and Future Perspectives. (Pubmed Central) -  Nov 25, 2023   
    However, many significant problems are still being experienced with these treatments, mainly off-target effects, toxic side effects, and the associated therapeutic failures of small molecular drugs and the rapid loss of efficacy of mAb therapies. Other novel delivery strategies continue to be investigated, including ligand-based targeting of CRC cells.
  • ||||||||||  Nplate (romiplostim) / Amgen, Kyowa Kirin, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
    Journal:  HLH and TET2 Mutation Presenting after First Cycle of CLL Treatment. (Pubmed Central) -  Nov 25, 2023   
    Laboratory evaluation revealed a pattern supportive of the clinical impression of HLH, while bone marrow biopsy showed persistent CLL, new reticulin fibrosis, megakaryocytic proliferation, and 32% mutated TET2, but no compelling morphologic evidence of hemophagocytosis. The patient recovered with dexamethasone and g-CSF support.
  • ||||||||||  Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
    Reimbursement, US reimbursement, Journal, Medicare:  The interruption of romosozumab treatment during COVID lockdown among US post-menopausal women enrolled in Medicare. (Pubmed Central) -  Nov 24, 2023   
    Compared to the pre-COVID period, the lockdown negatively impacted the continuity of romosozumab treatment among Medicare beneficiaries. Prioritizing in-time assistance for patients receiving a provider-administered parenteral therapy is critical when patients' in-person access to their provider is compromised.
  • ||||||||||  rocatinlimab (KHK4083) / Kyowa Kirin, Amgen
    Journal:  Efficacy of rocatinlimab for moderate-to-severe atopic dermatitis. (Pubmed Central) -  Nov 23, 2023   
    Prioritizing in-time assistance for patients receiving a provider-administered parenteral therapy is critical when patients' in-person access to their provider is compromised. No abstract available
  • ||||||||||  Omontys (peginesatide) / Affymax, Krystexxa (pegloticase) / Amgen
    Review, Journal:  A singlicate immunogenicity method to detect anti-polyethylene glycol antibodies: pre- and post-dose of PEGylated therapies. (Pubmed Central) -  Nov 22, 2023   
    Materials & The repetitive, linear PEG structure prevented the use of a bridging homogenous format, hence the requirement to use a solid phase extraction and acid dissociation assay coupled with the Meso Scale Discovery platform. Results & Using singlicate analysis, the method was validated to successfully detect APA pre- and postdose, with a crucial aspect of the method being the preparation of an appropriate negative control.
  • ||||||||||  Prolia (denosumab) / Amgen
    Trial primary completion date:  DEFENCE: Denosumab for High Risk SMM and SLiM CRAB Positive, Early Myeloma Patients (clinicaltrials.gov) -  Nov 22, 2023   
    P2,  N=8, Active, not recruiting, 
    Results & Using singlicate analysis, the method was validated to successfully detect APA pre- and postdose, with a crucial aspect of the method being the preparation of an appropriate negative control. Trial primary completion date: Jul 2024 --> Sep 2023
  • ||||||||||  Trial completion date, Trial initiation date, Trial primary completion date:  Application of N-of-1 Rheumatoid Arthritis (clinicaltrials.gov) -  Nov 22, 2023   
    P=N/A,  N=18, Not yet recruiting, 
    No abstract available Trial completion date: Oct 2025 --> Jan 2025 | Initiation date: Oct 2023 --> Jan 2024 | Trial primary completion date: Oct 2024 --> Jan 2025