- |||||||||| Shingrix (zoster vaccine recombinant adjuvanted) / GSK, Japan Vaccine
CONTEMPORARY INTEGRATED VACCINE SAFETY SURVEILLANCE FOR THE IMPLEMENTATION OF NEW RESPIRATORY SYNCYTIAL VIRUS VACCINES AND MONOCLONALS (STATION 1) - Apr 2, 2024 - Abstract #ESPID2024ESPID_516;
Results We leverage our experience with COVID, MPox and Shingrix vaccine introductions to the Australian population to exemplify the advantages of our integrated surveillance platform and demonstrate the effectiveness of utilising electronic health data to complement traditional spontaneous AEFI reporting...Conclusions/Learning Points In conclusion, while the introduction of RSV preventive medicines offers a beacon of hope in reducing the global burden of RSV-associated diseases, rigorous and vigilant safety surveillance remains imperative. By harnessing innovative surveillance methodologies and promoting transparent communication, we can navigate the complexities of vaccine safety, safeguarding public health and fostering confidence in immunization strategies.
- |||||||||| Varubi (rolapitant oral) / TerSera Therap, GSK
Journal: Rolapitant treats lung cancer by targeting deubiquitinase OTUD3. (Pubmed Central) - Apr 1, 2024
BAs are promising agents for CRSwNP patients with frequent exacerbations and multiple surgeries. In summary, the present study identifies Rolapitant as a novel inhibitor of deubiquitinase OTUD3 and establishes that the OTUD3-GRP78 axis is a potential therapeutic target for lung cancer.
- |||||||||| Prolia (denosumab) / Amgen
Observational data, Journal: Long-term effects of denosumab on bone mineral density and turnover markers in patients undergoing hemodialysis. (Pubmed Central) - Apr 1, 2024
In summary, the present study identifies Rolapitant as a novel inhibitor of deubiquitinase OTUD3 and establishes that the OTUD3-GRP78 axis is a potential therapeutic target for lung cancer. The study showed long-term suppression of TRACP-5b and BAP levels and sustaining BMD after denosumab administration over an extended period in patients undergoing hemodialysis.
- |||||||||| GSK2606414 / GSK, Institute of Cancer Research, Dartmouth College
Journal: Neuromuscular organoids model spinal neuromuscular pathologies in C9orf72 amyotrophic lateral sclerosis. (Pubmed Central) - Apr 1, 2024
Acute treatment with the unfolded protein response inhibitor GSK2606414 increased the glutamatergic muscular contraction 2-fold and reduced the dipeptide repeat protein aggregation and autophagy. This study provides an organoid system for spinal neuromuscular pathologies in ALS and its application for drug testing.
- |||||||||| Review, Journal: A Neuroanatomic and Pathophysiologic Framework for Novel Pharmacological Approaches to the Treatment of Post-traumatic Stress Disorder. (Pubmed Central) - Apr 1, 2024
Indeed, investigations and drug development are proceeding in a number of these alternative, non-serotonergic pathways in an effort to improve the management of PTSD. In this manuscript, the authors introduce novel and emerging treatments for PTSD, including drugs in various stages of development and clinical testing (BI 1358894, BNC-210, PRAX-114, JZP-150, LU AG06466, NYV-783, PH-94B, SRX246, TNX-102), established agents and known compounds being investigated for their utility in PTSD (brexpiprazole, cannabidiol, doxasoin, ganaxolone, intranasal neuropeptide Y, intranasal oxytocin, tianeptine oxalate, verucerfont), and emerging psychedelic interventions (ketamine, MDMA-assisted psychotherapy, psilocybin-assisted psychotherapy), with an aim to examine and integrate these agents into the underlying pathophysiological frameworks of trauma-related disorders.
- |||||||||| Prolia (denosumab) / Amgen
Journal: Cancer risk in patients treated with denosumab compared with alendronate: A population-based cohort study. (Pubmed Central) - Apr 1, 2024
In this manuscript, the authors introduce novel and emerging treatments for PTSD, including drugs in various stages of development and clinical testing (BI 1358894, BNC-210, PRAX-114, JZP-150, LU AG06466, NYV-783, PH-94B, SRX246, TNX-102), established agents and known compounds being investigated for their utility in PTSD (brexpiprazole, cannabidiol, doxasoin, ganaxolone, intranasal neuropeptide Y, intranasal oxytocin, tianeptine oxalate, verucerfont), and emerging psychedelic interventions (ketamine, MDMA-assisted psychotherapy, psilocybin-assisted psychotherapy), with an aim to examine and integrate these agents into the underlying pathophysiological frameworks of trauma-related disorders. There was no difference in the risk of cancer following treatment with denosumab compared to treatment with alendronate assessed after a short follow-up of 3
- |||||||||| Arexvy (respiratory syncytial virus vaccine, adjuvanted) / GSK
Journal: Vaccines against respiratory syncytial virus. (Pubmed Central) - Mar 31, 2024
In addition, Abrysvo is approved for use during pregnancy to protect infants from RSV-associated lower respiratory tract infection. Currently, there is no national recommendation for the use of the vaccines, but vaccination of elderly at highest risk of severe RSV infection should be considered in a shared clinical decision making.
- |||||||||| Prolia (denosumab) / Amgen
Review, Journal: Medical Management for Fracture Prevention in Children with Osteogenesis Imperfecta. (Pubmed Central) - Mar 30, 2024
New therapies are undergoing clinical trials, and it is likely that one or more will receive marketing authorisation within the next three to five years. The long-term outcome from such interventions will need to be studied carefully well beyond the period over which the clinical trials are conducted, and a consistent approach to the collection of data in this regard will be needed as a major collaborative effort.
- |||||||||| GSK3390107 / GSK
P1 data, Journal: Heterologous cAd3-Ebola and MVA-EbolaZ vaccines are safe and immunogenic in US and Uganda phase 1/1b trials. (Pubmed Central) - Mar 30, 2024
P1, P1b
We investigated the safety and immunogenicity of a heterologous prime-boost regimen involving a chimpanzee adenovirus 3 vectored Ebola vaccine [either monovalent (cAd3-EBOZ) or bivalent (cAd3-EBO)] prime followed by a recombinant modified vaccinia virus Ankara EBOV vaccine (MVA-EbolaZ) boost in two phase 1/1b randomized open-label clinical trials in healthy adults in the United States (US) and Uganda (UG)...Different prime-boost intervals impacted the magnitude of humoral and cellular immune responses. The results from these studies demonstrate promising implications for use of these vaccines in both prophylactic and outbreak settings.
- |||||||||| Shingrix (zoster vaccine recombinant adjuvanted) / GSK, Japan Vaccine
Evolving IBD Care - A Deep Dive into Shingles Prevention for IBD Patients (Room C) - Mar 30, 2024 - Abstract #IMKASID2024IMKASID_43;
Recently, with the introduction of the RZV and its subsequent domestic availability, it has become possible for IBD patients on immunosuppressive therapy to receive the shingles vaccine. This development represents a significant step forward in the comprehensive care of patients with IBD, offering them protection against a potentially serious infection for which they are at increased risk due to their underlying disease and treatment regimen.
- |||||||||| Journal, Real-world evidence, Real-world: Comparison of the Efficacy of Anti-Obesity Medications in Real-World Practice. (Pubmed Central) - Mar 29, 2024
All the AOMs were effective at inducing and maintaining weight loss, in the absence of significant changes in muscle mass, over a 6 month period, and the short-term use of phentermine and the long-term use of phentermine/topiramate or liraglutide would be practical choices for the treatment of obesity. However, further, large-scale studies are necessary to confirm these findings.
- |||||||||| Prolia (denosumab) / Amgen, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Review, Journal: Anti-osteoporotic treatments in the era of non-alcoholic fatty liver disease: friend or foe. (Pubmed Central) - Mar 29, 2024
Since these two chronic diseases frequently co-exist, there are data suggesting that anti-osteoporosis treatments may affect NAFLD progression by impacting on its pathogenetic mechanisms. In the present review, we present on overview of the current understanding of the liver-bone cross talk and summarize the experimental and clinical evidence correlating NAFLD and osteoporosis, focusing on the possible effects of anti-osteoporotic drugs on NAFLD.
- |||||||||| Prolia (denosumab) / Amgen, Kadcyla (ado-trastuzumab emtansine) / Roche
Journal, Metastases: Recurrent severe hypocalcemia following chemotherapy regimen changes in advanced breast cancer: two case reports. (Pubmed Central) - Mar 29, 2024
It is possible that antitumor drugs affect calcium and bone metabolism associated with bone metastases. While these cases are rare, it is crucial for oncologists to be aware of hypocalcemia not only at the initiation of bone-modifying agents but also throughout the entire antitumor therapy, as hypocalcemia can lead to fatal outcomes.
- |||||||||| GSK690693 / GSK
Journal, IO biomarker: Resveratrol Delays Diabetic Cardiomyopathy Fibrosis by Regulating Mitochondrial Autophagy. (Pubmed Central) - Mar 29, 2024
GSK690693 (an AMPK inhibitor) suppressed the expression of p-AMPK, SIRT1, and SIRT3 and enhanced the protein expression of p22, XBP1s, and PINK. Resveratrol postpones dilated cardiomyopathy fibrosis by regulating the mitochondrial autophagy response through the AMP-activated protein kinase (AMPK)/silent mating type information regulation 2 homolog 1 (SIRT1)-mediated inositol-requiring enzyme 1 alpha (IRE1?)/PTEN-induced putative kinase 1 (PINK) signaling pathway.
- |||||||||| Rapivab (peramivir) / BioCryst, Relenza (zanamivir) / GSK, Vaxart, Xofluza (baloxavir marboxil) / Roche
Review, Journal: Retracted and republished from: "The current state of research on influenza antiviral drug development: drugs in clinical trial and licensed drugs". (Pubmed Central) - Mar 29, 2024
Currently, the influenza drugs recommended by the Food and Drug Administration are oseltamivir, zanamivir, peramivir, and baloxavir marboxil...Here, we summarized the cutting-edge research in mechanism of action, inhibitory activity, and clinical efficacy of drugs that have been approved and drugs that are still in clinical trials for influenza treatment. We hope this review will provide up-to-date and comprehensive information on influenza antivirals and generate hypotheses for screens and development of new broad-spectrum influenza drugs in the near future.
- |||||||||| Prolia (denosumab) / Amgen
Journal: Denosumab - protection for bone and beyond? (Pubmed Central) - Mar 29, 2024
We hope this review will provide up-to-date and comprehensive information on influenza antivirals and generate hypotheses for screens and development of new broad-spectrum influenza drugs in the near future. No abstract available
- |||||||||| Nucala (mepolizumab) / GSK
Review, Journal: Monitoring mepolizumab treatment in chronic rhinosinusitis with nasal polyps (CRSwNP): Discontinue, change, continue therapy? (Pubmed Central) - Mar 29, 2024
Understanding the immunological basis of CRSwNP opens up new non-surgical therapeutic approaches with biologics for patients with severe, uncontrolled courses. Here, we provide recommendations for follow-up, adherence to therapy intervals, possible therapy pauses, or discontinuation of therapy when mepolizumab is used as add-on therapy with intranasal glucocorticosteroids to treat adult patients with severe CRSwNP that cannot be adequately controlled with systemic glucocorticosteroids and/or surgical intervention.
- |||||||||| Cinqair (reslizumab) / Merck (MSD), UCB, Teva, Nucala (mepolizumab) / GSK, Fasenra (benralizumab) / AstraZeneca
Review, Journal: Eosinophil granulocytes in chronic inflammatory respiratory diseases and CRSwNP: Function, immunological basis, and clinical significance. (Pubmed Central) - Mar 29, 2024
Here, we provide recommendations for follow-up, adherence to therapy intervals, possible therapy pauses, or discontinuation of therapy when mepolizumab is used as add-on therapy with intranasal glucocorticosteroids to treat adult patients with severe CRSwNP that cannot be adequately controlled with systemic glucocorticosteroids and/or surgical intervention. The important role of eosinophils in immunological processes in the airway mucosa is comprehensively analyzed and can serve as a basis for current and future treatment approaches.
- |||||||||| Prolia (denosumab) / Amgen
Review, Journal: Evidence-Based Guideline for the management of osteoporosis in men. (Pubmed Central) - Mar 29, 2024
Taurine exerts lipid lowering effects through activating SIRT1/AMPK/FOXO1 signaling pathways and regulating their downstream targets. The recommendations are based on a comprehensive review of the latest research related to diagnostic and screening approaches for osteoporosis and its
- |||||||||| GSK 2336805 / J&J
TBD (Exhibit Hall F1; Poster Board Number: B226) - Mar 29, 2024 - Abstract #IMMUNOLOGY2024IMMUNOLOGY_2168;
As of week 3, mice were treated with two novel pharmacological inhibitors of IL17A or GSK805 as a positive control (10 mg/Kg/day)...Finally, the inhibitors reduced the expression of the profibrogenic genes (Col1a1, Acta, Loxl2 and Tgf?) (p<0.001) and reduced collagen deposition as measured by Picro sirius red area (p<0.05). In conclusion, our data suggest that inhibition of the IL17 pathway is a viable therapeutic strategy for liver fibrosis.
- |||||||||| Shingrix (zoster vaccine recombinant adjuvanted) / GSK, Japan Vaccine, Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant) / Merck (MSD)
Repurposing varicella zoster virus and human papillomavirus vaccines for local immunotherapy against solid tumors (Exhibit Hall F1; Poster Board Number: B215) - Mar 29, 2024 - Abstract #IMMUNOLOGY2024IMMUNOLOGY_2147;
Finally, IT injection of Shingrix and the E7 viral neoantigen peptide led to the eradication of all primary injected and abscopal tumors. Our results indicate that Shingrix is a versatile component for in-situ vaccination which can be combined with peptides derived from licensed vaccines or tumor antigens.
- |||||||||| Shingrix (zoster vaccine recombinant adjuvanted) / GSK, Japan Vaccine
Longitudinal analysis of immunological response to vaccination (Exhibit Hall F1; Poster Board Number: B941) - Mar 29, 2024 - Abstract #IMMUNOLOGY2024IMMUNOLOGY_1381;
This study explores the dynamic nature of the immune responses to vaccination with Td (Tetanus-diphtheria), PPSV23 (pneumococcal), and Shingrix (herpes zoster) vaccines...We characterized specific cell types responsible for adaptive immune responses through T/B cell sorting experiments and 10x analysis. This study highlights the importance of integrated transcriptome, immune repertoire, and single-cell profiling analysis to understand the complex interplay of innate and adaptive immune mechanisms.
- |||||||||| Mosquirix (RTS,S) / GSK
A potent pre-erthyrocytic malaria vaccine targeting a vulnerable epitope (Exhibit Hall F1; Poster Board Number: B935) - Mar 29, 2024 - Abstract #IMMUNOLOGY2024IMMUNOLOGY_1375;
Upon malaria challenge, 80% of mice immunized with Cquim-adjuvanted L9 VLPs were protected from blood parasitemia. In contrast, only 40% of mice vaccinated with RTS,S/AS01, the only commercially available malaria vaccine, exhibited protection against blood stage parasitemia, hilighting the importance of our vaccine.
- |||||||||| endurobol (GW501516) / Ligand, GSK
The role of PPAR? in murine T cell activation (Exhibit Hall F1; Poster Board Number: B768) - Mar 29, 2024 - Abstract #IMMUNOLOGY2024IMMUNOLOGY_766;
In contrast, only 40% of mice vaccinated with RTS,S/AS01, the only commercially available malaria vaccine, exhibited protection against blood stage parasitemia, hilighting the importance of our vaccine. To understand PPAR?'s impact on FAO in T cells, we stimulated na
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