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  • ||||||||||  vilanterol (GW642444H) / GSK, Incruse Ellipta (umeclidinium) / GSK, Veramyst (fluticasone furoate nasal spray) / GSK
    Journal:  Triple Therapy and Clinical Control in B+ COPD Patients: A Pragmatic, Prospective, Randomized Trial. (Pubmed Central) -  May 11, 2024   
    Four years of denosumab therapy were associated with increased BMD in KTRs, while untreated KTRs showed significant BMD losses at all sites. The ANTES B+ study is the first to: (1) explore the efficacy and safety of triple therapy in a population of B+ COPD patients and (2) use a composite index (CC) as the primary result of a COPD trial.
  • ||||||||||  Tecvayli (teclistamab-cqyv) / Genmab, J&J, Carvykti (ciltacabtagene autoleucel) / J&J, Blenrep (belantamab mafodotin-blmf) / GSK
    Journal, IO biomarker:  Antigen escape as a shared mechanism of resistance to BCMA-directed therapies in multiple myeloma. (Pubmed Central) -  May 10, 2024   
    Low-to-undetectable peripheral blood soluble BCMA levels correlated with the absence of BCMA expression by bone marrow plasma cells. Thus, although rare, loss of BCMA expression following TNFRSF17 gene deletions can occur following any BCMA-directed therapy and prevents response to subsequent anti-BCMA-directed treatments, underscoring the importance of verifying the presence of a target antigen.
  • ||||||||||  Xevudy (sotrovimab) / GSK, National Institutes of Health, Vir Biotech, National Institute of Allergy and Infectious Diseases
    Journal:  Use of Sotrovimab in Pregnancy: Experiences from the COVID-19 International Drug Pregnancy Registry. (Pubmed Central) -  May 10, 2024   
    A sizable proportion of sotrovimab-treated participants in the COVID-PR had underlying medical conditions associated with an increased risk of severe COVID-19. None of the assessable SAEs were considered to be related to sotrovimab treatment.
  • ||||||||||  Prolia (denosumab) / Amgen
    Review, Journal:  Modern treatment of unicameral and aneurysmatic bone cysts. (Pubmed Central) -  May 10, 2024   
    The historical treatment with intraosseous injection of methylprednisolone acetate into the bone cysts nowadays is reduced due to the morbidity of multiple injections and the risk of multiple pathologic fractures until the healing...Further studies are needed to confirm the effectiveness of denosumab and its side effects on skeletally immature patients...For simple bone cysts, the combination of curettage, bone graft, and ESIN showed the best results. Sclerotherapy for ABC also shows promising results.
  • ||||||||||  Botox (onabotulinumtoxin A) / GSK, AbbVie, Healis Therap
    Journal:  Does the setting for intradetrusor onabotulinumtoxinA injection for management of overactive bladder matter? (Pubmed Central) -  May 10, 2024   
    Patients in the OR group had a higher reported improvement as compared to the in-office group (81.4% vs. 73.3%, P = 0.03). In this cohort study of patients with OAB undergoing intradetrusor onabotulinumtoxinA injections, post procedural subjective improvement was high regardless of the setting in which the procedure was performed.
  • ||||||||||  Botox (onabotulinumtoxin A) / GSK, AbbVie, Healis Therap
    Trial completion date, Trial initiation date, Trial primary completion date:  Efficacy of Zinc Supplementation on Botox Treated Forehead Rhytids (clinicaltrials.gov) -  May 10, 2024   
    P=N/A,  N=40, Not yet recruiting, 
    In this cohort study of patients with OAB undergoing intradetrusor onabotulinumtoxinA injections, post procedural subjective improvement was high regardless of the setting in which the procedure was performed. Trial completion date: Jul 2024 --> Oct 2024 | Initiation date: Mar 2024 --> Aug 2024 | Trial primary completion date: Jul 2024 --> Oct 2024
  • ||||||||||  Botox (onabotulinumtoxin A) / GSK, AbbVie, Healis Therap
    Enrollment closed, Trial primary completion date:  A Study to Evaluate Safety and Efficacy of BOTOX in Adults With Moderate COPD (clinicaltrials.gov) -  May 10, 2024   
    P2,  N=40, Active, not recruiting, 
    Trial completion date: Dec 2025 --> Jun 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2025 --> Jun 2023; The study was terminated due to a change in GSK's R&D priorities. Recruiting --> Active, not recruiting | Trial primary completion date: Apr 2024 --> Jul 2024
  • ||||||||||  Botox (onabotulinumtoxin A) / GSK, AbbVie, Healis Therap
    Preclinical, Journal, Stroma:  Wnt16 Increases Bone-to-Implant Contact in an Osteopenic Rat Model by Increasing Proliferation and Regulating the Differentiation of Bone Marrow Stromal Cells. (Pubmed Central) -  May 9, 2024   
    We used an established rat model of cortical and trabecular femoral bone impairment following botox injections (2 injections of 8 units/leg each, starting and maintenance doses) to assess Wnt16 effects on whole bone morphology and implant osseointegration...They suggest a role for Wnt16 in modulating bone remodeling by reducing osteoclastic activity. Targeted strategies to temporally regulate Wnt16 after implant placement could be used to improve osseointegration by increasing the net pool of osteoprogenitor cells.
  • ||||||||||  Trelegy Ellipta (fluticasone furoate/umeclidinium bromide/vilanterol) / GSK, Innoviva, Theravance Biopharma, Anoro Ellipta (umeclidinium/vilanterol) / Innoviva, GSK, Veramyst (fluticasone furoate nasal spray) / GSK
    Journal:  Baseline characteristics and ICS/LAMA/LABA response in asthma: analyses from the CAPTAIN study. (Pubmed Central) -  May 9, 2024   
    P3
    Targeted strategies to temporally regulate Wnt16 after implant placement could be used to improve osseointegration by increasing the net pool of osteoprogenitor cells. Unlike previous findings with type 2 biomarkers, lung function, bronchodilator reversibility, age and age at asthma onset do not appear to predict response to inhaled therapy.
  • ||||||||||  Prolia (denosumab) / Amgen
    Observational data, Retrospective data, Journal:  Secondary fracture prevention in Spanish primary care: results of the PREFRAOS Study. (Pubmed Central) -  May 9, 2024   
    Across Spanish PC, we observed a large gap in the treatment and follow-up of elderly subjects experiencing a fragility fracture. Our data highlights the urgent need to improve secondary fracture prevention in PC.
  • ||||||||||  GSK1521498 / GSK
    Journal:  Total-body imaging of mu-opioid receptors with [11C]carfentanil in non-human primates. (Pubmed Central) -  May 9, 2024   
    [11C]CFN total-body PET scans could be a useful approach for studying mechanism of action of MOR drugs used in the treatment of acute and chronic opioid use disorder and their effect on the biodistribution of synthetic opioids such as CFN. GSK1521498 could be a potential naloxone alternative to reverse opioid overdose.
  • ||||||||||  Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap, Brexafemme (ibrexafungerp) / SCYNEXIS, GSK, fosmanogepix (APX001) / Basilea
    Review, Journal:  Management of invasive candidiasis: A focus on rezafungin, ibrexafungerp, and fosmanogepix. (Pubmed Central) -  May 9, 2024   
    Lastly, fosmanogepix, a mechanistically novel, investigational antifungal agent, may be a potential future option in the management of IC and candidemia. Future research is needed to evaluate the potential use of these agents among diverse patient populations.
  • ||||||||||  Shingrix (zoster vaccine recombinant adjuvanted) / GSK, Japan Vaccine
    Journal:  Unveiling the Uncertainties: Exploring the Utility of Herpes Zoster Vaccines. (Pubmed Central) -  May 9, 2024   
    In this editorial, we will delve into the global and Indian burden of herpes zoster, explore its complications, highlight the importance of prevention, shed light on the Shingrix vaccine, discuss its composition, and present the research on safety and efficacy, including the ZOE-50 and ZOE-70 studies...How to cite this article: Vora A, Tiwaskar M. Unveiling the Uncertainties: Exploring the Utility of Herpes Zoster Vaccines. J Assoc Physicians India 2023;71(11):11-12.
  • ||||||||||  VH4524184 / ViiV Healthcare, GSK
    Enrollment open:  VH4524184 Proof-of-Concept in Treatment-Na (clinicaltrials.gov) -  May 9, 2024   
    P2,  N=28, Recruiting, 
    J Assoc Physicians India 2023;71(11):11-12. Not yet recruiting --> Recruiting
  • ||||||||||  Jemperli (dostarlimab-gxly) / GSK, Zejula (niraparib) / GSK, J&J
    Trial completion date, Trial primary completion date, Combination therapy:  Niraparib in Combination With Dostarlimab in Patients With Recurrent or Progressive Cervix Cancer (clinicaltrials.gov) -  May 8, 2024   
    P2,  N=66, Recruiting, 
    Considering their dismal prognosis, further investigation is warranted to test the use of PARPi in uLMS, and particularly in the setting of BRCA1/2 alterations. Trial completion date: Jul 2026 --> Jul 2027 | Trial primary completion date: Jul 2024 --> Jul 2025
  • ||||||||||  Kesimpta (ofatumumab subcutaneous) / Novartis, Genmab
    Journal:  The patient-reported wearing-off phenomenon with monoclonal antibody treatments for multiple sclerosis. (Pubmed Central) -  May 8, 2024   
    Patients receiving natalizumab, ocrelizumab, ofatumumab, or rituximab at a tertiary multiple sclerosis center were invited to take an online survey interrogating their monoclonal antibody experience...The wearing-off phenomenon is common, associated with depression, and reduces treatment satisfaction. Research addressing mitigation strategies is needed.
  • ||||||||||  GW-2580 / GSK, TL-1-85 / Massachusetts General Hospital, Wellcome Sanger Institute
    Journal:  Prognostic value and immunological role of MMRN1: a rising star in cancer. (Pubmed Central) -  May 8, 2024   
    Our analysis demonstrated a significant relationship between MMRN1 and prognosis, tumor immunity, and drug sensitivity of several tumors. As a rising star in cancer, it needs further research.
  • ||||||||||  Benlysta (belimumab) / GSK, Lupkynis (voclosporin) / Aurinia Pharma, Saphnelo (anifrolumab) / AstraZeneca
    Review, Journal:  Systemic Lupus Erythematosus: A Review. (Pubmed Central) -  May 7, 2024   
    Hydroxychloroquine is first-line therapy and reduces disease activity, morbidity, and mortality. When needed, additional immunosuppressive and biologic therapies include azathioprine, mycophenolate mofetil, cyclophosphamide, belimumab, voclosporin, and anifrolumab.
  • ||||||||||  Nucala (mepolizumab) / GSK
    Journal:  A tailored approach to refractory severe Mepolizumab-associated headache: a case study. (Pubmed Central) -  May 7, 2024   
    Our experience indicates that a tailored strategy for managing severe asthmatic patients, who have experienced side effects from biologic drugs, can be effective in maintaining drug efficacy while minimizing side effects. Further studies on a larger number of patients are required to demonstrate whether the positive outcomes here described are replicable on a larger scale.
  • ||||||||||  Nucala (mepolizumab) / GSK
    Journal:  The Role of ACT Score in Mepolizumab Discontinuation. (Pubmed Central) -  May 7, 2024   
    In this real-world study, we find that high eosinophil count may not be adequate in screening which individuals will benefit from mepolizumab. Up to 17% of patients fail therapy within 6 months, with male sex and low ACT score increasing risk of mepolizumab discontinuation at Cleveland Clinic.
  • ||||||||||  EZM2302 / GSK, Ipsen
    Preclinical, Journal:  A CARM1 Inhibitor Potently Suppresses Breast Cancer Both In Vitro and In Vivo. (Pubmed Central) -  May 7, 2024   
    The combination of iCARM1 with either endocrine therapy drugs or etoposide demonstrated synergistic effects in inhibiting the growth of breast tumors. In summary, targeting CARM1 by iCARM1 effectively suppresses breast tumor growth, offering a promising therapeutic approach for managing breast cancers in clinical settings.
  • ||||||||||  Arexvy (respiratory syncytial virus vaccine, adjuvanted) / GSK, Abrysvo (PF-06928316) / Pfizer
    Review, Journal:  Respiratory Syncytial Virus Infection in Older Adults: An Update. (Pubmed Central) -  May 7, 2024   
    There is an urgent need for antivirals and preventive strategies in this population, particularly in individuals at higher risk of severe outcomes following RSV infection. In this review, we describe prevention and treatment strategies for RSV illnesses, with a deep focus on the novel data on vaccination that has become available (Arexvy, GSK, and Abrysvo, Pfizer) for older adults.