- |||||||||| morphine-6-glucuronide (M6G) / PAION
Review, Journal, Adverse events: Incidence of drug-related adverse events related to the use of high-alert drugs: A systematic review of randomized controlled trials. (Pubmed Central) - Apr 22, 2024 The most reported drug classes in the articles included that were related to incidence of drug-related adverse events in use of high-alert medications: morphine, M6G-glucuronide, haloperidol, promethazine, ivabradine, digoxin, warfarin, ximelagatran, cyclophosphamide, cyclosporine, and ATG. The formulate protocols for the use of these medications, with importance placed on evaluating, among the classes, the medication that causes the least harm.
- |||||||||| Enbrel (etanercept) / Pfizer, Amgen
Journal: Osteoporosis presenting during pregnancy and lactation: wait and reassess. (Pubmed Central) - Apr 22, 2024 Genomic screen was negative but she had mild ankylosing spondylitis previously well controlled on etanercept...The marked increase in bone density resulted from the combined effects of spontaneous recovery and pharmacotherapy. Spontaneous recovery of bone mass and strength should occur during 12
- |||||||||| Actemra IV (tocilizumab) / Roche, JW Pharma, Enbrel (etanercept) / Pfizer, Amgen, Humira (adalimumab) / AbbVie
Retrospective data, Journal: Risk factor of non-tuberculous Mycobacterium infection in patients with rheumatoid arthritis and other autoimmune diseases receiving biologic agents: A multicenter retrospective study. (Pubmed Central) - Apr 22, 2024 In the patients undergoing therapy with biologic agents, although NTM complication was rare, it could be fatal. In particular, for patients on a relatively high dose corticosteroids, careful observation is essential for identifying NTM complication, even if the MAC antibody test is negative.
- |||||||||| STAR-0310 / Astria Therap
Development and characterization of STAR-0310: a novel OX40 antagonistic monoclonal antibody (Poster Zone) - Apr 21, 2024 - Abstract #EAACI2024EAACI_2143; Conclusion STAR-0310, an anti-OX40 antibody, demonstrates the potential for increased half-life, high-potency T cell inhibition, and reduced toxicities with minimized effector (ADCC) functions. These promising preclinical findings support the potential use of STAR-0310 in moderate-to-severe AD and other immunologic diseases.
- |||||||||| briquilimab (JSP191) / Jasper Therap
SPOTLIGHT: A Phase 1b/2a, Dose Escalation Trial of Safety, Pharmacokinetic/Pharmacodynamic and Preliminary Clinical Activity of Briquilimab in Adult Patients with Chronic Inducible Urticaria (CIndU) Who Remain Symptomatic Despite Treatment with H1-Antihis (Poster Zone) - Apr 21, 2024 - Abstract #EAACI2024EAACI_1209; These promising preclinical findings support the potential use of STAR-0310 in moderate-to-severe AD and other immunologic diseases. Results Safety and tolerability: Review of laboratory data (hematology, clinical chemistry, urinalysis), physical examinations, vital signs, ECG, reports of treatment emergent adverse events (TEAEs) Pharmacokinetics: Cmax, tmax and AUClast Preliminary Efficacy: Change from baseline to Week 12 in provocation testing scores (TempTest
- |||||||||| Prolia (denosumab) / Amgen
Journal: Bone loss after discontinuation of denosumab: the devil is in the details. (Pubmed Central) - Apr 21, 2024 Bone turnover markers were appropriately suppressed and bone mineral density increased in the spine and hip. This case illustrates how the overshooting phenomenon following denosumab discontinuation may be compounded by the development of secondary conditions, which can result in suboptimal response to antiresorptive osteoporosis medications.
- |||||||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Journal: Reconstruction of Remodeling units reveals positive effects after 2 and 12 (Pubmed Central) - Apr 19, 2024 These evolving bone packets may reflect early stimulation of bone formation that contributes to the increase in completed wall thickness at M12. These data suggest that romosozumab induces a positive bone balance due to its effects on bone resorption and formation at the level of the remodeling unit, contributing to the positive effects on bone mass, structure, and fracture risk.
- |||||||||| Tepezza (teprotumumab-trbw) / Roche, Amgen
Journal: Teprotumumab improves light sensitivity in patients with thyroid eye disease. (Pubmed Central) - Apr 19, 2024 Teprotumumab improves light sensitivity in patients with acute and chronic TED. The results of this study highlight that the improvements in light sensitivity following treatment are not directly related to the mechanical changes in TED, suggesting another underlying mechanism is
- |||||||||| Journal: Drug therapy in juvenile spondyloarthritis. (Pubmed Central) - Apr 19, 2024
Long-term follow-up studies continue to demonstrate acceptable safety profiles. There is need for more real-world data on drug efficacy from Registry studies and research on effective de-escalation strategies.
- |||||||||| Praluent (alirocumab) / Sanofi, Regeneron, Repatha (evolocumab) / Amgen, Astellas
Journal: Safety of Monoclonal Antibodies Inhibiting PCSK9 in Pregnancy: Disproportionality Analysis in VigiBase (Pubmed Central) - Apr 19, 2024 There is need for more real-world data on drug efficacy from Registry studies and research on effective de-escalation strategies. In conclusion, this study showed that, currently, there are no signals of increased reporting of spontaneous abortion with alirocumab and evolocumab compared with the full database and statins in VigiBase
- |||||||||| Ibrance (palbociclib) / Pfizer
Trial completion, Trial completion date, Trial primary completion date, Surgery: NCI-2018-01050: Hydroxychloroquine, Palbociclib, and Letrozole Before Surgery in Treating Patients With Estrogen Receptor Positive, HER2 Negative Breast Cancer (clinicaltrials.gov) - Apr 18, 2024 P1/2, N=15, Completed, Trial primary completion date: Nov 2026 --> Mar 2026 Active, not recruiting --> Completed | Trial completion date: Dec 2025 --> Apr 2024 | Trial primary completion date: Dec 2025 --> Apr 2024
- |||||||||| ECT204 / Eureka Therap
Trial completion date, Metastases: ARYA3: T-Cell Therapy (ECT204) in Adults With Advanced HCC (clinicaltrials.gov) - Apr 18, 2024 P2, N=30, Recruiting, In conclusion, a fixed-dose regimen of tezepelumab 210 mg subcutaneously Q4W is appropriate for eligible adults and adolescents with severe, uncontrolled asthma. Trial completion date: Dec 2027 --> Dec 2026
- |||||||||| Imlygic (talimogene laherparepvec) / Amgen, Yondelis (trabectedin) / PharmaMar, J&J, Opdivo (nivolumab) / BMS
Trial completion date, Trial primary completion date: SOC-1882: Talimogene Laherparepvec, Nivolumab and Trabectedin for Sarcoma (clinicaltrials.gov) - Apr 18, 2024 P2, N=40, Recruiting, Trial completion date: Dec 2027 --> Dec 2026 Trial completion date: Mar 2024 --> Mar 2025 | Trial primary completion date: Dec 2023 --> Dec 2024
- |||||||||| sovilnesib (AMG 650) / Volastra Therap
Enrollment open, Phase classification, Metastases: A Study of Sovilnesib in Subjects with Ovarian Cancer (clinicaltrials.gov) - Apr 18, 2024 P1, N=120, Recruiting, Trial completion date: Dec 2032 --> Apr 2025 | Trial primary completion date: Jun 2023 --> Mar 2024 Not yet recruiting --> Recruiting | Phase classification: P1b --> P1
- |||||||||| Tepezza (teprotumumab-trbw) / Roche, Amgen
Journal: Teprotumumab in thyroid eye disease. (Pubmed Central) - Apr 17, 2024 In this review, we summarize the clinical features and pathophysiology of TED, disease course, and traditional management methods. We further detail the development of teprotumumab, the founding studies that brought it to its FDA approval, adverse events profile, and ongoing as well as future investigations.
- |||||||||| efruxifermin (AKR-001) / Akero Therap
Biomarker, Retrospective data, Review, Journal, MRI: Efficacy of pharmacologic interventions on magnetic resonance imaging biomarkers in patients with nonalcoholic fatty liver disease: systematic review and network meta-analysis. (Pubmed Central) - Apr 17, 2024 We further detail the development of teprotumumab, the founding studies that brought it to its FDA approval, adverse events profile, and ongoing as well as future investigations. Several drug classes may reduce LFC in patients with NAFLD without a significant effect on fibrosis; nevertheless, trial duration was small, and confidence in the effect estimates was low.
- |||||||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Preclinical, Journal: Influence of anti-sclerostin monoclonal antibody in the repair of post-extraction sockets of ovariectomized rats. (Pubmed Central) - Apr 17, 2024 Several drug classes may reduce LFC in patients with NAFLD without a significant effect on fibrosis; nevertheless, trial duration was small, and confidence in the effect estimates was low. Scl-Ab-based medication did not accelerate alveolar bone formation but exhibited better post-extraction repair characteristics, and collagen content compared to ovariectomized animals only.
- |||||||||| Bmab 1000 (denosumab biosimilar) / Biocon, Yoshindo
Trial completion, Trial completion date, Trial primary completion date: Comparison of Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Bmab 1000 and Prolia (clinicaltrials.gov) - Apr 17, 2024 P1, N=190, Completed, Trial completion date: Dec 2023 --> Dec 2024 Active, not recruiting --> Completed | Trial completion date: Feb 2024 --> Oct 2023 | Trial primary completion date: Feb 2024 --> Oct 2023
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