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  • ||||||||||  Observational data, Journal, Real-world evidence:  Real-World Insights From T (Pubmed Central) -  May 13, 2025   
    This NMA further reaffirmed that inclisiran provided comparable LDL-C reduction vs. alirocumab (MD: -1.93% [95% CrI: -8.56, 4.20]) and evolocumab (MD: 2.00% [95% CrI: -4.58, 8.60]) among patients with ASCVD and/or high CV risk on MTD statins. This study offers preliminary evidence supporting the effective and safe use of bDMARDs in patients with SpA and CKD.
  • ||||||||||  Prolia (denosumab) / Amgen
    Review, Journal:  Phytoestrogens as Potential Anti-Osteoporosis Nutraceuticals: Major Sources and Mechanism(s) of Action. (Pubmed Central) -  May 13, 2025   
    Denosumab, an FDA-approved antiresorptive monoclonal antibody, also has drawbacks including high costs, biannual subcutaneous injections, slow healing, impaired bone growth and side effects like eczema, flatulence, cellulitis, osteonecrosis of the jaw (ONJ) and an increased risk of spinal fractures after discontinuation of treatment...Their tissue-selective activities are particularly significant: anti-estrogenic effects in reproductive tissues may lower the risk of hormone-related cancers (such as ovarian, uterine, breast, and prostate cancers), while estrogenic effects on bone could contribute to the preservation of bone mineral density.Phytoestrogens are, thus, used in managing breast and prostate cancers, cardiovascular diseases, menopause, and osteoporosis. The presentreview focuses on the botanical origin,classification, sources and mechanism(s) of action of major phytoestrogens, their potential in prevention and management of osteoporosis and the requirement for additional clinical trials to achieve more definitive outcomes in order to confirm their efficacy and dosage safety.
  • ||||||||||  Revuforj (revumenib) / Syndax Pharma
    Trial primary completion date:  Evaluation of Revumenib in Participants With Colorectal Cancer and Other Solid Tumors (clinicaltrials.gov) -  May 13, 2025   
    P1/2,  N=42, Active, not recruiting, 
    The presentreview focuses on the botanical origin,classification, sources and mechanism(s) of action of major phytoestrogens, their potential in prevention and management of osteoporosis and the requirement for additional clinical trials to achieve more definitive outcomes in order to confirm their efficacy and dosage safety. Trial primary completion date: Mar 2025 --> Dec 2025
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD), Stivarga (regorafenib) / Bayer
    Trial completion date, Trial primary completion date:  RENOTACE: Regorafenib-pembrolizumab vs. TACE/TARE in Intermediate Stage HCC Beyond Up-to-7 (clinicaltrials.gov) -  May 13, 2025   
    P3,  N=496, Active, not recruiting, 
    Not yet recruiting --> Recruiting Trial completion date: Apr 2027 --> Feb 2026 | Trial primary completion date: Oct 2025 --> Feb 2026
  • ||||||||||  Ibrance (palbociclib) / Pfizer, Kisqali (ribociclib) / Novartis
    Journal:  Rechallenge of an alternative CDK 4/6 inhibitor after hepatotoxicity in the treatment of hormone-positive metastatic breast cancer. (Pubmed Central) -  May 13, 2025   
    Once her liver enzymes resolved to grade 1 toxicity, she was transitioned to another CDK 4/6 inhibitor, palbociclib. The patient has remained on palbociclib for 1 year of treatment with normalization of her liver function enzymes and stable disease.DiscussionThis case presents a successful rechallenge of an alternative CDK 4/6 inhibitor after grade 4 ribociclib-induced hepatotoxicity and reviews similar cases of ribociclib-induced hepatoxicity and management strategies.
  • ||||||||||  Ibrance (palbociclib) / Pfizer
    Trial completion date:  Palbociclib in Patients With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) -  May 13, 2025   
    P2,  N=19, Active, not recruiting, 
    The patient has remained on palbociclib for 1 year of treatment with normalization of her liver function enzymes and stable disease.DiscussionThis case presents a successful rechallenge of an alternative CDK 4/6 inhibitor after grade 4 ribociclib-induced hepatotoxicity and reviews similar cases of ribociclib-induced hepatoxicity and management strategies. Trial completion date: Dec 2024 --> Dec 2025
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    Enrollment change, Trial termination:  Blinatumomab Bridging Therapy for BALL (clinicaltrials.gov) -  May 13, 2025   
    P2,  N=2, Terminated, 
    Trial completion date: Dec 2024 --> Dec 2025 N=35 --> 2 | Recruiting --> Terminated; poor accrual
  • ||||||||||  Journal:  Treatment of Older Patients With ALL. (Pubmed Central) -  May 12, 2025   
    In early T-cell precursor ALL, HSCT is still needed. To further improve outcomes in older patients, novel agents such as subcutaneous blinatumomab, CAR T cells, newer-generation TKIs, and menin inhibitors should be investigated in the frontline setting.
  • ||||||||||  Opdivo (nivolumab) / Ono Pharma, BMS
    Trial completion:  DEPEND: De-Escalation Therapy for Human Papillomavirus Negative Disease (clinicaltrials.gov) -  May 12, 2025   
    P2,  N=35, Completed, 
    To further improve outcomes in older patients, novel agents such as subcutaneous blinatumomab, CAR T cells, newer-generation TKIs, and menin inhibitors should be investigated in the frontline setting. Recruiting --> Completed
  • ||||||||||  Lumakras (sotorasib) / Amgen, docetaxel / Generic mfg.
    Journal:  Combination therapy of sotorasib and docetaxel overcomes resistance to (Pubmed Central) -  May 12, 2025   
    The patient received combination therapy with sotorasib and docetaxel, which resulted in remarkable efficacy. This case supports further investigation of sotorasib in combination with chemotherapy for treating KRAS G12C-mutated NSCLC with co-mutations.
  • ||||||||||  methotrexate / Generic mfg., Enbrel (etanercept) / Pfizer, Amgen
    Journal:  Subclinical Enthesitis in Children with Chronic Nonbacterial Osteomyelitis. (Pubmed Central) -  May 12, 2025   
    Subclinical enthesitis can be observed especially in CNO patients with overlappin- genthesitis-related arthritis features. The use of US may prove beneficial in detecting subclini- cal enthesitis and predicting disease flare.
  • ||||||||||  lometrexol (T-64) / Amgen
    Journal:  Inhibition of Purine Metabolism Promotes the Differentiation of Neuroblastoma Driven by MYCN. (Pubmed Central) -  May 12, 2025   
    The use of US may prove beneficial in detecting subclini- cal enthesitis and predicting disease flare. These findings establish purine metabolic enzyme inhibition as a viable therapeutic strategy to induce differentiation and attenuate tumor progression in high-risk MYCN-amplified NBs.
  • ||||||||||  Repatha (evolocumab) / Amgen, Astellas
    Preclinical, Journal:  Huotan Jiedu Tongluo Decoction inhibits ferroptosis by regulating Nrf2/GPX4 pathway to ameliorate atherosclerotic lesions in ApoE~(-/-) mice (Pubmed Central) -  May 12, 2025   
    Seventy-five ApoE~(-/-) mice were randomly divided into model group, low-, medium-, and high-dose of Huotan Jiedu Tongluo Decoction groups, and evolocumab group(n=15), and 15 C57BL/6J mice were selected as the blank group...In addition, Huotan Jiedu Tongluo Decoction up-regulated the protein and mRNA levels of Nrf2, GPX4, and SLC7A11, while down-regulating the protein and mRNA levels of ACSL4. In summary, Huotan Jiedu Tongluo Decoction can effectively alleviate AS lesions in ApoE~(-/-) mice by activating the Nrf2/GPX4 pathway, reducing lipid peroxidation, and inhibiting ferroptosis.
  • ||||||||||  Dupixent (dupilumab) / Sanofi, Regeneron, Tezspire (tezepelumab-ekko) / AstraZeneca, Amgen, Xolair (omalizumab) / Roche, Novartis
    Review, Journal:  Combination of allergen-specific immunotherapy with biologics in severe asthma: contra-intuitive or rational? (Pubmed Central) -  May 12, 2025   
    In a few landmark trials of AIT added to biologics (omalizumab, dupilumab or tezepelumab) mechanisms were also studied, unveiling additional benefit of these combinations not only enhancing safety and tolerability, but possibly also efficacy. We here present a summary of the clinical trials combining immunotherapy with aeroallergens with biologic therapy in patients with respiratory allergy and discuss the cons and pros of AIT in patients with severe allergic asthma on biological therapy, concluding this combination could benefit many of these patients.
  • ||||||||||  Imlygic (talimogene laherparepvec) / Amgen
    Biomarker, Review, Journal:  In Situ Cancer Vaccines: Redefining Immune Activation in the Tumor Microenvironment. (Pubmed Central) -  May 12, 2025   
    Currently approved in situ vaccines, such as T-VEC, have demonstrated clinical promise, while ongoing clinical trials continue to explore novel strategies for broader efficacy...However, significant barriers such as tumor heterogeneity, immune evasion, and logistical challenges remain. This review explores strategies for developing potent cancer vaccines, examines ongoing clinical trials, evaluates immune stimulation methods, and discusses prospects for advancing in situ cancer vaccination.
  • ||||||||||  Prolia (denosumab) / Amgen, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
    Review, Journal:  An update on the pharmacotherapy of osteoporosis. (Pubmed Central) -  May 12, 2025   
    Future directions in osteoporosis management emphasize advancing treatment strategies through novel drug targets and innovative delivery systems, alongside personalized medicine approaches considering individual genetic and comorbidity profiles. Enhanced adherence strategies and further research into combination therapies and monitoring tools are crucial for improving prevention and treatment outcomes, ultimately reducing the fragility fracture burden worldwide.
  • ||||||||||  Praluent (alirocumab) / Sanofi, Regeneron, Leqvio (inclisiran) / Novartis, Repatha (evolocumab) / Amgen, Astellas
    Journal:  RNA interference versus antibody-based PCSK9 inhibition for the prevention of cardiovascular disease: A drug-target Mendelian randomization study. (Pubmed Central) -  May 11, 2025   
    For a given reduction in apoB levels, genetically predicted reductions in PCSK9 function (mimicking PCSK9 neutralizing antibodies) and liver PCSK9 gene expression levels (mimicking PCSK9 RNA interference) were comparably associated with a lower risk of coronary artery disease. These genetic data suggest that LDL-C/apoB reductions may provide cardiovascular benefits, regardless of how PCSK9 function is inhibited.
  • ||||||||||  Ibrance (palbociclib) / Pfizer
    P1/2 data, Journal:  Targeting autophagy plus high-dose CDK4/6 inhibitors in advanced HR+HER2- breast cancer: A phase 1b/2 trial. (Pubmed Central) -  May 11, 2025   
    P1/2
    These genetic data suggest that LDL-C/apoB reductions may provide cardiovascular benefits, regardless of how PCSK9 function is inhibited. Combined HCQ with high-dose CDK4/6i palbociclib (200 mg, qd) showed tolerable toxicity and promising efficacy for patients with advanced HR+/HER2- breast cancer after CDK4/6i failure.
  • ||||||||||  Enbrel (etanercept) / Pfizer, Amgen
    Utility of F18- FDG PET/CT in plasmablastic lymphoma (PBL) (Science Pavilion) -  May 10, 2025 - Abstract #SNMMI2025SNMMI_1246;    
    This study offers real-world evidence for clinical decision-making and treatment optimization. 3 patients were HIV positive one HIV negative patient had
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    Review, Journal:  The Role of Transplant for Philadelphia-positive B-cell Acute Lymphoblastic Leukemia in 2025. (Pubmed Central) -  May 9, 2025   
    Simultaneously, our ability to stratify disease risk has greatly enhanced with the advent of ultrasensitive measurable residual disease (MRD) assessment tools and the utilization of comprehensive disease molecular profiling, and thus, identifying lower risk patients who can be cured with non-transplant approaches. With evolving treatment options for Ph?+?ALL, the historical notion that allo-HSCT in first complete remission is essential to cure all adult patients with Ph?+?ALL is being challenged and the benefit of consolidation with transplant may extend to certain patient populations.
  • ||||||||||  Praluent (alirocumab) / Sanofi, Regeneron, Repatha (evolocumab) / Amgen, Astellas
    Trial completion:  PERI-DYS: Prospective German Very High Cardiovascular Risk Patients Dyslipidemia Treatment Indication Registry (clinicaltrials.gov) -  May 9, 2025   
    P=N/A,  N=1695, Completed, 
    With evolving treatment options for Ph?+?ALL, the historical notion that allo-HSCT in first complete remission is essential to cure all adult patients with Ph?+?ALL is being challenged and the benefit of consolidation with transplant may extend to certain patient populations. Active, not recruiting --> Completed
  • ||||||||||  efruxifermin (AKR-001) / Akero Therap
    Journal:  Efruxifermin in Compensated Liver Cirrhosis Caused by MASH. (Pubmed Central) -  May 9, 2025   
    P2
    In patients with compensated cirrhosis caused by MASH, efruxifermin did not significantly reduce fibrosis at 36 weeks. (Funded by Akero Therapeutics; SYMMETRY ClinicalTrials.gov number, NCT05039450.).