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  • ||||||||||  Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin
    Trial completion, Phase classification:  Pharmacokinetics Comparison Study of JT1801 and NESP (clinicaltrials.gov) -  Nov 21, 2023   
    P4,  N=74, Completed, 
    DEXA screening, and treatment with oral bisphosphonates is cost-effective if they reduce the PPF rate by just 0.6%. Recruiting --> Completed | Phase classification: P1 --> P4
  • ||||||||||  Prolia (denosumab) / Amgen, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
    Trial completion, Trial completion date:  Romosozumab Versus Denosumab for Osteoporosis in Long-term Glucocorticoid Users (clinicaltrials.gov) -  Nov 21, 2023   
    P4,  N=70, Completed, 
    Recruiting --> Completed | Phase classification: P1 --> P4 Active, not recruiting --> Completed | Trial completion date: Apr 2024 --> Nov 2023
  • ||||||||||  Remicade (infliximab) / Merck (MSD), Mitsubishi Tanabe, J&J, Enbrel (etanercept) / Pfizer, Amgen, Humira (adalimumab) / AbbVie
    Journal:  Use of Immunosuppression and the Risk of Subsequent Overall or Cancer Mortality. (Pubmed Central) -  Nov 21, 2023   
    Our results, in a cohort where the indication for treatment was proven unassociated with mortality risk, found that commonly used immunosuppressants-especially the antimetabolites methotrexate, mycophenolate mofetil, and azathioprine; the TNF inhibitors adalimumab and infliximab, and cyclosporine-were not associated with increased overall and CM over a median cohort follow-up of 10.0 years. These results suggest the safety of these agents with respect to overall and CM for patients treated with immunosuppression for a wide range of inflammatory diseases.
  • ||||||||||  Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
    Enrollment open:  A Study of Romosozumab (EVENITY (clinicaltrials.gov) -  Nov 21, 2023   
    P4,  N=100, Recruiting, 
    These results suggest the safety of these agents with respect to overall and CM for patients treated with immunosuppression for a wide range of inflammatory diseases. Not yet recruiting --> Recruiting
  • ||||||||||  brazikumab (AMG 139) / AstraZeneca
    Phase classification, Trial termination:  INTREPID: An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) -  Nov 21, 2023   
    P2/3,  N=89, Terminated, 
    Romosozumab treatment did not impact knee pain or function in postmenopausal women with osteoporosis and knee osteoarthritis and resulted in significant BMD gains in these women. Phase classification: P2b --> P2/3 | Active, not recruiting --> Terminated; Strategic decision to discontinue the development of brazikumab in inflammatory bowel disease.
  • ||||||||||  ordesekimab (AMG 714) / Amgen, Sanofi
    Phase classification, Trial completion date, Trial primary completion date:  PRV-015 in Gluten-free Diet Non-responsive Celiac Disease (clinicaltrials.gov) -  Nov 20, 2023   
    P2,  N=220, Recruiting, 
    Phase classification: P1b/2 --> P1/2 Phase classification: P2b --> P2 | Trial completion date: Dec 2023 --> Aug 2024 | Trial primary completion date: Dec 2023 --> Aug 2024
  • ||||||||||  Visken (pindolol) / Novartis, Henletor (torsemide) / Orchid
    Review, Journal:  How do we define high and low dose intensity of heart failure medications: a scoping review. (Pubmed Central) -  Nov 20, 2023   
    Our comprehensive scoping review studies identified the most frequently used definition of dose intensity for 40 medications but could not identify the definitions for 4 medications. The results of the current scoping review will be helpful for clinicians to have awareness whether the currently prescribed dose is considered high - requiring close monitoring of side effects, or low - requiring more aggressive up-titration.
  • ||||||||||  cabiralizumab (BMS-986227) / Ono Pharma, BMS, sotigalimab (APX005M) / Pyxis Oncology, Opdivo (nivolumab) / Ono Pharma, BMS
    Journal, PD(L)-1 Biomarker, IO biomarker:  A bedside to bench study of anti-PD-1, anti-CD40, and anti-CSF1R indicates that more is not necessarily better. (Pubmed Central) -  Nov 19, 2023   
    P1
    While it is impossible to directly infer human doses from murine studies, careful intra-species evaluation can provide important insight. Cabiralizumab dose optimization is necessary for this patient population with limited treatment options.
  • ||||||||||  ATI-2231 / Aclaris
    Trial suspension, Metastases:  ATI-2231 in Advanced Solid Tumor Malignancies (clinicaltrials.gov) -  Nov 19, 2023   
    P1,  N=36, Suspended, 
    Phase classification: P3 --> P2/3 Not yet recruiting --> Suspended
  • ||||||||||  NB004 / Ningbo Tai Kang
    Enrollment change, Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, Metastases:  A Study of NB004 as Monotherapy or Combination Therapy in Patients With Advanced Solid Tumors (clinicaltrials.gov) -  Nov 18, 2023   
    P1,  N=120, Recruiting, 
    Notably, all four cases responded positively to romiplostim treatment, and no significant adverse events were observed. N=36 --> 120 | Trial completion date: Sep 2023 --> Jun 2025 | Trial primary completion date: May 2023 --> Feb 2025
  • ||||||||||  Lumakras (sotorasib) / Amgen
    Journal:  KRAS-Degrading Compounds: A Novel Approach to Treat Cancer by Targeting Both Wild-Type and Mutated KRAS Forms. (Pubmed Central) -  Nov 17, 2023   
    Notably, covalent inhibitors such as sotorasib show success in binding to specific KRAS mutations...This Patent Highlight reveals exemplary KRAS-degrading compounds with anti-tumor activity, effective against both wild-type and mutated KRAS. They present desirable pharmacological properties, promising a revolution in cancer treatment upon further clinical investigation.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Review, Journal:  Management of Giant Cell Tumor of the Hyoid bone- A rare Clinical Entity with Review of Literature. (Pubmed Central) -  Nov 17, 2023   
    They present desirable pharmacological properties, promising a revolution in cancer treatment upon further clinical investigation. GCTs of the larynx have a good prognosis and can be treated successfully through complete resection of the tumor, negating the need for adjunctive therapy such as radiation, chemotherapy or denosumab therapy.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Review, Journal:  Glucocorticoid-induced osteoporosis: an overview with focus on its prevention and management. (Pubmed Central) -  Nov 17, 2023   
    Since impaired bone formation represents the main mechanism by which GCs negatively affect skeletal health, osteoanabolic therapies appear to be pathophysiologically the more appropriate and appealing option, although cost considerations currently limit their use to selected severe cases. Regardless of the agent selected to mitigate the impact of GCs on the skeleton, what is most crucial is that the treating physician correctly stratifies the risk and intervenes at the right time.