- |||||||||| Ibrance (palbociclib) / Pfizer, Erbitux (cetuximab) / Eli Lilly
Trial completion, Trial completion date: PD 0332991 and Cetuximab in Patients With Incurable SCCHN (clinicaltrials.gov) - Dec 21, 2023 P1/2, N=96, Completed, Active, not recruiting --> Completed | Trial completion date: Oct 2024 --> Nov 2023
- |||||||||| Ibrance (palbociclib) / Pfizer, Bosulif (bosutinib) / Pfizer
Trial completion date, Trial primary completion date, Metastases: WI231696: Bosutinib, Palbocicilib and Fulvestrant for HR+HER2- Advanced Breast Cancer Refractory to a CDK4/6 Inhibitor (clinicaltrials.gov) - Dec 20, 2023 P1, N=19, Active, not recruiting, Trial completion date: Jul 2024 --> Oct 2023 | Active, not recruiting --> Terminated | Trial primary completion date: May 2024 --> Oct 2023; Sponsor Decision Trial completion date: Dec 2023 --> Nov 2025 | Trial primary completion date: Dec 2022 --> Nov 2023
- |||||||||| acapatamab (AMG 160) / Amgen, BeiGene
Phase classification: Study of AMG 160 in Subjects With Non-Small Cell Lung Cancer (clinicaltrials.gov) - Dec 20, 2023 P1, N=3, Terminated, Trial completion date: Dec 2023 --> Nov 2025 | Trial primary completion date: Dec 2022 --> Nov 2023 Phase classification: P1b --> P1
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, Vectibix (panitumumab) / Amgen, Takeda
Journal: Prolonging the stability of cetuximab (Erbitux (Pubmed Central) - Dec 20, 2023 Our results provide additional rationale to the SmPCs, crucial especially in the case of reassignment and pre-preparation of bags. This information will allow hospitals to achieve significant cost savings, and better organization of the entire therapeutic process.
- |||||||||| ivabradine / Generic mfg.
Trial completion: PROBE-IT: Pulse Reduction On Beta-blocker and Ivabradine Therapy (clinicaltrials.gov) - Dec 20, 2023 P4, N=28, Completed, Fatigue VAS could act as a simple alternative to more complex methods to measure HRQoL; however, further analyses are required to confirm this association. Active, not recruiting --> Completed
- |||||||||| Tepezza (teprotumumab) / Roche, Amgen
Clinical: Refractory Thyroid Eye Disease Unresponsive to Teprotumumab: A Case Report. (Pubmed Central) - Dec 19, 2023 While teprotumumab has been shown to be efficacious, our patient with TSHRAb-positive euthyroid thyroid-associated ophthalmopathy who presented with diplopia did not have any significant improvement following the standard treatment dose of eight infusions over a 24-week period. This case underscores not only barriers to treatment, such as the high cost of teprotumumab but also highlights the importance of identifying risks for nonresponse.
- |||||||||| Stivarga (regorafenib) / Bayer
Journal: A feedback loop of PPP and PI3K/AKT signal pathway drives regorafenib-resistance in HCC. (Pubmed Central) - Dec 19, 2023 This case underscores not only barriers to treatment, such as the high cost of teprotumumab but also highlights the importance of identifying risks for nonresponse. Taken together, a feedback loop of PPP and PI3K/AKT signal pathway drives regorafenib-resistance in HCC and targeting the feedback loop could be a promising approach to overcome drug resistance.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Review, Journal: The Sequential Therapy in Osteoporosis. (Pubmed Central) - Dec 18, 2023 Despite the absence of fracture data substantiating the implementation of integrated anabolic/antiresorptive pharmacotherapy, the incorporation of denosumab and teriparatide presents a potential avenue worthy of consideration for individuals at a heightened vulnerability to fragility fractures. A judiciously implemented sequential treatment strategy in osteoporosis offers a flexible and tailored approach to address diverse clinical scenarios, optimizing fracture prevention and patient outcomes.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Clinical guideline, Review, Journal: A Review of Various Clinical Practice Guidelines on Osteoporosis in the Last 5 Years. (Pubmed Central) - Dec 18, 2023 The key agents recommended include Bisphosphonates, Teriparatide, Denosumab, SERMs, Hormone Replacement Therapy, and other agents including any drug holidays and duration of therapy. This review identified some key recommendations from CPGs from multiple nations in each of the above given aspects of osteoporosis.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal, Combination therapy: Combination Therapy of Denosumab and Teriparatide in Osteoporosis. (Pubmed Central) - Dec 18, 2023 The categories of drugs that are currently being used for osteoporosis are antiresorptives such as oral and intravenous bisphosphonates, denosumab, and anabolics like teriparatide. This article will focus on the combination therapy of denosumab and teriparatide and will discuss how this combination is better than other class of drugs when given alone or in combination in osteoporosis patients especially those who are at high risk of fragility fractures.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Glucocorticoid-Induced Osteoporosis (GIOP). (Pubmed Central) - Dec 18, 2023 Institution of proper therapeutic management as per WHO risk stratification with anabolic and/or resorptive drugs like bisphosphonates, teriparatide or denosumab is necessary to prevent the eventuality of fragility fractures. Even otherwise, knowledge of glucocorticoid, its metabolism, various dose schedules, adverse effects are areas worth discussing.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Biologic Antiresorptive: Denosumab. (Pubmed Central) - Dec 18, 2023 Therefore, modification to another anti-osteoporosis drug therapy after denosumab discontinuation is required to maintain bone health. Denosumab is a promising biological antiresorptive therapy for osteoporosis that offers high efficacy and safety, but also poses challenges for long-term management.
- |||||||||| Ibrance (palbociclib) / Pfizer
Journal, Patient reported outcomes: Patient-reported outcomes in high-risk HR+ (Pubmed Central) - Dec 18, 2023 Patient-reported global QoL and fatigue did not substantially change in both treatment arms. Slight differences in GHS, physical functioning, and fatigue favored the placebo arm statistically without achieving clinically meaningful thresholds.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal: Micropetrosis: Osteocyte Lacunar Mineralization in Aging and Disease. (Pubmed Central) - Dec 18, 2023 Denosumab and bisphosphonates seem to affect lacunar mineralization differently, where specifically bisphosphonates have been shown to prolong osteocyte viability and reduce micropetrosis. Despite continuous proceedings in the field of osteocyte-lacunar-network characteristics, more studies are necessary to further clarify the mechanisms of lacunar mineralization, the inter-site variability of micropetrosis accumulation, the relevance of micropetrosis in various diseases and conditions, and whether micropetrosis could be an indicator of bone fragility or a target for treatment.
- |||||||||| brazikumab (AMG 139) / AstraZeneca
Biomarker, Journal: Combining Pharmacometric Models with Predictive and Prognostic Biomarkers for Precision Therapy in Crohn's Disease: A Case Study of Brazikumab. (Pubmed Central) - Dec 18, 2023 We demonstrated that model derived IB (baseline biomarker levels that achieve 50% of I ) of 22.8 pg/mL and 8.03 mg/L for BIL22 and BCRP as the cutoffs to select subpopulations can effectively identify high-response sub-group patients with improved separation of responders when compared to using the median values as the cutoff. This work exemplifies the utility of pharmacometrics to quantify biomarker-driven responses in biologic therapies and distinguish between predictive and prognostic biomarkers, complementing clinical efforts of identifying subpopulations with higher likelihood of response to brazikumab.
- |||||||||| Ibrance (palbociclib) / Pfizer
Enrollment closed, Surgery: WI223281: Preoperative Palbociclib in Patients With DCIS of the Breast That Are Candidates for Surgery (clinicaltrials.gov) - Dec 18, 2023 P2, N=17, Active, not recruiting, This work exemplifies the utility of pharmacometrics to quantify biomarker-driven responses in biologic therapies and distinguish between predictive and prognostic biomarkers, complementing clinical efforts of identifying subpopulations with higher likelihood of response to brazikumab. Recruiting --> Active, not recruiting
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Journal: A Proximity-Dependent Biosensor System for Visualizing Cell-Cell Interactions Induced by Therapeutic Antibodies. (Pubmed Central) - Dec 17, 2023 The system was applied to quantitatively monitor cell-cell interactions between NK and target cells induced by rituximab and between T and target cells induced by blinatumomab in a 3D cell culture system. The biosensor system has the potential to characterize antibody pharmacology through a deeper understanding of antibody-mediated cell-cell interactions.
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