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- Safety profile of the add-on combination of Regorafenib with Nivolumab after treatment with atezolizumab-bevacizumab in treated patients with hepatocellular carcinoma (ePoster Area) - Dec 26, 2023 - Abstract #LCS2024LCS_175;
P1/2
This initial data suggests that Rego-Nivo can be safely administered. Final analysis including efficacy results will be presented later.
- Cyramza (ramucirumab) / Eli Lilly, Stivarga (regorafenib) / Bayer, Cabometyx (cabozantinib tablet) / Exelixis, Ipsen
Update in systemic therapies for hepatocellular carcinoma (Plenary) - Dec 26, 2023 - Abstract #LCS2024LCS_148;
There are no meaningful differences in efficacy for any of these drugs evaluated in the 2nd setting and the best treatment sequences of the available drugs have not been established. Learning objectives - Understand endpoints in clinical trials and its implication for daily decision making.- Learning about the latest developments in the systemic therapies in early and advanced stage HCC.- Finding out about the most recent criteria for selection of systemic therapies- Gaining insight in clinical and molecular biomarkers for systemic therapies
- Ibrance (palbociclib) / Pfizer
Aptamers targeting HuR SUMOylation as a potential therapy for liver cancer (ePoster Area) - Dec 26, 2023 - Abstract #LCS2024LCS_142;
Moreover, aptamer treatment increased sensitivity to palbociclib. All these findings highlight the potential of aptamers targeting HuR SUMOylation as a novel targeted and specific therapeutic approach for liver cancer.
- Stivarga (regorafenib) / Bayer
Modeling cancer cells and tumor vasculature dynamics by serum biomarkers in HCC patients with different response to TKIs, TACE and TARE suggests a synergistic effect of systemic and endovascular treatments (ePoster Area) - Dec 26, 2023 - Abstract #LCS2024LCS_59;
Their different modes of action are captured by the model, suggesting a synergic effects of TKIs and endovascular treatments. Future trials could assess whether model tailored schedules increase therapeutic efficacy.
- | Stivarga (regorafenib) / Bayer
Retrospective data, Journal: Appropriate dose of regorafenib based on body weight of colorectal cancer patients: a retrospective cohort study. (Pubmed Central) - Dec 26, 2023
The findings suggest that a low dose of regorafenib for light-weight patients may be as safe and effective as high doses for heavy-weight patients. Further studies should be conducted to identify an appropriate dose based on each patient's physique and condition.
- | Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Transient osteoporosis of the hip following discontinuation of denosumab and switch to alendronate treatment. (Pubmed Central) - Dec 26, 2023
Further studies should be conducted to identify an appropriate dose based on each patient's physique and condition. No abstract available
- || Tezspire (tezepelumab-ekko) / AstraZeneca, Amgen
Review, Journal: Tezepelumab in patients with allergic and eosinophilic asthma. (Pubmed Central) - Dec 26, 2023
P2, P3
In a pooled analysis of the phase 2b PATHWAY (NCT02054130) and phase 3 NAVIGATOR (NCT03347279) studies, compared with placebo, tezepelumab reduced the annualized asthma exacerbation rate over 52?weeks by 62% (95% confidence interval [CI]: 53, 70) in patients with perennial aeroallergen sensitization (allergic asthma); by 71% (95% CI: 62, 78) in patients with a baseline blood eosinophil count ?300 cells/?L; and by 71% (95% CI: 59, 79) in patients with allergic asthma and a baseline blood eosinophil count ?300 cells/?L. This review examines the efficacy and mode of action of tezepelumab in patients with allergic asthma, eosinophilic asthma and coexisting allergic and eosinophilic phenotypes.
- || brazikumab (AMG 139) / AstraZeneca
P2a data, Journal: Long-term safety of brazikumab in the open-label period of a randomized phase 2a study of patients with Crohn's disease. (Pubmed Central) - Dec 25, 2023
P2a
Brazikumab was well tolerated with an acceptable safety profile over a 100-week period in patients with moderate-to-severe active CD who failed or were intolerant to 1 or more anti-TNF? agents.
- || Prolia (denosumab) / Amgen, Daiichi Sankyo
Review, Journal, Real-world evidence, Real-world: Methodological guidance for the use of real-world data to measure exposure and utilization patterns of osteoporosis medications. (Pubmed Central) - Dec 25, 2023
Finally, we present considerations for the measurement of osteoporosis medication exposure, adherence, switching, long-term exposures, and drug holidays using RWD. Ultimately, a thorough understanding of the differences in RWD sources and the pharmacology of osteoporosis medications is essential to obtain valid estimates of the relationship between osteoporosis medications and outcomes, such as fractures, but also to improve the critical appraisal of published studies.
- | Enbrel (etanercept) / Pfizer, Amgen, Humira (adalimumab) / AbbVie
Journal, Real-world evidence, Real-world: Real-World Health Care Outcomes and Costs Among Patients With Juvenile Idiopathic Arthritis in Spain. (Pubmed Central) - Dec 25, 2023
JIA causes significant costs to the Spanish healthcare system and affected families. Public costs are partly due to the high cost of biologic treatments, which nevertheless remain an effective long-term treatment, maintaining inactive disease/low disease activity state; a very low functional disability score; and a good quality of life.
- | Tagrisso (osimertinib) / AstraZeneca, Vectibix (panitumumab) / Amgen, Takeda
Journal: Anti-epidermal growth factor receptor targeted therapy-associated ulcerations. (Pubmed Central) - Dec 25, 2023
Oral adverse events due to those agents are rarely described in the literature and their exact characterization is hampered by inadequate reporting and/or incorrect terminology used. We report two cases of panitumumab- and osimertinib-associated oral ulcerations with emphasis on their possible pathogenesis and optimal management.
- | Ibrance (palbociclib) / Pfizer
Journal, Metastases: Measures of functional status in older patients treated with palbociclib for advanced breast cancer. (Pubmed Central) - Dec 25, 2023
P=N/A
In this subgroup analysis of older patients with ABC from POLARIS, functional status and impairment outcomes were preserved in older patients receiving palbociclib. G8, ADL, and ECOG PS scores were generally maintained during the first six months of palbociclib therapy.
- | Tepezza (teprotumumab) / Roche, Amgen
Journal: Efficacy and Safety of Teprotumumab in Thyroid Eye Disease Patients with Long Duration and Low Disease Activity. (Pubmed Central) - Dec 25, 2023
Teprotumumab significantly improved proptosis vs placebo in longstanding/low inflammation TED, demonstrating efficacy regardless of disease duration/activity. The safety profile was comparable to that previously reported.
- || omecamtiv mecarbil (AMG 423) / Amgen, Servier
Review, Journal: Differentiating Cardiac Troponin Levels During Cardiac Myosin Inhibition or Cardiac Myosin Activation Treatments: Drug Effect or the Canary in the Coal Mine? (Pubmed Central) - Dec 25, 2023
In patients with HFrEF, cardiac myosin activator (omecamtiv mecarbil) therapy cause modest increases in cardiac troponin levels which are reversible following treatment cessation and not associated with myocardial ischaemia or infarction...Longitudinal changes in troponin levels vary depending on the population and treatment. Further research is needed to elucidate mechanisms underlying changes in troponin levels.
- | Solymbic (adalimumab biosimilar) / Amgen, Amjevita (adalimumab-atto) / Amgen, Daiichi Sankyo, Eticovo (etanercept-ykro) / Biogen, Organon, Samsung, Ewopharma, Yuhan Corp, Mundipharma
Journal: Anti-tumor necrosis factor ?: originators versus biosimilars, comparison in clinical response assessment in a multicenter cohort of patients with inflammatory arthropathies. (Pubmed Central) - Dec 24, 2023
Real-life data demonstrated a similar safety profile between biosimilars and originators, but a reduced biosimilar retention rate at 24 months. Biosimilars could be considered a valid, safe, and less expensive alternative to originators, allowing access to treatments for a wider patient population.
- | Stivarga (regorafenib) / Bayer
Journal, Metastases: Regorafenib therapy as a third-line treatment for metastatic colorectal cancer: A single center long term experience. (Pubmed Central) - Dec 24, 2023
Biosimilars could be considered a valid, safe, and less expensive alternative to originators, allowing access to treatments for a wider patient population. The mPFS contribution in the BRAF mutant subgroup with poor prognosis is promising, as it is similar to that of patients without BRAF mutations (4 months?
- | Lumakras (sotorasib) / Amgen
Pricing, Journal, HEOR, Cost-effectiveness, Cost effectiveness, Metastases: Sotorasib versus Docetaxel for treatment of US and Chinese patients with advanced non-small-cell lung cancer with KRAS p.G12C-mutated: A cost-effectiveness analysis to inform drug pricing. (Pubmed Central) - Dec 24, 2023
Our evidence-based pricing strategy can assist decision-makers and clinicians in making optimal decisions. However, further analysis of budget impact and affordability is needed.
- | Neupogen (filgrastim) / Kyowa Kirin, Amgen, hydroxyurea / Generic mfg.
Journal: Sweet Syndrome: Clinical Presentation, Malignancy Association, Autoinflammatory Disorders and Treatment Response in a Cohort of 93 Patients with Long-term Follow-up. (Pubmed Central) - Dec 23, 2023
However, further analysis of budget impact and affordability is needed. The most frequent associated medications and inflammatory
- | SB202190 / Amgen, ralimetinib (LY 2228820) / Eli Lilly
Journal, Tumor cell: p38 Mitogen-Activated Protein Kinase Inhibition of Mesenchymal Transdifferentiated Tumor Cells in Head and Neck Squamous Cell Carcinoma. (Pubmed Central) - Dec 23, 2023
In accordance, p-p38 inhibition led to sensitization of pEMT cells to cisplatin-induced cell death; moreover, p-p38 inhibitor treatment cycles significantly decreased the viability of cisplatin-surviving cells. In conclusion, clinically relevant p38 inhibitors might be effective for RCT-resistant pEMT cells in HNSCC patients.
- | Repatha (evolocumab) / Amgen, Astellas
Journal: Sex X Time Interactions in Lp(a) and LDL-C Response to Evolocumab. (Pubmed Central) - Dec 23, 2023
Our data partially reinforce the presence of differences in response to treatment to PCSK9i between men and women and are essential to gain a better understanding of the relationship between LDL-C and Lp(a) lowering in response to PCSK9i. Further research will clarify whether these sex-related significant differences translate into a meaningful difference in the long-term risk of ASCVD.
- || Iclusig (ponatinib) / Takeda, Otsuka, Incyte, Blincyto (blinatumomab) / Astellas, Amgen
Review, Journal: How to Manage Philadelphia-Positive Acute Lymphoblastic Leukemia in Resource-Constrained Settings. (Pubmed Central) - Dec 23, 2023
Blinatumomab, a bispecific antibody, has shown significant synergy with TKIs in treating this disease. It serves as an excellent salvage therapy, aside from achieving outstanding results when incorporated into the frontline.
- | Lonsurf (trifluridine/tipiracil) / Servier, Otsuka, Stivarga (regorafenib) / Bayer
Retrospective data, Journal, Real-world evidence, Real-world, Metastases: Retrospective Correlation between First Drug Treatment Duration and Survival Outcomes in Sequential Treatment with Regorafenib and Trifluridine/Tipiracil in Refractory Metastatic Colorectal Cancer: A Real-World Subgroup Analysis. (Pubmed Central) - Dec 23, 2023
There were no statistically significant differences between groups with first drug treatment durations of <3 months and ?6 months. Our analysis seems to suggest that the administration of R for a period of 3 to <6 months before that of T can prolong both OS and PFS, as compared to the opposite sequence.
- || Blincyto (blinatumomab) / Astellas, Amgen
Retrospective data, Review, Journal, CAR T-Cell Therapy: Comparison of blinatumomab and CAR T-cell therapy in relapsed/refractory acute lymphoblastic leukemia: a systematic review and meta-analysis. (Pubmed Central) - Dec 23, 2023
An emerging role for blinatumomab is as a bridging agent pre-SCT and for patients who achieve an MRD-negative state pre-SCT, post-SCT outcomes are expected to be the same as CAR-T. For adverse effects (AEs), blinatumomab was associated with a lower rate of grade???3 hematological toxicity, CRS, and neurological events.
- | Blincyto (blinatumomab) / Astellas, Amgen
Journal: Blinatumomab as bridging therapy in two children with B-cell acute lymphoblastic leukemia complicated by invasive fungal disease (Pubmed Central) - Dec 23, 2023
After antifungal and blinatumomab therapy, both cases showed significant improvement in symptoms, signs, and imaging, and B-ALL remained in continuous remission. The report indicates that bridging treatment with blinatumomab in children with B-ALL complicated by IFD can rebuild the immune system and control the underlying disease in the presence of immunosuppression and severe fungal infection.
- | Krystexxa (pegloticase) / Amgen, Elitek (rasburicase) / Sanofi, PAT-101 / Pasithea
Preclinical, Journal: In vivo study of newly developed albumin-conjugated urate oxidase for gout treatment. (Pubmed Central) - Dec 23, 2023
The report indicates that bridging treatment with blinatumomab in children with B-ALL complicated by IFD can rebuild the immune system and control the underlying disease in the presence of immunosuppression and severe fungal infection. All results suggest that this rHA-conjugated AfUox, PAT101, can be provided as a reliable source of Uox for gout treatment.
- | Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Effect of denosumab on glucose metabolism in postmenopausal osteoporotic women with prediabetes: a study protocol for a 12-month multicenter, open-label, randomized controlled trial. (Pubmed Central) - Dec 23, 2023
This study aims to provide evidence on the efficacy of denosumab on glucose metabolism in postmenopausal women with osteoporosis and prediabetes. The results derived from this clinical trial may provide insight into the potential of denosumab in preventing T2D in high-risk populations.
- | Zyclara (imiquimod) / Mochida, Viatris, Bausch Health, Enbrel (etanercept) / Pfizer, Amgen
Journal, PD(L)-1 Biomarker, IO biomarker: In situ production and secretion of proteins endow therapeutic benefit against psoriasiform dermatitis and melanoma. (Pubmed Central) - Dec 22, 2023
An SP-engineered anti-PD-L1 construct mediated mRNA encoded proteins with longer serum half-lives that reduced tumor burden and extended survival in MC38 and B16F10 cancer models. The modular nature of SP platform should enable intracellular and extracellular localization control of various functional proteins for diverse therapeutic applications.
- ||| Nplate (romiplostim) / Amgen, Kyowa Kirin
P2/3 data, Journal: Long-term efficacy and safety of romiplostim in refractory aplastic anemia: follow-up of a phase 2/3 study. (Pubmed Central) - Dec 22, 2023
The modular nature of SP platform should enable intracellular and extracellular localization control of various functional proteins for diverse therapeutic applications. No abstract available
- || Ajovy (fremanezumab) / Otsuka, Teva, Botox (onabotulinumtoxin A) / GSK, AbbVie, Healis Therap, Aimovig (erenumab-aooe) / Amgen, Novartis
Review, Journal: Treatment Options for Posttraumatic Headache: A Current Review of the Literature. (Pubmed Central) - Dec 22, 2023
A randomized crossover study of 40 patients with persistent PTH found that onabotulinum toxin-A decreased cumulative number of headaches/week by 43.3% in the treatment group and increased by 35.1% among placebos...New studies indicate promise in improving clinically important outcomes of PTH. However, more research is necessary to determine the optimal treatment and whether combining pharmacologic and nonpharmacologic treatment versus a single modality is more effective.
- || Iclusig (ponatinib) / Takeda, Otsuka, Incyte, Blincyto (blinatumomab) / Astellas, Amgen, Tasigna (nilotinib) / Novartis, Inhibikase
Review, Journal: Low-Intensity and Chemo-Free Treatments in Ph+ ALL: Progression-Free Survival Based on Indirect Comparisons. (Pubmed Central) - Dec 22, 2023
The survival data from these trials were pooled into three types of treatments: (i) treatments based on tyrosine kinase inhibitors (TKIs) combined with reduced-intensity chemotherapy (denoted as TKICHE); (ii) TKIs associated with steroids with no chemotherapy (TKISTE); (iii) chemotherapy-free combinations of blinatumomab plus TKIs (TKIBLI)...In terms of PFS, TKIBLI ranked first, TKICHE second, and TKISTE third; the differences between these three regimens were statistically significant. This multi-treatment Kaplan-Meier graph, generated through the Shiny method, summarized the current evidence on these treatments in both qualitative and quantitative terms.
- | Prolia (denosumab) / Amgen, Daiichi Sankyo
Preclinical, Journal: Anti-Siglec-15 Antibody Prevents Marked Bone Loss after Acute Spinal Cord Injury-Induced Immobilization in Rats. (Pubmed Central) - Dec 22, 2023
Rapid and extensive sublesional bone loss after spinal cord injury (SCI) is a difficult medical problem that has been refractory to available interventions except the antiresorptive agent denosumab (DMAB)...JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research. This article has been contributed to by U.S. Government employees and their work is in the public domain in the USA.
- ||| QL0911 (romiplostim biosimilar) / Qilu Pharma
Clinical, P3 data, Journal: Efficacy and safety of QL0911 in adult patients with chronic primary immune thrombocytopenia: A multicenter, randomized, double-blind, placebo-controlled, phase III trial. (Pubmed Central) - Dec 22, 2023
P3
This article has been contributed to by U.S. Government employees and their work is in the public domain in the USA. QL0911, a biosimilar to romiplostim (Nplate
- | Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal: Fibrous dysplasia in children and its management. (Pubmed Central) - Dec 22, 2023
Management of children with FD has unique challenges related to skeletal growth and age-related lesion progression. Inclusion of children in clinical research is critical to develop effective treatment strategies to treat FD lesions and prevent their development.
- | Ibrance (palbociclib) / Pfizer
Journal: Altering distribution profile of palbociclib by its prodrugs. (Pubmed Central) - Dec 22, 2023
PD1 exhibited a higher AUC ratio, suggesting safer dosing, while PD2 showed favorable long-acting pharmacokinetics. Although our prodrug design did not significantly improve palbociclib brain delivery due to the potential size limitation of the prodrugs, the study provides valuable insights for future prodrug development and drug delivery strategies targeting specific transporters.
- | Uplizna (inebilizumab) / Mitsubishi Tanabe, Amgen, Soliris (eculizumab) / AstraZeneca, Enspryng (satralizumab) / Roche
FDA event, Journal: Utilization of FDA approved treatments for neuromyelitis optica spectrum disorder in clinical practice: A survey study of academic neuroimmunologists. (Pubmed Central) - Dec 22, 2023
Neuromyelitis optica spectrum disorder (NMOSD) is a rare autoimmune condition for which three treatments have been approved since 2019: eculizumab, inebilizumab, and satralizumab. Following relapse, respondents were dichotomized, either switching 75-100
- | Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi, Glassia (alpha1-proteinase inhibitor (Human)) / Takeda
Trial completion, Enrollment change: Multicenter Trial of the Effect of AAT on Islet Transplant Engraftment and Durability After Renal Transplant (clinicaltrials.gov) - Dec 22, 2023
P2, N=2, Completed, Sponsor: Massachusetts General Hospital
Following relapse, respondents were dichotomized, either switching 75-100 Active, not recruiting --> Completed | N=20 --> 2
- | Ibrance (palbociclib) / Pfizer, Mektovi (binimetinib) / Ono Pharma, Pierre Fabre, Pfizer
Enrollment change, Trial withdrawal, Surgery: Binimetinib and Palbociclib Before Surgery for the Treatment of Operable KRAS-Positive Lung, Colorectal, or Pancreatic Cancer (clinicaltrials.gov) - Dec 22, 2023
P1, N=0, Withdrawn, Sponsor: Roswell Park Cancer Institute
Active, not recruiting --> Completed | N=20 --> 2 N=24 --> 0 | Recruiting --> Withdrawn
- | Uplizna (inebilizumab-cdon) / Mitsubishi Tanabe, Amgen
New P4 trial: N-MOmentum LT: Long-term, Open-label, Safety Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD) (clinicaltrials.gov) - Dec 22, 2023
P4, N=30, Not yet recruiting, Sponsor: Horizon Therapeutics Ireland DAC
- || Stivarga (regorafenib) / Bayer
Trial completion, Trial primary completion date, Combination therapy, Metastases: REPROGRAM-01: Regorafenib in Combination With Metronomic Chemotherapies, and Low-dose Aspirin in Metastatic Colorectal Cancer (clinicaltrials.gov) - Dec 22, 2023
P2, N=49, Completed, Sponsor: Centre Hospitalier Universitaire de Besancon
N=24 --> 0 | Recruiting --> Withdrawn Active, not recruiting --> Completed | Trial primary completion date: Jul 2023 --> Dec 2023
- ||||| Keytruda (pembrolizumab) / Merck (MSD), pembrolizumab/berahyaluronidase alfa (MK-3475A) / Merck (MSD)
Enrollment closed: A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77) (clinicaltrials.gov) - Dec 21, 2023
P3, N=339, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Active, not recruiting --> Completed | Trial primary completion date: Jul 2023 --> Dec 2023 Recruiting --> Active, not recruiting
- || efavaleukin alfa (AMG 592) / Amgen
Trial completion date, Trial primary completion date: Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - Dec 21, 2023
P2, N=320, Recruiting, Sponsor: Amgen
Recruiting --> Active, not recruiting Trial completion date: Apr 2025 --> May 2026 | Trial primary completion date: Jun 2024 --> Jul 2025
- Humira (adalimumab) / AbbVie, Yuflyma (adalimumab-aaty) / Celltrion, Hikma
Patient preferences for adalimumab in inflammatory bowel disease: a nationwide study from the GETAID (Poster exhibition) - Dec 21, 2023 - Abstract #ECCOIBD2024ECCO_IBD_1027;
Trial completion date: Apr 2025 --> May 2026 | Trial primary completion date: Jun 2024 --> Jul 2025 Results The most commonly used drugs at inclusion were Humira
- Wezlana (ustekinumab-auub) / Amgen
Pharmacokinetics and immunogenicity of the ustekinumab biosimilar candidate ABP 654 in patients with moderate-to-severe plaque psoriasis (Poster exhibition) - Dec 21, 2023 - Abstract #ECCOIBD2024ECCO_IBD_861;
While the percentages of binding and neutralising ADAs were numerically lower for the ABP 654 group compared with the ustekinumab RP group through Week 28 (and in patients who received dose intensification), the available clinical efficacy, safety, and PK data suggest that these differences were not clinically impactful. Overall, the results support a conclusion of no clinically meaningful differences between ABP 654 and ustekinumab RP.
- brazikumab (AMG 139) / AstraZeneca
Post hoc analysis reveals limited efficacy of induction therapy in ileum only Crohn (Poster exhibition) - Dec 21, 2023 - Abstract #ECCOIBD2024ECCO_IBD_857;
Results A total of 9 studies, involving 709 adult patients, were identified: two via Embase and PubMed; six from supplementary search materials; and one post-hoc analysis of brazikumab data (not published)...Previous systematic review1 on clinical remission after induction treatment demonstrate placebo adjusted values in the range of 12-20% in a no defined disease site population. This indicates the need for novel therapies with a mechanism of action directly tailored to heal the small intestine in patients with CD.
- Hadlima (adalimumab-bwwd) / Organon, Biogen, Samsung, Mundipharma, Yuhan Corp, Humira (adalimumab) / AbbVie
Prospective evaluation of the switch from adalimumab originator to different biosimilars in IBD patients : acceptability and persistance at 1 year. (Poster exhibition) - Dec 21, 2023 - Abstract #ECCOIBD2024ECCO_IBD_792;
This indicates the need for novel therapies with a mechanism of action directly tailored to heal the small intestine in patients with CD. Methods From July 2020 to September 2021, we proposed for consecutive and ambulatory IBD patients on maintenance Humira
- || Ibrance (palbociclib) / Pfizer
PK/PD data, Preclinical, Journal: Design of experiment-oriented development and validation of novel bioanalytical reverse phase high performance liquid chromatography method of palbociclib in rat plasma and tissues, and its application in pharmacokinetic studies. (Pubmed Central) - Dec 21, 2023
The developed bioanalytical method showed greater accuracy (0.98 and 4.01%) and precision (<4.88%). The method was optimized for the sensitive analysis of the PAL in rat plasma, and the kidney, liver, spleen and heart were effectively applied to pharmacokinetic studies.
- ||| Neupogen (filgrastim) / Kyowa Kirin, Amgen
Journal, Adverse events: Update of triggers for detection of adverse drug events in hematologic patients (Pubmed Central) - Dec 21, 2023
The overall PPV of the new suggested list was 48% versus 10% of the previous list. This study demonstrated the importance of an updated list of triggers for the monitoring of ADEs and improvement of the care provided.
- | Ibrance (palbociclib) / Pfizer
Journal: Induced Endothelial Cell CycleArrest Prevents Arteriovenous Malformations in Hereditary Hemorrhagic Telangiectasia. (Pubmed Central) - Dec 21, 2023
Mechanistically, endothelial cell late G1 arrest induced by palbociclib modulates the expression of genes regulating arteriovenous identity, endothelial cell migration, metabolism, and VEGF-A (vascular endothelial growth factor A) and BMP9 signaling that collectively contribute to the prevention of vascular malformations. This study provides new insights into molecular mechanisms leading to HHT by defining how endothelial cell cycle is dysregulated in AVMs because of BMP9/10 and Alk1 signaling deficiencies, and how restoration of endothelial cell cycle control may be used to treat AVMs in patients with HHT.
- || Retrospective data, Review, Metastases: Comparative efficacy and safety of systemic therapy for advanced hepatocellular carcinoma: a systematic review and network meta-analysis. (Pubmed Central) - Dec 21, 2023
In the context of first-line treatment, it was observed that the combination of a PD-1 inhibitor with bevacizumab (1/15) significantly extended overall survival in patients with advanced HCC...However, this translated into an overall survival benefit only for cabozantinib, regorafenib, ramucirumab, and pembrolizumab, with regorafenib achieving the highest ranking (1/7)...For second-line treatment, regorafenib and cabozantinib are identified as the two most effective options. https://www.crd.york.ac.uk/prospero, identifier CRD42023440173.
- | giredestrant (GDC-9545) / Roche
Journal, Metastases: Optimizing Early-Stage Clinical Pharmacology Evaluation to Accelerate Clinical Development of Giredestrant in Advanced Breast Cancer. (Pubmed Central) - Dec 21, 2023
P1
https://www.crd.york.ac.uk/prospero, identifier CRD42023440173. This study illustrates how the integration of clinical pharmacology considerations into early-phase clinical trials can inform the design of pivotal studies and accelerate oncology drug development.