- |||||||||| Xofigo (radium Ra-223 dichloride) / Bayer
Review, Journal: Prostate Cancer, Pathophysiology and Recent Developments in Management: A Narrative Review. (Pubmed Central) - Nov 20, 2024
Metastatic castration-resistant prostate cancer treatments include sipuleucel-T, radium-223, abiraterone, enzalutamide and cabazitaxel, which aim to slow down the progression of the disease and to prolong life...In addition, new clinical trials are ongoing to test new medications such as cabozantinb and chimeric-antigen receptor T-cell therapy for the treatment of advanced prostate cancer. With the aim to slow down the progression of the disease and to prolong life, new drug developments are underway to hopefully provide a positive impact on overall survival and improve progression-free survival, especially in advanced prostate cancer.
- |||||||||| Zyclara (imiquimod) / Mochida, Viatris, Bausch Health
Journal: LGR4 Deficiency Aggravates Skin Inflammation and Epidermal Hyperplasia in Imiquimod-Induced Psoriasis. (Pubmed Central) - Nov 20, 2024
Specifically, Lgr4 knockout promoted the secretion of inflammatory factors, accumulation of local immunocyte infiltration in skin lesions, and keratinocyte proliferation. In conclusion, we demonstrated that LGR4 is critical to limiting psoriasis progression, suggesting that it is a viable target for the clinical management of this skin condition.
- |||||||||| Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health
Preclinical, Journal: Rifaximin curative effect and mechanism on monocrotaline-induced hepatic sinusoidal obstruction syndrome in mice (Pubmed Central) - Nov 20, 2024
Simultaneously, the expressions of gut tight junction proteins ZO-1 and Occludin showed an upward trend and validated transcription levels compared to the model group following rifaximin intervention (P<0.05). Rifaximin can alleviate monocrotaline-induced hepatic sinusoidal obstruction syndrome in mice, and its mechanism may be via gut microbiota regulation, which in turn plays a role in improving intestinal barrier function.
- |||||||||| Luzu (luliconazole) / Bausch Health
Journal: Deep Dermal Dilemma: A Case Report on Majocchi's Granuloma After Topical Steroid Use. (Pubmed Central) - Nov 19, 2024
Fungal culture was performed, which showed growth of Trichophyton rubrum. The patient was started on oral terbinafine 250 mg once daily and topical luliconazole cream twice daily topical application, which resolved the lesions in three weeks, but the patient was advised to continue the treatment for a total duration of two months.
- |||||||||| Zyclara (imiquimod) / Mochida, Viatris, Bausch Health
Journal, PD(L)-1 Biomarker, IO biomarker: On-demand reprogramming of immunosuppressive microenvironment in tumor tissue via multi-regulation of carcinogenic microRNAs and RNAs dependent photothermal-immunotherapy using engineered gold nanoparticles for malignant tumor treatment. (Pubmed Central) - Nov 18, 2024
The SNAs@CCMR consisted of antisense oligonucleotides grafted gold nanoparticles (SNAs) as core and TLR7 agonist imiquimod (R837) functionalized cancer cell membrane (CCM) as shell, in which the acid-labile Schiff base bond was used to connect the R837 and CCM...These chain processes not only damaged the primary tumor, but also produced plenty of tumor-associated antigens, which matured the surrounding dendritic cells (DCs) and activated anti-tumor T cells along with the released R837, resulting in the enhanced immunotherapy with suppressive immune escape. Both in vivo and in vitro experiments demonstrated that our nanoparticles were able to inhibit primary tumor and its metastasis via multi-regulation of carcinogenic microRNAs and RNAs dependent photothermal-immune activations, which provided a promising strategy to reprogram the immunosuppressive microenvironment in tumor tissue for better malignant tumor therapy.
- |||||||||| Zyclara (imiquimod) / Mochida, Viatris, Bausch Health
Journal: Novel Therapeutic Approach for Psoriasis: Upregulating FcRn to Inhibit Ferroptosis and Alleviate Lesional skin. (Pubmed Central) - Nov 16, 2024
In an imiquimod (IMQ)-induced psoriasis-like mouse model, FcRn expression was significantly decreased in the lesional skin, and transcriptome sequencing of the skin revealed activation of the ferroptosis pathway in psoriasis...The administration of 1,4-naphthoquinone(NQ), an FcRn agonist, effectively alleviated psoriasis-like skin lesions by inhibiting ferroptosis. This study highlights the molecular mechanisms of action of FcRn in psoriasis and provides an experimental basis for the development of novel therapeutic strategies targeting FcRn.
- |||||||||| Zyclara (imiquimod) / Mochida, Viatris, Bausch Health
Journal: Ultrasound-compatible 3D-printed Franz diffusion system for sonophoresis with microbubbles. (Pubmed Central) - Nov 16, 2024
To overcome this limitation, we designed and manufactured a novel Franz cell donor compartment coupled with a conventional glass receptor, and performed a functional characterisation of the assembly for application in sonophoresis with ultrasound-responsive agents (specifically imiquimod-loaded gas microbubbles)...Moreover, a predictable ultrasound field could be generated at a target surface without any significant spatial distortion. Finally, we demonstrated applicability of the developed assembly in sonophoresis experiments with StratM
- |||||||||| Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health
Review, Journal: Management of hepatic encephalopathy: A general review (Pubmed Central) - Nov 15, 2024
Management is essentially based on treatment of triggering factors such as ionic disorders or sepsis, and symptomatic therapy with non-absorbable disaccharides (notably lactulose) or polyethylene glycol, possibly combined with rifaximin. Progression varies according to the initial severity and management of hepatic encephalopathy, but this condition is potentially reversible with treatment.
- |||||||||| Climara (estradiol) / Bausch Health, Bayer
Trial completion, Trial completion date, Trial primary completion date: CLEAR-3: Cyclical Neuroactive Steroid Changes, Arousal, and Proximal Suicide Risk: An Experimental Approach (clinicaltrials.gov) - Nov 15, 2024
P4, N=90, Completed,
However, it should be avoided in psoriasis patients with renal dysfunction treated with MTX. Active, not recruiting --> Completed | Trial completion date: Feb 2025 --> Aug 2024 | Trial primary completion date: Dec 2024 --> Aug 2024
- |||||||||| Zolinza (vorinostat) / Merck (MSD), Zyclara (imiquimod) / Mochida, Viatris, Bausch Health, Ojjaara (momelotinib) / GSK
Journal, Epigenetic controller: Discovery of Janus Kinase and Histone Deacetylase Dual Inhibitors as a New Strategy to Treat Psoriasis. (Pubmed Central) - Nov 14, 2024
Importantly, compound 11i significantly ameliorated psoriasis-like skin lesions in an imiquimod-induced murine model with low toxicity, which was superior to JAK inhibitor momelotinib, HDAC inhibitor vorinostat, and their combination. This work provided a proof-of-concept for JAK/HDAC dual inhibitors as a promising strategy for the treatment of psoriasis.
- |||||||||| Zyclara (imiquimod) / Mochida, Viatris, Bausch Health
Journal: The DNA sensor AIM2 mediates psoriasiform inflammation by inducing type 3 immunity. (Pubmed Central) - Nov 13, 2024
We found elevated levels of mitochondrial DNA in patients with psoriasis, along with high expression of AIM2 in both the human psoriatic epidermis and a mouse model of psoriasis induced by topical imiquimod (IMQ) application...Finally, the genetic absence of inflammasome components downstream AIM2, ASC, and caspase-1 alleviated IMQ-induced skin inflammation. Collectively, our data show that AIM2 is involved in developing psoriasis through its canonical activation.
- |||||||||| Zyclara (imiquimod) / Mochida, Viatris, Bausch Health
Preclinical, Journal: Matrix metalloproteinase landscape in the imiquimod-induced skin inflammation mouse model. (Pubmed Central) - Nov 13, 2024
Specifically, the changes in the MMP profiles observed in the IMQ-treated skin resemble the MMP patterns found in skin lesions of individuals with psoriasis. Ultimately, the differences in MMP abundance under IMQ-induced inflammation as compared to non-inflamed control skin can be exploited as a model to investigate drug efficacy or performance of drug delivery systems.
- |||||||||| Zyclara (imiquimod) / Mochida, Viatris, Bausch Health
Trial completion date: Topical Aldara (Imiquimod) for Oral Cancer (clinicaltrials.gov) - Nov 12, 2024
P1, N=15, Active, not recruiting,
MiR-6785-5p inhibits the abnormal proliferation and inflammatory state of keratinocytes by reducing MNK2 expression and interfering with the MNK2/p-eIF4E axis. Trial completion date: Sep 2024 --> Dec 2024
- |||||||||| Zyclara (imiquimod) / Mochida, Viatris, Bausch Health
Journal: Polydopamine Nanoformulations Induced ICD and M1 Phenotype Macrophage Polarization for Enhanced TNBC Synergistic Photothermal Immunotherapy. (Pubmed Central) - Nov 7, 2024
PDA nanoparticles are loaded with the insoluble immune adjuvant Imiquimod (R837) to construct PDA(R837) nanoformulations...Furthermore, PDA(R837) nanoformulations inhibit tumor metastasis and recurrence and achieve M1 phenotype macrophage polarization, achieving long-term and excellent antitumor efficacy. Therefore, the structurally simple PDA(R837) nanoformulations provide cancer treatment and have excellent clinical translational application prospects.
- |||||||||| Cesamet (nabilone) / Bausch Health, Viatris
PSYCHEDELICS AND CANNABINOIDS IN THE TREATMENT OF OCD: A REVIEW OF THE CURRENT EVIDENCE (Hall - Olmeca 3) - Nov 7, 2024 - Abstract #WPA2024WPA_661;
A small RCT (n=11) in moderate-to-severe OCD reported that nabilone (a synthetic form of THC) as an add-on to exposure and response prevention (ERP) therapy was superior to nabilone alone (level 4) [560]...Further research is needed to understand safety, tolerability, and efficacy of using psilocybin in patients with TR-OCD. Due to safety concerns about using psilocybin outside of a structured treatment setting, we are unable to make a recommendation at this time.
- |||||||||| Zyclara (imiquimod) / Mochida, Viatris, Bausch Health
Enrollment change, Trial termination: Comparing Immune Responses to Topical Imiquimod (clinicaltrials.gov) - Nov 7, 2024
P=N/A, N=6, Terminated,
Due to safety concerns about using psilocybin outside of a structured treatment setting, we are unable to make a recommendation at this time. N=110 --> 6 | Active, not recruiting --> Terminated; PI failed to submit the study for continuing review to IRB, failed to respond.
- |||||||||| Siliq (brodalumab) / Bausch Health, Humira (adalimumab) / AbbVie
Induction Cost Per Responder of Brodalumab Compared With Other Biologic Therapies for Patients With Moderate to Severe Plaque Psoriasis in Canada () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_3175;
The CPR was estimated as the drug acquisition costs during the induction period multiplied by the number needed to treat (NNT) for achieving PASI 75, 90, or 100 for the following treatments: adalimumab (innovator and SEB), brodalumab, bimekizumab, certolizumab pegol, etanercept (innovator and SEB), guselkumab, infliximab (innovator and SEB), ixekizumab, risankizumab, secukinumab, tildrakizumab, ustekinumab (innovator and SEB). These results demonstrate that brodalumab has the lowest induction CPR across all PASI outcomes compared to other biologic therapies, including SEB therapies, thus providing the best value for money for patients, prescribers, and payers.
- |||||||||| Zyclara (imiquimod) / Mochida, Viatris, Bausch Health
Economic Evaluation of Intradermal Hepatitis B Vaccination Plus Imiquimod Pretreatment for Dialysis Patients () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_1839;
These results demonstrate that brodalumab has the lowest induction CPR across all PASI outcomes compared to other biologic therapies, including SEB therapies, thus providing the best value for money for patients, prescribers, and payers. Intradermal administration of HBV Sci-B-Vac plus imiquimod pretreatment appears to be a cost-effective strategy for serologically negative dialysis patients.
- |||||||||| Zyclara (imiquimod) / Mochida, Viatris, Bausch Health, tirbanibulin oral (KX2-391 oral) / Athenex
Pain and Lesion Count in the Clinical Management of Actinic Keratosis in the Real-World Setting () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_981;
Results provide insights into the roles of pain and lesion count in the management of AK patients in the real-world dermatology setting. Analyses of clinical notes may be beneficial to understand reasons behind different clinical management strategies.
- |||||||||| Siliq (brodalumab) / Bausch Health, Cosentyx (secukinumab) / Novartis
Journal: Interleukin-17 inhibitors for the management of severe rosacea. (Pubmed Central) - Nov 4, 2024
Analyses of clinical notes may be beneficial to understand reasons behind different clinical management strategies. No abstract available
- |||||||||| Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health
Journal: Protein engineering of an alkaline protease from Bacillus licheniformis (BLAP) for efficient and specific chiral resolution of the racemic ethyl tetrahydrofuroate. (Pubmed Central) - Nov 4, 2024
In this study, the point-saturation-mutation libraries based on the seven amino acid sites (L105, I113, P114, L115, V309, Y310, and M326) were constructed and screened using the molecular docking technology...The enantiomeric ratio of BLAPY310E was 105.5, which was 30.23 times higher than that of BLAP. This study advances the comprehension of protease activity and selectivity mechanisms in resolving ester substances and lays a robust foundation for the industrial production of the optically pure (S)-2-ethyl tetrahydrofuroate and (R)-2-tetrahydrofuroic acid via biological enzymatic methods.
- |||||||||| dexanabinol (ETS2101) - e / therap, Ceska Lekarnicka, Cesamet (nabilone) / Bausch Health, Viatris
Clinical, Retrospective data, Review, Journal: Cannabinoids Used for Medical Purposes in Children and Adolescents: A Systematic Review and Meta-Analysis. (Pubmed Central) - Nov 4, 2024
In this systematic review and meta-analysis, cannabinoids used for medical purposes in children and adolescents in RCTs were associated with an increased risk of adverse events. The findings suggest that long-term safety studies, including those exploring cannabinoid-related drug interactions and tools that improve adverse event reporting, are needed.
- |||||||||| Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health
Review, Journal: Infection, inflammation and hepatic encephalopathy from a clinical perspective. (Pubmed Central) - Nov 4, 2024
A perturbed gut microbiome and the presence of an impaired gut epithelial barrier that facilitates translocation of bacteria and bacterial degradation products into the systemic circulation, inducing systemic inflammation and innate and adaptive immune dysfunction, has now become the focus of therapies that treat hepatic encephalopathy in cirrhosis, and may explain why the prebiotic lactulose and rifaximin are efficacious. This review summarises the current clinical perspective on the roles of inflammation and infection in hepatic encephalopathy and presents the evidence base for existing therapies and those in development in the setting of acute and chronic liver failure.
- |||||||||| Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health
Review, Journal: Role of peripheral inflammation in minimal hepatic encephalopathy. (Pubmed Central) - Nov 4, 2024
The contribution of peripheral inflammation to trigger MHE is supported by studies in animal models and by the fact that rifaximin treatment reverses MHE in around 60% of patients in parallel with reversal of the changes in peripheral inflammation...Transmission of peripheral alterations into the brain is mediated by infiltration in brain of extracellular vesicles from plasma and of cells from the peripheral immune system. Acting on any step of the process peripheral inflammation - neuroinflammation - altered neurotransmission may improve MHE.
- |||||||||| Cesamet (nabilone) / Bausch Health, Viatris
Journal: Comparative Safety Analysis of Nabilone Versus Opioids: A Population-Based Cohort Study. (Pubmed Central) - Nov 4, 2024
While usage of nabilone relative to opioids was associated with reduced rates of pneumonia, falls or fractures, and all-cause mortality, it was simultaneously associated with an increased rate of adverse mental health outcomes. This picture of mixed safety results raises concerns with the policy approach of broadly substituting use of opioids with nabilone.
- |||||||||| Zyclara (imiquimod) / Mochida, Viatris, Bausch Health
Journal, Combination therapy: A Novel Triple Combination Therapy for the Treatment of Recalcitrant Plantar Warts: A Case Report. (Pubmed Central) - Nov 4, 2024
This case highlights the synergistic effects of combining physical destruction (cryotherapy), immune modulation (imiquimod), and local immune stimulation (PPD) to successfully treat recalcitrant plantar warts. This triple combination therapy may offer a promising option for cases unresponsive to standard treatments, providing a comprehensive approach that reduces recurrence and promotes complete resolution.
- |||||||||| Jublia (efinaconazole) / Bausch Health, Luzu (luliconazole) / Bausch Health
Journal: Development of treatment strategies by comparing the minimum inhibitory concentrations and minimum fungicidal concentrations of azole drugs in dermatophytes. (Pubmed Central) - Nov 2, 2024
To assess the MICs of ITCZ, ravuconazole (RVCZ), efinaconazole (EFCZ), and luliconazole (LUCZ) in the isolates, broth microdilution assays were performed based on the Clinical and Laboratory Standards Institute M38-A2 guidelines with modifications...The MFCs in the dermatophytes were 1 to >32?mg/L for ITCZ, 0.06 to >32?mg/L for RVCZ, <0.03 to 4?mg/L for EFCZ, and <0.03 to 2?mg/L for LUCZ. If the drug susceptibility test shows that the fungi are resistant to the drug, the treatment can be changed to a susceptible drug in advance, or if the fungi are low-susceptible, the treatment can be done with the recognition that it may require a longer treatment period than usual.
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