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  • ||||||||||  Xolair (omalizumab) / Roche, Novartis, Onbrez (indacaterol) / Novartis
    Journal:  Drugs for asthma. (Pubmed Central) -  Jan 26, 2021   
    No abstract available
  • ||||||||||  Flutiform (fluticasone/formoterol) / Kyorin, Mundipharma, Vectura, Sanofi
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date:  SWIFT: Efficacy and Safety of Flutiform K-haler in Patients With Uncontrolled Asthma Following Mid-dose ICS/LABA DPI Therapy (clinicaltrials.gov) -  Jan 25, 2021   
    P3,  N=20, Terminated, 
    N=85 --> 20 | Trial completion date: Jun 2021 --> Sep 2020 | Not yet recruiting --> Terminated | Trial primary completion date: Apr 2021 --> Sep 2020; The Contract of K-haler products had been terminated between Mundipharma and provider. Therefore, this clinical trial was terminated early.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Journal:  Hypolipidaemic and Insulin Secretagogue Activities of (R)-(-)-Carvone. (Pubmed Central) -  Jan 16, 2021   
    (R)-(-)-carvone has the advantage over fenofibrate of not producing hypoglycaemia in animals. Furthermore, (R)-(-)-carvone increased proliferation and insulin secretion of human pancreatic β-cells.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Journal:  Solubility of Pharmaceutical Ingredients in Natural Edible Oils. (Pubmed Central) -  Jan 14, 2021   
    In this work, solubilities of indomethacin (IND), ibuprofen (IBU), and fenofibrate (FFB) in soybean oil and in coconut oil were measured via differential scanning calorimetry, high-performance liquid chromatography, and Raman spectroscopy...Furthermore, the solubilities of five more APIs (IND, cinnarizine, naproxen, griseofulvin, and felodipine) were modeled in soybean oil...The influence of different NEO kinds on API solubility was examined by comparing FFB and IBU solubilities in soybean oil and refined coconut oil. PC-SAFT was thus found to allow assessing the batch-to-batch consistency of NEO batches in silico.
  • ||||||||||  Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
    Enrollment open, Adherence:  ADITION: Digital Adherence Monitoring of Inhalative Therapy in Real- Life Conditions (clinicaltrials.gov) -  Jan 13, 2021   
    P=N/A,  N=1000, Recruiting, 
    PC-SAFT was thus found to allow assessing the batch-to-batch consistency of NEO batches in silico. Not yet recruiting --> Recruiting
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Journal:  Phase behavior of ASDs based on hydroxypropyl cellulose. (Pubmed Central) -  Jan 8, 2021   
    As predicted, the ASDs with higher drug load underwent amorphous phase separation according to the differential scanning calorimetry thermograms. This work thus showed that it is possible to predict critical drug loads above which amorphous phase separation and/or crystallization occurs in HPC ASDs.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Journal:  Fixed dose combinations for cardiovascular treatment via coaxial electrospraying: coated amorphous solid dispersion particles. (Pubmed Central) -  Jan 6, 2021   
    In this work, the feasibility of coaxial electrospraying (CES) was investigated to manufacture in one single step, a powder of individually coated particles containing atenolol (ATE), lovastatin (LOV) and acetylsalicylic acid (ASA)...Two different model APIs, namely paracetamol (well soluble) and fenofibrate (poorly soluble) were tested as well, revealing similar discrepancy in the coating performance. The coating layer formed during CES is most likely less dense as compared to the layer produced with tablet coating and consequently, more permeable for highly soluble APIs, but not for the poorly soluble compounds.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Journal:  Stomach Gastrin is Regulated by Sodium via PPAR-α and Dopamine D1 Receptor. (Pubmed Central) -  Jan 6, 2021   
    G cells in the stomach may be the sodium sensor that stimulates gastrin secretion, which enables the kidney to eliminate, acutely, an oral sodium load. Dopamine, via the D1R, by interacting with PPAR-α, is involved in this process.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Journal:  A Fenofibrate Diet Prevents Paclitaxel-Induced Peripheral Neuropathy in Mice. (Pubmed Central) -  Jan 2, 2021   
    Further work is required to elucidate the frequency of such autoimmune phenomenon in the transplant population. Taken together, our results show the therapeutic potential of fenofibrate in the prevention of PIPN development.
  • ||||||||||  Seebri Breezhaler (glycopyrronium bromide) / Novartis, Vectura, Sosei
    Journal:  Drugs for COPD. (Pubmed Central) -  Dec 30, 2020   
    Taken together, our results show the therapeutic potential of fenofibrate in the prevention of PIPN development. No abstract available
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Clinical, Journal:  The effect of premixed insulin to blood glucose concentration in patients with type 2 diabetes mellitus. (Pubmed Central) -  Dec 20, 2020   
    Drug interactions may occur in patients who use premixed insulin with glimepiride, lisinopril, fenofibrate, candesartan, irbesartan, and gemfibrozil. Conclusions In this study, premixed insulin have not reached the target of fasting and postprandial blood glucose concentrations in most patients.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Preclinical, Journal:  Quantifying In Vivo Luminal Drug Solubilization -Supersaturation-Precipitation Profiles to Explain the Performance of Lipid Based Formulations. (Pubmed Central) -  Dec 20, 2020   
    Conclusions In this study, premixed insulin have not reached the target of fasting and postprandial blood glucose concentrations in most patients. The data provide one of the first studies of in vivo luminal drug concentration, supersaturation and absorption from lipid based formulations and suggests that for FFB, whilst very high supersaturation may drive in vitro and in vivo precipitation, re-dissolution and drug absorption is rapid and efficient.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Journal:  PPARα activation directly upregulates thrombomodulin in the diabetic retina. (Pubmed Central) -  Dec 18, 2020   
    Furthermore, pemafibrate treatment inhibited diabetes-induced vascular leukostasis and leakage through the upregulation of THBD. Our results indicate that PPARα activation inhibits inflammatory and vasopermeable responses in the diabetic retina through the upregulation of TM.
  • ||||||||||  Asmasal Clickhaler (salbutamol dry-powder inhalation) / Recipharm, Vectura
    Thanks @AsmaSalek !! (Twitter) -  Dec 17, 2020   
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Preclinical, Journal:  A Study on the Role and Mechanism of Fenofibrate in Mice Renal Fibrosis Induced by Unilateral Ureteral Obstruction (Pubmed Central) -  Dec 16, 2020   
    Immunohistochemical staining results showed that, compared with UUO group, the expression levels of α-SMA, COL Ⅰin kidney tissues of UUO+Feno group were significantly reduced; Western blot and RT-PCR results showed that compared with the UUO group, the mRNA and protein expression levels of fibrotic factors were significantly reduced in the UUO+Feno group (P<0.05). Fenofibrate reduced mice renal fibrosis caused by unilateral ureteral obstruction and its mechanism may be relate to its regulation effect on the expressions of renal tissue fibrosis related genes.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Journal:  Fenofibrate prevents iron induced activation of canonical Wnt/β-catenin and oxidative stress signaling in the retina. (Pubmed Central) -  Dec 12, 2020   
    In addition, treatment of RPE cells with peroxisome proliferator-activated receptor (PPAR) α-agonist fenofibrate prevented iron-induced activation of oxidative stress and Wnt/β-catenin signaling by chelating the iron. The role of fenofibrate, an FDA-approved drug for hyperlipidemia, as an iron chelator has potentially significant therapeutic impact on iron associated degenerative diseases.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi
    Biomarker, Clinical, Journal:  Differential Epigenetic Factors in the Prediction of Cardiovascular Risk in Diabetic Patients. (Pubmed Central) -  Dec 3, 2020   
    Moreover, machine learning tools combined with tomography are advancing the individualized assessment of CV risk in these patients. We remark the need of combining epigenetics and advanced bioinformatic platforms to improve the prediction of vascular lesions in diabetics increasing the opportunity for CV precision medicine.
  • ||||||||||  Triglide (fenofibrate) / Vectura, Shionogi, Jakafi oral (ruxolitinib) / Novartis, Incyte
    [VIRTUAL] SEVERE HYPERTRIGLYCHERIDEMIA IN A PATIENT WITH GRAFT DISEASE AGAINST HOST IN TREATMENT WITH RUXOLITINIBE, SIROLIMUS AND CORTICOIDE () -  Nov 26, 2020 - Abstract #HEMO2020HEMO_485;    
    Cyclosporine was suspended due to renal failure and later replaced by Sirolimus...On 06/27, Sirolimus and Ruxolitinib were suspended and Ezetimibe, Fenofibrate and Atorvastatin started...In cases of moderate to severe hypertriglyceridemia, the use of omega-3 and fibrates may be considered, as well as second-line treatments include niacin, Ezetimibe or Colesevelam...The interactions between immunosuppressive medications and lipid-lowering drugs used to treat side effects from previous treatment need to be regularly monitored, as changes are clinically important. In case of association of corticosteroids Sirolimus and Ruxolitinib, strict control of the lipid profile must be implemented in view of the cases described.
  • ||||||||||  Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis, Trelegy Ellipta (fluticasone furoate/umeclidinium bromide/vilanterol) / GSK, Innoviva
    [VIRTUAL] TRIPLE THERAPY (ICS/LABA/LAMA) IN PATIENTS WITH UNCONTROLLED ASTHMA: A SYSTEMATIC REVIEW AND META-ANALYSIS () -  Nov 21, 2020 - Abstract #ACAAI2020ACAAI_561;    
    FEV1 in the triple therapy group was also increased compared to the ICS/LABA therapy (FEV1 80mL, 95% CI 50 to 100, I2=48%. p-value <0.00001, high certainty).Conclusions These findings support LAMA add-on therapy in patients with uncontrolled, persistent asthma despite treatment with ICS/LABA.