Zhejiang Hisun 
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  • ||||||||||  AD-35 / Zhejiang Hisun
    Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date:  ROAD: Efficacy and Safety of AD-35 in Treatment of Subjects With Mild to Moderate Alzheimer's Disease (clinicaltrials.gov) -  Mar 25, 2020   
    P2a,  N=55, Active, not recruiting, 
    Recruiting --> Active, not recruiting | N=88 --> 55 | Trial completion date: Jul 2020 --> Dec 2020 | Trial primary completion date: Jul 2019 --> Dec 2020
  • ||||||||||  Seebri Breezhaler (glycopyrronium bromide) / Novartis, Vectura, Sosei
    Possible Low-Value Medication Use by Persons with Idiopathic Pulmonary Fibrosis (PENNSYLVANIA CONVENTION CENTER, Hall D-E (200 Level), Area K) -  Mar 15, 2020 - Abstract #ATS2020ATS_9137;    
    One hundred seventeen (117, 28%) persons were first treated with a proton pump inhibitor following IPF diagnosis. Two hundred eleven (211, 50%) persons used a SABA.
  • ||||||||||  Bevespi Aerosphere (formoterol/glycopyrrolate) / AstraZeneca, Seebri Breezhaler (glycopyrronium bromide) / Novartis, Vectura, Sosei
    Review, Journal:  Glycopyrronium/Formoterol: A Review in COPD. (Pubmed Central) -  Jan 30, 2020   
    Glycopyrronium/formoterol was generally well tolerated in patients with moderate to very severe COPD, with most adverse events (AEs) being of mild or moderate severity. Thus, glycopyrronium/formoterol pMDI formulated using co-suspension delivery technology is a useful new addition that extends treatment options for patients with COPD.
  • ||||||||||  Seebri Breezhaler (glycopyrronium bromide) / Novartis, Vectura, Sosei
    Journal:  HPTLC Method for Determination of R, R-Glycopyrronium Bromide and its Related Impurities. (Pubmed Central) -  Jan 27, 2020   
    The method was used to investigate impurity profile of GLY in drug substance and drug product and could be applied in routine analysis of the drug. Comparison between the developed method and the reported method revealed no statistical difference.
  • ||||||||||  Seebri (glycopyrronium bromide) / Novartis, Vectura, Sosei
    Effect of high extrafine strength (HS) ICS-containing triple therapy on exacerbations in patients with severe asthma and persistent airflow limitation: Post-hoc analysis of the TRIGGER study (6F) -  Aug 26, 2019 - Abstract #ERS2019ERS_5632;    
    INTRODUCTION: Persistent airflow limitation (PAL) may predict a positive clinical response to add-on long-acting muscarinic antagonist (LAMA) in asthmatics on inhaled corticosteroids and long-acting β2-receptor agonists (ICS/LABA) OBJECTIVES: We evaluated the effect of extrafine HS beclometasone dipropionate/formoterol fumarate/glycopyrronium bromide (BDP/FF/GB) on asthma exacerbations in a subset of patients with PAL TRIGGER was a phase III randomized, parallel group trial comparing 52-week treatment with BDP/FF/GB 800/24/50 µg/d to BDP/FF 800/24 µg/d via pressurized metered dose inhalers (pMDI) and open-label treatment consisting of BDP/FF plus tiotropium Respimat® 5 μg/d (TioR) in adult patients with uncontrolled asthma on high-dose ICS/LABA and a history of exacerbation in the past year... PAL is associated with a greater response to triple therapy with extrafine HS BDP/FF/GB in patients with asthma uncontrolled on high dose ICS/LABA
  • ||||||||||  glycopyrrolate/indacaterol/mometasone (QVM149) / Novartis, Trelegy Ellipta (fluticasone furoate/umeclidinium bromide/vilanterol) / GSK, Innoviva, Seebri (glycopyrronium bromide) / Novartis, Vectura, Sosei
    Mechanisms leading to the bronchorelaxant synergy of ICS/LABA/LAMA combination (6C) -  Aug 26, 2019 - Abstract #ERS2019ERS_4111;    
    Methods Human isolated airways undergoing ex vivo asthma and COPD models were treated overnight with the intracellular glucocorticoid receptors antagonist RU486 (1 μM) to assess the role of the genomic mechanisms activated by BDP...Conclusion The synergy elicited by triple ICS/LABA/LAMA combination was related with the genomic effect of intracellular glucocorticoid receptors and the activation of Gsα subunit G-protein of β2-adrenoceptor, at least in human models of asthma and COPD. Funding This study was supported by Chiesi Farmaceutici, Italy.
  • ||||||||||  Seebri (glycopyrronium bromide) / Novartis, Vectura, Sosei
    Beclomethasone, formoterol and glycopyrronium: synergism of triple therapy on human airways (RETIRO) -  Aug 26, 2019 - Abstract #ERS2019ERS_2163;    
    Methods Human isolated bronchi were stimulated by histamine or carbachol and treated with BDP, FF and GP, administered alone and in combination at the concentration-ratio of the available fixed-dose combination (FDC; BDP/FF/GB 100:6:12.5)...Conclusion BDP/FF/GB FDC synergistically relaxed human isolated bronchi in ex vivo models of asthma and COPD. Funding This study was supported by Chiesi Farmaceutici, Italy.
  • ||||||||||  Seebri (glycopyrronium bromide) / Novartis, Vectura, Sosei
    Journal:  Multiple analytical methods for determination of formoterol and glycopyrronium simultaneously in their novel combined metered dose inhaler. (Pubmed Central) -  Aug 7, 2019   
    ...Recently approved combined inhaler of formoterol fumarate (FF) and glycopyrronium bromide (GLY) has been used in very low concentrations (µg level/actuation) doses in COPD patients...The percent recoveries of the inhaled drugs in their MDI were good. The method was successfully established for the quantitative analysis of FF and GLY in their combined pharmaceutical inhaler capsules to validate the therapeutic efficiency of the combined drugs in quality control labs.
  • ||||||||||  pritumumab (CLNH 11) / Nascent Biotech
    Preclinical, Journal:  A Binding Potency Assay for Pritumumab and Ecto-Domain Vimentin. (Pubmed Central) -  Jun 15, 2019   
    The enzyme linked immunosorbent assay (ELISA) to detect antibody-binding antigen can serve as a potency assay for release of manufactured samples to be used in clinical studies. Several layers of controls for this assay along with suitability testing for reagents and components of the assay must be developed before the assay can be incorporated for stability testing and release of manufatured samples.
  • ||||||||||  Seebri Breezhaler (glycopyrronium bromide) / Novartis, Vectura, Sosei
    Trial completion, Trial completion date, Trial initiation date, Trial primary completion date:  Bronchodilator Effects and Safety of Glycopyrronium Bromide (25 ug and 50 ug o.d.) in Asthma (clinicaltrials.gov) -  Feb 15, 2018   
    P2/3,  N=148, Completed, 
    Enrolling by invitation --> Recruiting Not yet recruiting --> Completed | Trial primary completion date: Apr 2018 --> Dec 2017 | Trial completion date: Apr 2018 --> Dec 2017 | Initiation date: May 2017 --> May 2017
  • ||||||||||  pritumumab (CLNH 11) / Nascent Biotech
    Journal:  Sabotaging of the oxidative stress response by an oncogenic noncoding RNA. (Pubmed Central) -  Sep 3, 2017   
    A major transcriptional regulator of the cellular antioxidant response, nuclear factor (erythroid-derived 2)-like 2 (NRF2), shuttled to the nucleus, as expected, in response to ACA11-driven increases in ROS; however, transcriptional up-regulation of some of NRF2's antioxidant target genes was abrogated in the presence of ACA11 overexpression. These data show for the first time that ACA11 promotes proliferation through inhibition of NRF2 function resulting in sustained ROS levels driving cancer cell proliferation.-Mahajan, N., Wu, H.-J., Bennett, R. L., Troche, C., Licht, J. D., Weber, J. D., Maggi, L. B., Jr., Tomasson, M. H. Sabotaging of the oxidative stress response by an oncogenic noncoding RNA.
  • ||||||||||  Seebri Breezhaler (glycopyrronium bromide) / Novartis, Vectura, Sosei
    Trial completion:  A Study of the Efficacy and Safety of NVA237 in Patients With Moderate to Severe COPD (clinicaltrials.gov) -  Mar 30, 2017   
    P4,  N=776, Completed, 
    Our findings suggest that genetic variation in kidney structure-related genes may contribute to T2D-attributed ESKD in the AA population. Recruiting --> Completed
  • ||||||||||  Seebri Breezhaler (glycopyrronium bromide) / Novartis, Vectura, Sosei
    Enrollment open, Trial primary completion date:  A Study of the Efficacy and Safety of NVA237 in Patients With Moderate to Severe COPD (clinicaltrials.gov) -  Apr 8, 2016   
    P4,  N=752, Recruiting, 
    Recruiting --> Completed Not yet recruiting --> Recruiting | Trial primary completion date: Apr 2017 --> Dec 2016