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  • ||||||||||  Goofice (elobixibat) / Ipsen
    Phase classification:  Study of A3309 in Patients With Dyslipidemia (clinicaltrials.gov) -  Mar 7, 2024   
    P2,  N=36, Completed, 
    Phase classification: P2a --> P2
  • ||||||||||  Imaavy (nipocalimab-aahu) / J&J
    Trial initiation date:  DAISY: A Study to Evaluate the Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis (clinicaltrials.gov) -  Mar 2, 2024   
    P2,  N=85, Recruiting, 
    Furthermore, the observed suboptimal oocyte yield after agonist ovulation triggering in low responders in the dual uninterrupted OS group is a reason for concern and further scrutiny, given that previous RCTs have shown similar outcomes in normal and high responders after hCG and GnRH agonist triggers. Initiation date: Aug 2023 --> Feb 2023
  • ||||||||||  Vowst (fecal microbiota spores, live-brpk) / Seres Therap, Rebyota (fecal microbiota, live-jslm) / Ferring
    Clinical guideline:  AGA Clinical Practice Guideline on Fecal Microbiota-Based Therapies for Select Gastrointestinal Diseases. (Pubmed Central) -  Feb 28, 2024   
    Conventional fecal microbiota transplant is an adjuvant treatment for select adults hospitalized with severe or fulminant C difficile infection not responding to standard of care antibiotics. Fecal microbiota transplant cannot yet be recommended in other gastrointestinal conditions.
  • ||||||||||  Nubeqa (darolutamide) / Bayer, Orion Corp, Verzenio (abemaciclib) / Eli Lilly
    Enrollment closed:  Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer (clinicaltrials.gov) -  Feb 28, 2024   
    P1/2,  N=93, Active, not recruiting, 
    The results suggest the potential effect of RF on binding the fragment crystallisable portion of certain TNFi. Recruiting --> Active, not recruiting
  • ||||||||||  Adstiladrin (nadofaragene firadenovec-vncg) / Ferring, Keytruda (pembrolizumab) / Merck (MSD)
    Review, Journal:  BCG and Alternative Therapies to BCG Therapy for Non-Muscle-Invasive Bladder Cancer. (Pubmed Central) -  Feb 27, 2024   
    Moreover, recent logistic issues with BCG production caused a worldwide BCG shortage, re-sparking interest in alternative BCG treatments including mitomycin C, sequential gemcitabine with docetaxel, and others. This review encompasses both the historic and current role of BCG in the treatment of non-muscle-invasive bladder cancer, revisiting BCG alternative therapies and reviewing the novel therapeutics that were approved for the BCG-unresponsive stage or are under active investigation.
  • ||||||||||  Cimzia (certolizumab pegol) / Astellas, UCB
    Journal:  Characterization of anti-drug antibody dynamics using a bivariate mixed hidden-markov model by nonlinear-mixed effects approach. (Pubmed Central) -  Feb 26, 2024   
    A mixed hidden-Markov model (MHMM) was developed to characterize the underlying (hidden) formation of ADA against the biologic, using certolizumab pegol (CZP), as a test drug...Individual state sequences obtained using a Viterbi algorithm suggested that the model was able to determine the start of ADA production for each individual, being a more assay-independent methodology than traditional population PK. The model serves as a basis for identification of covariates influencing the ADA formation, and thus has the potential to identify aspects that minimize its impact on PK and/or efficacy.
  • ||||||||||  Review, Journal:  Integrating Nanotechnological Advancements of Disease-Modifying Anti-Rheumatic Drugs into Rheumatoid Arthritis Management. (Pubmed Central) -  Feb 24, 2024   
    Biologic DMARDs (bDMARDs) like infliximab, rituximab, etanercept, adalimumab, tocilizumab, certolizumab pegol, and abatacept have greater effectiveness with fewer adverse effects in comparison to non-biologic DMARDs...The main focus of this review article is to highlight the potential role of nanotechnology in the drug delivery of DMARDs for increasing solubility, dissolution, and bioavailability for the improved management of RA. This article also focusses on the different aspects of nanoparticles like their applications in biologics, biocompatibility, body clearance, scalability, drug loading, and stability issues.
  • ||||||||||  Glypressin (terlipressin) / Ferring
    Trial completion date, Trial primary completion date:  Continuous Versus Bolus Infusion of Terlipressin for Portal Hypertension Related Bleeding in Liver Cirrhosis (clinicaltrials.gov) -  Feb 22, 2024   
    P=N/A,  N=40, Not yet recruiting, 
    This article also focusses on the different aspects of nanoparticles like their applications in biologics, biocompatibility, body clearance, scalability, drug loading, and stability issues. Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025
  • ||||||||||  Cimzia (certolizumab pegol) / Astellas, UCB
    Unpredictable Onset of Active Tuberculosis in a Patient on TNF Inhibitors: A Case of Delayed Onset Tuberculous Pleural Effusion Following Latent Tuberculosis Treatment (San Diego Convention Center, Area I (Hall H, Ground Level)) -  Feb 20, 2024 - Abstract #ATS2024ATS_1928;    
    Six days prior to admission, she developed shortness of breath, fatigue, and low-grade fever, and was treated with cephalexin...We are reporting a case of treated latent tuberculosis with active tuberculous pleural effusion amidst continued TNF inhibitor treatment. Establishing a global registry to investigate tuberculosis risk stratification tools and the development of evidence-based monitoring strategies for patients receiving TNF inhibitors is imperative for early diagnosis and expeditious treatment.
  • ||||||||||  Adstiladrin (nadofaragene firadenovec-vncg) / Ferring
    Trial completion date, Trial primary completion date, Real-world evidence, Real-world:  ABLE-41: ADSTILADRIN Early Utilization and Outcomes in the Real World Setting (clinicaltrials.gov) -  Feb 15, 2024   
    P=N/A,  N=800, Recruiting, 
    Active, not recruiting --> Completed | N=390 --> 772 Trial completion date: Dec 2026 --> Dec 2025 | Trial primary completion date: Dec 2026 --> Dec 2025
  • ||||||||||  Rekovelle (follitropin delta) / Ferring
    Trial completion date, Trial primary completion date:  LadyDe: Luteal Phase Ovarian Stimulation With Follitropin Delta and Dydrogesterone (clinicaltrials.gov) -  Feb 15, 2024   
    P=N/A,  N=50, Recruiting, 
    Trial completion date: Dec 2026 --> Dec 2025 | Trial primary completion date: Dec 2026 --> Dec 2025 Trial completion date: May 2024 --> Dec 2024 | Trial primary completion date: Sep 2023 --> Sep 2024
  • ||||||||||  Phase classification, Trial completion date, Trial primary completion date:  First Strike, Second Strike Therapies for High Risk Metastatic Castration Sensitive Prostate Cancer (clinicaltrials.gov) -  Feb 15, 2024   
    P2,  N=31, Recruiting, 
    Trial completion date: Sep 2022 --> Dec 2025 | Trial primary completion date: Dec 2021 --> Aug 2025 Phase classification: P2a --> P2 | Trial completion date: May 2026 --> Jan 2027 | Trial primary completion date: May 2025 --> Jan 2027
  • ||||||||||  olamkicept (FE999301) / Ferring
    Journal:  Nonspecific Inhibition of IL6 Family Cytokine Signalling by Soluble gp130. (Pubmed Central) -  Feb 14, 2024   
    These data show that sgp130Fc does not exclusively block IL6 trans-signalling and reveal instead that broad inhibition of gp130 signalling likely underlies its therapeutic effects. This proposes global or modular inhibition of gp130 as a therapeutic approach for treating human disease.
  • ||||||||||  Lutrelef (gonadorelin acetate) / Ferring
    Enrollment open:  Lutre-UP: GnRH Therapy on Cognition in Down Syndrome (clinicaltrials.gov) -  Feb 9, 2024   
    P2/3,  N=56, Recruiting, 
    Further studies are warranted to investigate the underlying mechanisms and identify patient-related susceptibility factors, thus supporting timely diagnosis and safe(r) prescribing of bDMARDs. Active, not recruiting --> Recruiting
  • ||||||||||  Taltz (ixekizumab) / Eli Lilly, Japan Tobacco, Humira (adalimumab) / AbbVie, Cimzia (certolizumab pegol) / Astellas, UCB
    Journal:  Complex decongestive therapy in hidradenitis suppurativa-related genital lymphoedema: a case report. (Pubmed Central) -  Feb 7, 2024   
    When the patient was assessed, ixekizumab treatment for his HS was planned...He achieved a better scrotal contour, the degree of the buried penis was decreased, and urination was easier and painless. The findings of this case report showed that CDT was an easily applicable, practical and promising method that offered a rapid treatment response for HS-related genital lymphoedema.
  • ||||||||||  NN1213 / Novo Nordisk, Cimzia (certolizumab pegol) / Astellas, UCB
    Trial completion, Trial completion date:  Lipids, Inflammation, and CV Risk in RA (clinicaltrials.gov) -  Feb 5, 2024   
    P=N/A,  N=76, Completed, 
    No abstract available Recruiting --> Completed | Trial completion date: Jul 2024 --> Aug 2023
  • ||||||||||  Rekovelle (follitropin delta) / Ferring
    Trial completion:  IRIS: Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Indian Women (clinicaltrials.gov) -  Feb 2, 2024   
    P3,  N=220, Completed, 
    This should be considered, particularly in patients at risk of having high progesterone levels at the end of the follicular phase when a fresh embryo transfer is planned. Active, not recruiting --> Completed
  • ||||||||||  Norprolac (quinagolide) / Ferring
    Journal:  Editorial: Insights in hyperprolactinemia. (Pubmed Central) -  Jan 30, 2024   
    Dinoprostone vaginal gel and oral misoprostol as a second cycle of induction appear to be both effective in achieving active labor and vaginal delivery after failure of dinoprostone vaginal insert, without a significant rate of adverse events. No abstract available
  • ||||||||||  Norprolac (quinagolide) / Ferring
    Journal:  Streamlined Stereoselective Entry to (-)-Quinagolide and to 3-Substituted Octahydrobenzo[g]-Quinolines. (Pubmed Central) -  Jan 28, 2024   
    The key steps involved are a copper-catalyzed regioselective arylation of (S)-epichlorohydrin with 1,6-dimethoxynaphthalene and a diastereoselective trans-reduction of a cyclic enamine intermediate. The possibility to use both enantiomers of epichlorohydrin and the diastereodivergency found in the reduction process paves the way for a general preparation also in the nonracemic form of chiral trans-fused 3-substituted octahydrobenzo[g]quinolines that are privileged structures in medicinal chemistry.
  • ||||||||||  Cimzia (certolizumab pegol) / Astellas, UCB
    Journal:  Successful subcutaneous desensitization to certolizumab. (Pubmed Central) -  Jan 26, 2024   
    The possibility to use both enantiomers of epichlorohydrin and the diastereodivergency found in the reduction process paves the way for a general preparation also in the nonracemic form of chiral trans-fused 3-substituted octahydrobenzo[g]quinolines that are privileged structures in medicinal chemistry. No abstract available