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  • ||||||||||  Cervarix (recombinant human papillomavirus bivalent vaccine) / GSK, Japan Vaccine, Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) / UniQuest
    Review, Journal:  Human papillomavirus infection: Epidemiology, biology, host interactions, cancer development, prevention, and therapeutics. (Pubmed Central) -  Apr 26, 2024   
    Education and awareness about HPV and its prevention are crucial in promoting optimal sexual health. This study aimed to carry out a literature review considering several aspects involving HPV infection: Global distribution, prevalence, biology, host interactions, cancer development, prevention, therapeutics, coinfection with other viruses, coinfection with bacteria, association with head and neck squamous cell carcinomas, and association with anal cancer.
  • ||||||||||  Blenrep (belantamab mafodotin-blmf) / GSK
    Enrollment closed:  A phase I/II single arm study of combination Belantamab Mafodotin, Carfilzomib, Dexamethasone in patients with early relapsed multiple myeloma (EUDRACT) -  Apr 26, 2024   
    P1/2,  N=68, Active, not recruiting, 
    This study aimed to carry out a literature review considering several aspects involving HPV infection: Global distribution, prevalence, biology, host interactions, cancer development, prevention, therapeutics, coinfection with other viruses, coinfection with bacteria, association with head and neck squamous cell carcinomas, and association with anal cancer. Recruiting --> Active, not recruiting
  • ||||||||||  Dysport (abobotulinumtoxinA) / Ipsen, Xeomin (incobotulinumtoxinA) / Merz Pharma, Botox (onabotulinumtoxin A) / GSK, AbbVie, Healis Therap
    New trial:  Strategy to Adapt Botulinum Toxin Doses in Dystonia (clinicaltrials.gov) -  Apr 25, 2024   
    P=N/A,  N=100, Not yet recruiting, 
  • ||||||||||  Prolia (denosumab) / Amgen
    Trial termination, Metastases:  SPLENDOUR: Survival imProvement in Lung cancEr iNduced by DenOsUmab theRapy (clinicaltrials.gov) -  Apr 25, 2024   
    P3,  N=595, Terminated, 
    Completed --> Terminated; Completion of recruitment was not feasible as accrual was slower than anticipated. Even if a benefit for denosumab could be shown, these results would be of very limited clinical impact by the time they would be available
  • ||||||||||  R21/Matrix-M / University of Oxford, Serum Institute of India, Mosquirix (RTS,S) / GSK
    Review, Journal:  Current Status of Malaria Control and Elimination in Africa: Epidemiology, Diagnosis, Treatment, Progress and Challenges. (Pubmed Central) -  Apr 24, 2024   
    China's experience in eliminating malaria is conducive to Africa's malaria prevention and control, and China-Africa cooperation needs to be constantly deepened and advanced. Our review aims to help the global public develop a comprehensive understanding of malaria in Africa, thereby contributing to malaria control and elimination.
  • ||||||||||  alpibectir (BVL-GSK098) / BioVersys, GSK
    P1 data, Journal:  First-in-human study of alpibectir (BVL-GSK098), a novel potent anti-TB drug. (Pubmed Central) -  Apr 24, 2024   
    P1
    Alpibectir was generally well tolerated, and no clinically relevant safety findings were identified in the participants treated during SAD or MAD. The PK is dose-proportional and affected by food.
  • ||||||||||  Mosquirix (RTS,S) / GSK
    Review, Journal:  Vaccines and monoclonal antibodies: new tools for malaria control. (Pubmed Central) -  Apr 24, 2024   
    This review summarizes the development of the anti-PfCSP vaccines and mAbs, and recent topics in the blood- and transmission-blocking-stage vaccine candidates and mAbs. We further discuss issues of the current vaccines and the directions for the development of next-generation vaccines.
  • ||||||||||  Prolia (denosumab) / Amgen, Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
    Clinical, Retrospective data, Journal:  The sequential antifracturative treatment: a meta-analysis of randomized clinical trials. (Pubmed Central) -  Apr 24, 2024   
    In general, at 2?years after the switch from anabolic to antiresorptive drugs, a weighted BMD was increased at the lumbar spine, total hip, and femoral neck site. The Task Force formulated recommendations on sequential therapy, which is the first treatment with anabolic drugs or 'bone builders' in patients with very high or imminent risk of fracture.
  • ||||||||||  Brexafemme (ibrexafungerp) / SCYNEXIS, GSK
    Journal:  Biosynthesis of Enfumafungin-type Antibiotic Reveals an Unusual Enzymatic Fusion Pattern and Unprecedented C-C Bond Cleavage. (Pubmed Central) -  Apr 24, 2024   
    These compounds exhibit significant antifungal properties with ibrexafungerp, a semisynthetic derivative of enfumafungin, recently gaining FDA's approval as the first oral antifungal drug for treating invasive vulvar candidiasis...FsoE is a P450 enzyme that catalyzes successive oxidation reactions at C19 to facilitate a C-C bond cleavage, producing an oxidized carboxyl group and a reduced methyl group that have never been observed in known P450 enzymes. Our study thus sets the important foundation for the manufacture of enfumafungin-type antibiotics using biosynthetic approaches.
  • ||||||||||  Journal:  Biological treatments in childhood asthma. (Pubmed Central) -  Apr 24, 2024   
    However, the choice of the most appropriate biologics remains a pending issue. On the other hand, to the extent that several of the biologics have been available for a relatively short time, the most robust evidence in terms of efficacy and safety in children is that of omalizumab.
  • ||||||||||  Journal:  Precision care in the treatment of pediatric asthma. (Pubmed Central) -  Apr 24, 2024   
    On the other hand, to the extent that several of the biologics have been available for a relatively short time, the most robust evidence in terms of efficacy and safety in children is that of omalizumab. An understanding of underlying immunologic and genetic mechanisms affecting the development of asthma in pediatric patients has resulted in the production of numerous targeted therapies that have led to improvement in lung function and reduced exacerbation burden.
  • ||||||||||  Livtencity (maribavir) / Takeda, GSK
    PK/PD data, Journal:  Physiologically-based pharmacokinetic modeling for maribavir to inform dosing in drug-drug interaction scenarios with cyp3a4 Inducers and Inhibitors. (Pubmed Central) -  Apr 24, 2024   
    Based on the results from the clinical DDI study, coadministration of maribavir with rifampin is not recommended. The PBPK model did not predict a clinically significant effect of CYP3A4 inhibitors on maribavir exposure; however, it predicted that strong or moderate CYP3A4 inducers, including phenytoin, phenobarbital, carbamazepine, and efavirenz, may reduce maribavir exposure to a clinically significant extent, and may prompt consideration of maribavir dosing increase according to the local approved labels and/or regulations.
  • ||||||||||  Benlysta (belimumab) / GSK
    New P2 trial:  BELief: Belimumab in Autoimmune Hepatitis (clinicaltrials.gov) -  Apr 24, 2024   
    P2,  N=48, Not yet recruiting, 
  • ||||||||||  Ojjaara (momelotinib) / GSK
    Journal:  Clinical assessment of momelotinib drug-drug interactions via CYP3A metabolism and transporters. (Pubmed Central) -  Apr 22, 2024   
    Momelotinib DDI perpetrator potential (multiple-dose) was evaluated with CYP3A4 and breast cancer resistance protein (BCRP) substrates (midazolam and rosuvastatin, respectively)...Safety findings were mild in this short-term study in healthy volunteers. This analysis suggests that momelotinib interactions with OATP1B1/1B3 inhibitors and BCRP substrates may warrant monitoring for adverse reactions or dose adjustments.
  • ||||||||||  Emgality (galcanezumab-gnlm) / Eli Lilly, Daiichi Sankyo, Organon, Ajovy (fremanezumab-vfrm) / Teva, Botox (onabotulinumtoxin A) / GSK, AbbVie, Healis Therap
    Review, Journal, Adverse events, Serious adverse event:  Adverse and serious adverse events incidence of pharmacological interventions for managing chronic and episodic migraine in adults: a systematic review. (Pubmed Central) -  Apr 22, 2024   
    All drugs showed a certain incidence of infections and infestations, with Onabotulinumtoxin A (BTA) having the lowest rate...Calcitonin gene-related peptide (CGRP) monoclonal antibodies (MAbs) such as fremanezumab and galcanezumab were linked to more general disorders and administration site conditions than other drugs...We suggest conducting head-to-head RCTs to evaluate the safety profile of oral medications, BTA, and CGRP MAbs in episodic and/or chronic migraine populations. CRD42021265993.
  • ||||||||||  Victoza (liraglutide) / Novo Nordisk, Qsymia (topiramate/phentermine) / IEH Biopharma, Alvogen, Xenical (orlistat) / Roche, GSK
    Journal, Surgery, Bariatric surgery:  Utilization of Anti-obesity Medications After Bariatric Surgery: Analysis of a Large National Database. (Pubmed Central) -  Apr 22, 2024   
    Despite a relatively high incidence of weight regain, AOMs are underutilized following bariatric surgery. It is imperative that barriers to their use be addressed and that AOMs be considered earlier and more frequently in patients with insufficient weight loss or weight regain after bariatric surgery.
  • ||||||||||  Prolia (denosumab) / Amgen
    Journal:  Bone loss after discontinuation of denosumab: the devil is in the details. (Pubmed Central) -  Apr 21, 2024   
    Bone turnover markers were appropriately suppressed and bone mineral density increased in the spine and hip. This case illustrates how the overshooting phenomenon following denosumab discontinuation may be compounded by the development of secondary conditions, which can result in suboptimal response to antiresorptive osteoporosis medications.
  • ||||||||||  Benlysta (belimumab) / GSK, Lupkynis (voclosporin) / Aurinia Pharma, Saphnelo (anifrolumab) / AstraZeneca
    Review, Journal:  Systemic lupus erythematosus. (Pubmed Central) -  Apr 20, 2024   
    In the last decade, there have been a few major breakthroughs in approved treatments for SLE and lupus nephritis, such as belimumab, anifrolumab, and voclosporin...Comorbidities due to both disease activity and treatment adverse effects, especially infections, osteoporosis, and cardiovascular disease, necessitate vigilant prevention and management strategies. Tailoring treatment options to achieve remission, while balancing treatment-related comorbidities, are priority areas of SLE management.
  • ||||||||||  Benlysta (belimumab) / GSK, Yinuokai (orelabrutinib) / InnoCare, Biogen, enpatoran (M5049) / EMD Serono
    Efficacy evaluation of B cell targeting drugs and the involved mechanism of action study in humanized BAFF transgenic SLE mice model (Exhibit Hall F1; Poster Board Number: B902) -  Apr 20, 2024 - Abstract #IMMUNOLOGY2024IMMUNOLOGY_2505;    
    Only the BTK inhibitor Orelabrutinib significantly eliminated serum Igs levels. Enpatoran exhibited a similar ability to Orelabrutinib in reducing T follicular helper cell and plasma cell populations spleen and lymph nodes.In summary, the humanized BAFF transgenic SLE model proves to be a valuable tool for preclinical efficacy studies in SLE treatment and understanding pathogenesis.
  • ||||||||||  MenQuadfi (meningococcal A C Y and W polysaccharide tetanus toxoid conjugate vaccine) / Sanofi, Menveo (meningococcal-groups A, C, W-135 and Y oligosaccharide CRM197 conjugate vaccine) / GSK, Typhim Vi (typhoid polysaccharide vaccine) / Sanofi
    Journal, IO biomarker:  Monophosphoryl Lipid A-based Adjuvant to Promote the Immunogenicity of Multivalent Meningococcal Polysaccharide Conjugate Vaccines. (Pubmed Central) -  Apr 20, 2024   
    Many Gram-negative bacterial polysaccharide vaccines, including the tetravalent meningococcal conjugate vaccines (MCV4) and typhoid Vi polysaccharide vaccines, do not incorporate adjuvants...Consistent with this hypothesis, two Food and Drug Administration-approved MCV4 vaccines, MENVEO and MenQuadfi, lack TLR4 ligands...Turbo upregulated the expression of the costimulatory molecules CD40 and CD86 on B cells, and Turbo-driven adjuvanticity is lost in mice deficient in CD40 and CD86. These data suggest that Turbo induces the required costimulatory molecules for its adjuvant activity and that incorporation of Turbo could make bacterial polysaccharide vaccines more immunogenic, minimize booster requirements, and be cost-effective, particularly for those individuals in low- and middle-income and disease-endemic countries.
  • ||||||||||  Prolia (denosumab) / Amgen
    Journal:  Denosumab-induced bone changes in a child: a case report. (Pubmed Central) -  Apr 20, 2024   
    These data suggest that Turbo induces the required costimulatory molecules for its adjuvant activity and that incorporation of Turbo could make bacterial polysaccharide vaccines more immunogenic, minimize booster requirements, and be cost-effective, particularly for those individuals in low- and middle-income and disease-endemic countries. We present the case of a 9-year-old girl who developed striking bone changes following two years of denosumab therapy for giant cell lesions of the jaw.
  • ||||||||||  Nutlin-3 / EMD Serono, Zejula (niraparib) / GSK, J&J
    Journal, PARP Biomarker:  CLDN18: Clinical, Pathological, and Genetic Signatures with Drug Screening in Gastric Adenocarcinoma. (Pubmed Central) -  Apr 19, 2024   
    Our study provides a comprehensive understanding of the biological role of CLDN18-based bioinformatics and machine learning analysis in STAD, shedding light on its prognostic significance and potential therapeutic implications. To fully elucidate the molecular intricacies of CLDN18, further investigation is warranted, particularly through in vitro and in vivo studies.
  • ||||||||||  Botox (onabotulinumtoxin A) / GSK, AbbVie, Healis Therap
    Journal:  Dermatology by Dermatologists. (Pubmed Central) -  Apr 19, 2024   
    To fully elucidate the molecular intricacies of CLDN18, further investigation is warranted, particularly through in vitro and in vivo studies. No abstract available