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National Antibiotic Consumption for Human Use in Sierra Leone (2017–2019): a Cross-Sectional Study
Tropical Medicine and Infectious Disease Article National Antibiotic Consumption for Human Use in Sierra Leone (2017–2019): A Cross-Sectional Study Joseph Sam Kanu 1,2,* , Mohammed Khogali 3, Katrina Hann 4 , Wenjing Tao 5, Shuwary Barlatt 6,7, James Komeh 6, Joy Johnson 6, Mohamed Sesay 6, Mohamed Alex Vandi 8, Hannock Tweya 9, Collins Timire 10, Onome Thomas Abiri 6,11 , Fawzi Thomas 6, Ahmed Sankoh-Hughes 12, Bailah Molleh 4, Anna Maruta 13 and Anthony D. Harries 10,14 1 National Disease Surveillance Programme, Sierra Leone National Public Health Emergency Operations Centre, Ministry of Health and Sanitation, Cockerill, Wilkinson Road, Freetown, Sierra Leone 2 Department of Community Health, Faculty of Clinical Sciences, College of Medicine and Allied Health Sciences, University of Sierra Leone, Freetown, Sierra Leone 3 Special Programme for Research and Training in Tropical Diseases (TDR), World Health Organization, 1211 Geneva, Switzerland; [email protected] 4 Sustainable Health Systems, Freetown, Sierra Leone; [email protected] (K.H.); [email protected] (B.M.) 5 Unit for Antibiotics and Infection Control, Public Health Agency of Sweden, Folkhalsomyndigheten, SE-171 82 Stockholm, Sweden; [email protected] 6 Pharmacy Board of Sierra Leone, Central Medical Stores, New England Ville, Freetown, Sierra Leone; [email protected] (S.B.); [email protected] (J.K.); [email protected] (J.J.); [email protected] (M.S.); [email protected] (O.T.A.); [email protected] (F.T.) Citation: Kanu, J.S.; Khogali, M.; 7 Department of Pharmaceutics and Clinical Pharmacy & Therapeutics, Faculty of Pharmaceutical Sciences, Hann, K.; Tao, W.; Barlatt, S.; Komeh, College of Medicine and Allied Health Sciences, University of Sierra Leone, Freetown 0000, Sierra Leone 8 J.; Johnson, J.; Sesay, M.; Vandi, M.A.; Directorate of Health Security & Emergencies, Ministry of Health and Sanitation, Sierra Leone National Tweya, H.; et al. -
WO 2018/223101 Al 06 December 2018 (06.12.2018) W !P O PCT
(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2018/223101 Al 06 December 2018 (06.12.2018) W !P O PCT (51) International Patent Classification: (71) Applicant: JUNO THERAPEUTICS, INC. [US/US]; 400 A 61K 35/1 7 (20 15.0 1) A 61P 35/00 (2006 .0 1) Dexter Ave. N., Suite 1200, Seattle, WA 98109 (US). (21) International Application Number: (72) Inventor: ALBERTSON, Tina; 400 Dexter Ave. N., Suite PCT/US2018/035755 1200, Seattle, WA 98109 (US). (22) International Filing Date: (74) Agent: AHN, Sejin et al; Morrison & Foerster LLP, 1253 1 0 1 June 2018 (01 .06.2018) High Bluff Drive, Suite 100, San Diego, CA 92130-2040 (US). (25) Filing Language: English (81) Designated States (unless otherwise indicated, for every (26) Publication Language: English kind of national protection available): AE, AG, AL, AM, (30) Priority Data: AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, 62/5 14,774 02 June 2017 (02.06.2017) US CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, 62/5 15,530 05 June 2017 (05.06.2017) US DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, 62/521,366 16 June 2017 (16.06.2017) u s HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, 62/527,000 29 June 2017 (29.06.2017) u s KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, 62/549,938 24 August 2017 (24.08.2017) u s MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, 62/580,425 0 1 November 2017 (01 .11.2017) u s OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, 62/593,871 0 1 December 2017 (01 .12.2017) u s SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, 62/596,764 08 December 2017 (08.12.2017) u s TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. -
Folic Acid Antagonists: Antimicrobial and Immunomodulating Mechanisms and Applications
International Journal of Molecular Sciences Review Folic Acid Antagonists: Antimicrobial and Immunomodulating Mechanisms and Applications Daniel Fernández-Villa 1, Maria Rosa Aguilar 1,2 and Luis Rojo 1,2,* 1 Instituto de Ciencia y Tecnología de Polímeros, Consejo Superior de Investigaciones Científicas, CSIC, 28006 Madrid, Spain; [email protected] (D.F.-V.); [email protected] (M.R.A.) 2 Consorcio Centro de Investigación Biomédica en Red de Bioingeniería, Biomateriales y Nanomedicina, 28029 Madrid, Spain * Correspondence: [email protected]; Tel.: +34-915-622-900 Received: 18 September 2019; Accepted: 7 October 2019; Published: 9 October 2019 Abstract: Bacterial, protozoan and other microbial infections share an accelerated metabolic rate. In order to ensure a proper functioning of cell replication and proteins and nucleic acids synthesis processes, folate metabolism rate is also increased in these cases. For this reason, folic acid antagonists have been used since their discovery to treat different kinds of microbial infections, taking advantage of this metabolic difference when compared with human cells. However, resistances to these compounds have emerged since then and only combined therapies are currently used in clinic. In addition, some of these compounds have been found to have an immunomodulatory behavior that allows clinicians using them as anti-inflammatory or immunosuppressive drugs. Therefore, the aim of this review is to provide an updated state-of-the-art on the use of antifolates as antibacterial and immunomodulating agents in the clinical setting, as well as to present their action mechanisms and currently investigated biomedical applications. Keywords: folic acid antagonists; antifolates; antibiotics; antibacterials; immunomodulation; sulfonamides; antimalarial 1. -
(CHMP) Agenda for the Meeting on 22-25 February 2021 Chair: Harald Enzmann – Vice-Chair: Bruno Sepodes
22 February 2021 EMA/CHMP/107904/2021 Human Medicines Division Committee for medicinal products for human use (CHMP) Agenda for the meeting on 22-25 February 2021 Chair: Harald Enzmann – Vice-Chair: Bruno Sepodes 22 February 2021, 09:00 – 19:30, room 1C 23 February 2021, 08:30 – 19:30, room 1C 24 February 2021, 08:30 – 19:30, room 1C 25 February 2021, 08:30 – 19:30, room 1C Disclaimers Some of the information contained in this agenda is considered commercially confidential or sensitive and therefore not disclosed. With regard to intended therapeutic indications or procedure scopes listed against products, it must be noted that these may not reflect the full wording proposed by applicants and may also vary during the course of the review. Additional details on some of these procedures will be published in the CHMP meeting highlights once the procedures are finalised and start of referrals will also be available. Of note, this agenda is a working document primarily designed for CHMP members and the work the Committee undertakes. Note on access to documents Some documents mentioned in the agenda cannot be released at present following a request for access to documents within the framework of Regulation (EC) No 1049/2001 as they are subject to on- going procedures for which a final decision has not yet been adopted. They will become public when adopted or considered public according to the principles stated in the Agency policy on access to documents (EMA/127362/2006). Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union © European Medicines Agency, 2021. -
Tanibirumab (CUI C3490677) Add to Cart
5/17/2018 NCI Metathesaurus Contains Exact Match Begins With Name Code Property Relationship Source ALL Advanced Search NCIm Version: 201706 Version 2.8 (using LexEVS 6.5) Home | NCIt Hierarchy | Sources | Help Suggest changes to this concept Tanibirumab (CUI C3490677) Add to Cart Table of Contents Terms & Properties Synonym Details Relationships By Source Terms & Properties Concept Unique Identifier (CUI): C3490677 NCI Thesaurus Code: C102877 (see NCI Thesaurus info) Semantic Type: Immunologic Factor Semantic Type: Amino Acid, Peptide, or Protein Semantic Type: Pharmacologic Substance NCIt Definition: A fully human monoclonal antibody targeting the vascular endothelial growth factor receptor 2 (VEGFR2), with potential antiangiogenic activity. Upon administration, tanibirumab specifically binds to VEGFR2, thereby preventing the binding of its ligand VEGF. This may result in the inhibition of tumor angiogenesis and a decrease in tumor nutrient supply. VEGFR2 is a pro-angiogenic growth factor receptor tyrosine kinase expressed by endothelial cells, while VEGF is overexpressed in many tumors and is correlated to tumor progression. PDQ Definition: A fully human monoclonal antibody targeting the vascular endothelial growth factor receptor 2 (VEGFR2), with potential antiangiogenic activity. Upon administration, tanibirumab specifically binds to VEGFR2, thereby preventing the binding of its ligand VEGF. This may result in the inhibition of tumor angiogenesis and a decrease in tumor nutrient supply. VEGFR2 is a pro-angiogenic growth factor receptor -
SGO-2020-Annual-Meet
Society of Gynecologic Oncology 2020 Annual Meeting on Women’s Cancer Abstracts for Oral Presentation Scientific Plenary I: Shaping the Future with Innovative Clinical Trials: A Clearer Vision Ahead in Gynecologic Cancer 1 - Scientific Plenary Sentinel lymph node biopsy versus lymphadenectomy for high-grade endometrial cancer staging (SENTOR trial): A prospective multicenter cohort study M.C. Cusimanoa, D. Vicusb, K. Pulmanc, M.Q. Bernardinid, S. Laframboised, T. Mayd, G. Bouchard-Fortierd, L. Hogend, L.T. Gienb, A.L. Covensb, R. Kupetse, B.A. Clarkea, M. Cesaric, M. Rouzbahmand, J. Mirkovicb, G. Turashvilid, M. Magantid, A. Ziad, G.E.V. Ened and S.E. Fergusond. aUniversity of Toronto, Toronto, ON, Canada, bSunnybrook Odette Cancer Centre, Toronto, ON, Canada, cTrillium Health Partners, Credit Valley Hospital/University of Toronto, Mississauga, ON, Canada, dPrincess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada, eSunnybrook Cancer Centre/University of Toronto, Toronto, ON, Canada Objective: It is unclear whether sentinel lymph node biopsy (SLNB) can replace complete lymphadenectomy in women with high-grade endometrial cancer (EC). We performed a prospective multicenter cohort study (the SENTOR trial) to evaluate the performance characteristics of SLNB using indocyanine green (ICG) in stage I high-grade EC (ClinicalTrials.gov ID: NCT01886066). Method: Patients with clinical stage I grade 2 endometrioid or high-grade EC (grade 3 endometrioid, serous, clear cell, carcinosarcoma, undifferentiated, or mixed tumors) undergoing laparoscopic or robotic surgery at 3 cancer centers in Toronto, Canada, were prospectively recruited for SLNB with ICG. After SLNB, high-grade EC patients underwent pelvic and paraaortic lymphadenectomy (PLND/PALND), and grade 2 endometrioid EC patients underwent PLND only. -
Eisai Submits Marketing Authorization Application in Japan
N o. 20-15 March 26, 2020 Eisai Co., Ltd. EISAI SUBMITS MARKETING AUTHORIZATION APPLICATION IN JAPAN FOR ANTICANCER AGENT DENILEUKIN DIFTITOX (GENETIC RECOMBINANT) FOR CUTANEOUS T-CELL LYMPHOMA AND PERIPHERAL T-CELL LYMPHOMA Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has submitted in Japan a marketing authorization application of the anticancer agent denileukin diftitox (genetic recombinant) (generic name, development code: E7777) for relapsed or refractory Cutaneous T-cell Lymphoma (CTCL) and Peripheral T-cell Lymphoma (PTCL). This application is based on data from a multicenter, open-label, single-arm Phase II clinical study (study 205) conducted in Japan for patients with relapsed or refractory CTCL or PTCL to evaluate the efficacy and safety of this agent. This study achieved the primary endpoint and exceeded a predetermined threshold with statistical significance: the objective response rate (ORR) of CTCL and PTCL patients in total (n=36) was 36.1% (95% confidence interval (CI): 20.8-53.8). The ORRs of each subtype were 31.6% (95% CI：12.6-56.6) for CTCL (n=19) and 41.2% (95%CI: 18.4-67.1) for PTCL (n=17). The five most frequent adverse events observed in this study were increased aspartate aminotransferase (AST) (89.2%), increased alanine aminotransferase (ALT) (86.5%), hypoalbuminaemia (70.3%), lymphopenia (70.3%), and pyrexia (51.4%). Denileukin diftitox (genetic recombinant) is a fusion protein of the receptor-binding portion of interleukin-2 (IL-2) and diphtheria toxin that specifically binds to the IL-2 receptor on the surface of tumoral lymphocyte. -
A Bispecific Enediyne-Energized Fusion Protein Targeting Both Epidermal Growth Factor Receptor and Insulin-Like Growth Factor 1
www.impactjournals.com/oncotarget/ Oncotarget, 2017, Vol. 8, (No. 16), pp: 27286-27299 Research Paper A bispecific enediyne-energized fusion protein targeting both epidermal growth factor receptor and insulin-like growth factor 1 receptor showing enhanced antitumor efficacy against non- small cell lung cancer Xiao-Fang Guo1, Xiao-Fei Zhu2,3, Hai-Ying Cao1, Gen-Shen Zhong4, Liang Li5, Bao-Guo Deng1, Ping Chen1, Pei-Zhen Wang1, Qing-Fang Miao5, Yong-Su Zhen5 1Department of Microbiology, School of Basic Medical Sciences, Xinxiang Medical University, Xinxiang, China 2Department of Clinical Immunology, School of Laboratory Medicine, Xinxiang Medical University, Xinxiang, China 3Henan Collaborative Innovation Center of Molecular Diagnosis and Laboratory Medicine, Xinxiang, China 4Laboratory of Cancer Biotherapy, Institute of Neurology, The First Affiliated Hospital of Xinxiang Medical University, Weihui, China 5Department of Oncology, Institute of Medicinal Biotechnology, Chinese Academy of Medical Sciences and Perking Union Medical College, Beijing, China Correspondence to: Xiao-Fang Guo, email: [email protected] Yong-Su Zhen, email: [email protected] Keywords: EGFR, IGF-1R, lidamycin, bispecific fusion protein, NSCLC Received: July 04, 2016 Accepted: February 20, 2017 Published: March 06, 2017 Copyright: Guo et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC-BY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited ABSTRACT Epidermal growth factor receptor (EGFR) and insulin-like growth factor 1 receptor (IGF-1R) both overexpressed on non-small cell lung cancer (NSCLC) and are known cooperatively to promote tumor progression and drug resistance. This study was to construct a novel bispecific fusion protein EGF-IGF-LDP-AE consisting of EGFR and IGF-IR specific ligands (EGF and IGF-1) and lidamycin, an enediyne antibiotic with potent antitumor activity, and investigate its antitumor efficacy against NSCLC. -
Farrukh Javaid Malik
I Farrukh Javaid Malik THESIS PRESENTED TO OBTAIN THE GRADE OF DOCTOR OF THE UNIVERSITY OF BORDEAUX Doctoral School, SP2: Society, Politic, Public Health Specialization Pharmacoepidemiology and Pharmacovigilance By Farrukh Javaid Malik “Analysis of the medicines panorama in Pakistan – The case of antimicrobials: market offer width and consumption.” Under the direction of Prof. Dr. Albert FIGUERAS Defense Date: 28th November 2019 Members of Jury M. Francesco SALVO, Maître de conférences des universités – praticien hospitalier, President Université de Bordeaux M. Albert FIGUERAS, Professeur des universités – praticien hospitalier, Director Université Autonome de Barcelone Mme Antonia AGUSTI, Professeure, Vall dʹHebron University Hospital Referee Mme Montserrat BOSCH, Praticienne hospitalière, Vall dʹHebron University Hospital Referee II Abstract A country’s medicines market is an indicator of its healthcare system, the epidemiological profile, and the prevalent practices therein. It is not only the first logical step to study the characteristics of medicines authorized for marketing, but also a requisite to set up a pharmacovigilance system, thus promoting rational drug utilization. The three medicines market studies presented in the present document were conducted in Pakistan with the aim of describing the characteristics of the pharmaceutical products available in the country as well as their consumption at a national level, with a special focus on antimicrobials. The most important cause of antimicrobial resistance is the inappropriate consumption of antimicrobials. The results of the researches conducted in Pakistan showed some market deficiencies which could be addressed as part of the national antimicrobial stewardship programmes. III Résumé Le marché du médicament d’un pays est un indicateur de son système de santé, de son profil épidémiologique et des pratiques [de prescription] qui y règnent. -
A Randomized, Open-Label, Phase 3 Trial of Brentuximab Vedotin
Title: A Randomized, Open-Label, Phase 3 Trial of brentuximab vedotin (SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Patients With CD30-Positive Cutaneous T- Cell Lymphoma NCT Number: NCT01578499 Protocol Approve Date: 02 December 2014 Certain information within this protocol has been redacted (ie, specific content is masked irreversibly from view with a black/blue bar) to protect either personally identifiable information (PPD) or company confidential information (CCI). This may include, but is not limited to, redaction of the following: Named persons or organizations associated with the study. Proprietary information, such as scales or coding systems, which are considered confidential information under prior agreements with license holder. • Other information as needed to protect confidentiality of Takeda or partners, personal information, or to otherwise protect the integrity of the clinical study. Brentuximab vedotin (SGN-35) Clinical Study Protocol C25001 Amendment 5, EudraCT: 2010-024215-14 CLINICAL STUDY PROTOCOL C25001 AMENDMENT 5 Brentuximab vedotin (SGN-35) A Randomized, Open-Label, Phase 3 Trial of brentuximab vedotin (SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Patients With CD30-Positive Cutaneous T-Cell Lymphoma Protocol Number: C25001 Indication: CD30 Positive Cutaneous T-Cell Lymphoma Phase: 3 Sponsor: Millennium Pharmaceuticals, Inc. EudraCT Number: 2010-024215-14 Therapeutic Area: Oncology Protocol History Original 11 July 2011 Amendment 1 21 December 2011 Amendment 2 24 February 2012 Amendment 3 04 March 2013 Amendment 4 03 July 2013 Amendment 5 02 December 2014 Millennium Pharmaceuticals, Inc. 40 Landsdowne Street Cambridge, MA USA 02139 Telephone: +1 (617) 679-7000 Approved by: Note: If this document was approved electronically, the electronic approval signatures may be found at the end of the document. -
Role of Denileukin Diftitox in the Treatment of Persistent Or Recurrent Cutaneous T-Cell Lymphoma
Cancer Management and Research Dovepress open access to scientific and medical research Open Access Full Text Article R EVIEW Role of denileukin diftitox in the treatment of persistent or recurrent cutaneous T-cell lymphoma Frederick Lansigan1 Abstract: Denileukin diftitox (Ontak®) is indicated for the treatment of patients with persistent Diane M Stearns1 or recurrent cutaneous T-cell lymphoma (CTCL), a rare lymphoproliferative disorder of the Francine Foss2 skin. Denileukin diftitox was the first fusion protein toxin approved for the treatment of a human disease. This fusion protein toxin combines the IL2 protein with diphtheria toxin, and targets the 1Hematology/Oncology, Norris Cotton Cancer Center, Dartmouth CD25 subunit of the IL2 receptor, resulting in the unique delivery of a cytocidal agent to CD-25 Hitchcock Medical Center, Lebanon, bearing T-cells. Historically, immunotherapy targeting malignant T-cells including monoclonal 2 NH, USA; Yale Comprehensive antibodies has been largely ineffective as cytocidal agents compared to immunotherapy directed Cancer Center, Yale University School of Medicine, New Haven, CT, USA against B-cells such as rituximab. This review will summarize the development of denileukin diftitox, its proposed mechanism of action, the pivotal clinical trials that led to its FDA approval, For personal use only. the improvements in quality of life, and the common toxicities experienced during the treatment of patients with CTCL. CTCL is often a chronic progressive lymphoma requiring the sequential use of treatments -
February 2021 EPS Pipeline Report
Pipeline Report February 2021 Pipeline Report February 2021 © 2021 Envolve. All rights reserved. Page 1 This quarterly at-a-glance publication is developed by our Clinical Pharmacy Drug Information team to increase your understanding of the drug pipeline, Table of Contents ensuring you’re equipped with insights to prepare for shifts in pharmacy benefit management. In this issue, you’ll learn more about key themes and notable drugs referenced in the following points. COVID-19 1 > Veklury is currently the only agent that is FDA-approved for the treatment of COVID-19. Three additional therapeutics and two vaccines have been granted Emergency Use Authorization (EUA), and at least three more vaccines are Recent Specialty Drug Approvals1 4 expected to receive an EUA in the relatively near future. > The previous quarter noted the approval of several breakthrough therapies for rare or ultra-rare conditions, which previously had no available FDA-approved Recent Non-Specialty Drug Approvals 9 treatments — Zokinvy for Hutchinson-Gilford progeria syndrome and progeroid laminopathies, Oxlumo for primary hyperoxaluria type 1, and Imcivree for genetically mediated obesity. Upcoming Specialty Products 10 > Other notable approvals include: Lupkynis — the first oral therapy approved for lupus nephritis; Orladeyo — the first oral therapy approved as prophylaxis of hereditary angioedema attacks;Cabenuva – the first long-acting injectable antiretroviral therapy intended as maintenance treatment of HIV; and Breyanzi — Upcoming Non-Specialty Products 18 the