Emtree Terms Changed in January 2018

Total Page:16

File Type:pdf, Size:1020Kb

Emtree Terms Changed in January 2018 Emtree Terms Changed in January 2018 Emtree Terms Added and Changed (January 2018) This is an overview of new terms added and changes made in the first Emtree release in 2018. Overall, Emtree shows a net growth of 1,308 preferred terms (250 drug terms and 1,058 non-drug terms) compared with the previous version released in September 2017. In total Emtree now counts 79,984 preferred terms. Because the terms added include replacements for existing preferred terms (which become synonyms of the new terms) as well as completely new concepts, the number of terms added exceeds the net growth in Emtree. Other changes could include the merging of two or more existing preferred terms into a single concept. The terms added and changed are summarized below and specified in detail on the following pages. Emtree Terms Added in January 2018 1,397 new terms (including 88 replacement terms and promoted synonyms) have been added to Emtree as preferred terms in version January 2018 (compared to September 2017): 295 drug terms (terms assigned to the Chemicals and Drugs facet). 1,102 non-drug terms (terms not assigned as Chemicals and Drugs). The new terms (including the replacement terms and the promoted synonyms) are listed as Terms Added on the following pages. Note that many of these terms will have been indexed prior to 2018 (typically as candidate terms), sometimes for several years, before they were added to Emtree. Emtree Terms Changed in January 2018 88 terms (46 drug terms and 42 non-drug terms) from Emtree September 2017 have been replaced by 85 different terms in January 2018 (45 drug terms and 40 non-drug terms). Of these, 78 terms (43 drug terms and 35 non-drug terms) are new (e.g. new generic names for drug chemical names) and have been assigned creation date 2018; the remaining 7 replacement terms (2 drug terms and 5 non-drug terms) were already present in Emtree. No drug terms were replaced by a non-drug term, 1 non-drug term was replaced by a drug term. No preferred terms were deleted. Changes are presented in alphabetical order of the new terms. Emtree Terms Added in January 2018 2 Drug terms [5,10,15,20 tetrakis(4 carboxyphenyl) 21h,23h calcium chloride plus dextrose plus lactic acid porphine]manganese(iii) chloride plus magnesium chloride plus sodium AAA protein bicarbonate plus sodium chloride ABC transporter D1 calcium chloride plus lactic acid plus magnesium ABC transporter subfamily A chloride plus sodium bicarbonate plus sodium ABC transporter subfamily B chloride ABC transporter subfamily D calcium chloride plus magnesium chloride plus adafosbuvir lactic acid plus potassium chloride plus adarigiline sodium bicarbonate plus sodium chloride plus adavivint sodium phosphate adavosertib calcium chloride plus magnesium chloride plus ADP ribosyl cyclase potassium chloride plus sodium bicarbonate ADP ribosyl cyclase/cyclic ADP ribose hydrolase 1 plus sodium chloride plus sodium phosphate aldo keto reductase calcium plus colecalciferol aldo keto reductase family 1 member B10 camidanlumab aldo keto reductase family 1 member C2 camidanlumab tesirine aldo keto reductase family 1 member C3 canerpaturev alirinetide capivasertib alobresib cell adhesion molecule 1 angiopoietin related protein cell free nucleic acid angiopoietin related protein 4 channelrhodopsin anoctamin circulating microRNA anoctamin 1 circulating tumor DNA antiacidosis agent cobicistat plus darunavir plus emtricitabine plus antihypokalemic agent tenofovir alafenamide antineoplastic monoclonal antibody contezolid antroquinonol contezolid acefosamil apolipoprotein L cyclosporine apolipoprotein L1 daikenchuto arfolitixorin damistimagene matitucel asivatrep danvatirsen atabecestat darvadstrocel atidortoxumab davamotecan pegadexamer avapritinib decitabine plus tetrahydrouridine aversive agent deleted in azoospermia protein 1 B cell lymphoma/leukemia 10 delgocitinib bacteriocin factor demplatin pegraglumer baculoviral IAP repeat containing protein 3 deoxynucleoside triphosphate bb 301 triphosphohydrolase SAMHD1 beinaglutide desidustat bemarituzumab desmetramadol bemcentinib dextrose plus lactic acid plus magnesium chloride benzalkonium chloride plus chlorhexidine plus potassium chloride plus sodium digluconate bicarbonate plus sodium chloride berdazimer sodium difamilast berlimatoxumab disks large homolog 1 bestrophin disks large homolog 4 birtamimab DNA (cytosine 5) methyltransferase 1 bone marrow stromal antigen 2 DNA mismatch repair protein MSH2 C-C motif chemokine 18 DNA repair protein XRCC1 calcium chloride plus dextrose plus lactic acid double strand break repair protein MRE11 plus magnesium chloride plus potassium dual oxidase chloride plus sodium bicarbonate plus sodium efepoetin alfa chloride eflenograstim alfa elenbecestat Emtree Terms Added in January 2018 3 elsulfavirine lenabasum emiplacel letrozole plus ribociclib enarodustat leukocyte immunoglobulin like receptor enistimgene setitucel subfamily B member 1 enterotoxin receptor leukocyte surface antigen CD53 environmental marker lifirafenib exebacase lipopolysaccharide receptor F box/WD repeat containing protein 7 lonapegsomatropin fatty acid binding protein 3 loncastuximab fenebrutinib loncastuximab tesirine fidanacogene elaparvovec lotamilast fimepinostat loxicodegol firibastat lumasiran flotetuzumab magnesium chloride plus potassium chloride plus fluticasone furoate plus umeclidinium plus sodium bicarbonate plus sodium chloride plus vilanterol sodium phosphate foliglurax marstacimab food ingredient mavelertinib forkhead box protein L2 MDS1 and EVI1 complex locus protein fulacimstat metallocene garvagliptin milademetan glecaprevir plus pibrentasvir minesapride Glycyrrhiza glabra root miralimogene ensolisbac Glycyrrhiza uralensis root mosunetuzumab glycyrrhizae radix mucosa associated lymphoid tissue lymphoma goshajinkigan translocation protein 1 gosuranemab multidrug resistance associated protein guanine nucleotide exchange C9orf72 nadofaragene firadenovec heat shock transcription factor nalotimagene carmaleucel heat stable enterotoxin receptor agonist nangibotide hemolysin factor nectin heterogeneous nuclear ribonucleoprotein A1 netrin receptor histone acetyltransferase KAT5 netrin receptor DCC hmed ides nsc500 homeobox protein Meis1 nucleolysin TIA 1 isoform p40 homeobox protein Nkx 2.1 olinciguat hyaluronate synthetase olorofim ianalumab onasemnogene abeparvovec iberdomide oncolytic reovirus iladatuzumab opaganib iladatuzumab vedotin opigolix imlifidase opiranserin immunological antineoplastic agent opolimogene capmilisbac in 3012 oxalate decarboxylase inhibitor of growth protein 1 P type ATPase Kampo medicine (drug) pamiparib katanin parsaclisib Kiss1 receptor partner and localizer of BRCA2 Krev interaction trapped protein 1 pavinetant Lac factor pegerythropoietin lactic acid plus magnesium chloride plus sodium pegzilarginase bicarbonate plus sodium chloride pemlimogene merolisbac ladiratuzumab peroxisomal targeting signal 1 receptor ladiratuzumab vedotin peroxisomal targeting signal 2 receptor lanacogene vosiparvovec peroxisome biogenesis factor 2 lazertinib petesicatib leflutrozole phytochemical Emtree Terms Added in January 2018 4 pixatimod talacotuzumab platelet endothelial cell adhesion molecule 1 target of rapamycin complex subunit LST8 platelet-rich fibrin tasadenoturev plocabulin tasipimidine poly ADP ribose binding protein tbx 1400 polyethylene glycol dimethacrylate hydrogel telacebec potassium bicarbonate plus potassium citrate tesirine prasinezumab Thy 1 membrane glycoprotein pre B cell leukemia transcription factor 1 tigolaner protein CBFA2T1 tilsotolimod protein kinase Mer timrepigene emparvovec ralaniten tiragolumab rapamycin-insensitive companion of mTOR tirvalimogene teraplasmid Ras related protein Rab 27A tislelizumab raspberry leaf extract tralesinidase alfa receptor for activated C kinase transactinide receptor type tyrosine protein phosphatase C transcription factor 4 redasemtide transcription intermediary factor 1 beta reduced nicotinamide adenine dinucleotide transcriptional activator GLI3 phosphate oxidase 5 transcriptional regulator ATRX regulatory associated protein of mTOR triose sugar alcohol relatlimab tumor necrosis factor ligand superfamily member relmapirazin 12 remlarsen tumor necrosis factor receptor superfamily renapersen member 12A retinal specific ATP binding cassette transporter tumor necrosis factor receptor superfamily RhoC guanine nucleotide binding protein member 6 riamilovir tumor necrosis factor receptor superfamily rice bran oil member 8 rikkunshito tumor necrosis factor receptor superfamily rovazolac member 9 SAP90/PSD95 associated protein ubiquitin carboxyl terminal hydrolase 7 seliforant ubiquitin carboxyl terminal hydrolase CYLD serine peptidase inhibitor Kazal type umbralisib serine peptidase inhibitor Kazal type 5 uproleselan serine protease HTRA1 vactosertib serine/threonine protein kinase WNK1 valziflocept setrusumab vatinoxan short chain dehydrogenase/reductase vecabrutinib short stature homeobox protein virulence plasmid sialomucin core protein 24 vorasidenib sirtratumab votrisiran sirtratumab vedotin WW domain containing oxidoreductase sofosbuvir plus velpatasvir plus voxilaprevir yokukansan spartalizumab zanubrutinib spherox zenocutuzumab sphingosine kinase inhibitor zinc finger and BTB domain containing protein 16 strobilurin zinc finger E box binding homeobox 2 sultimotide alfa zinc finger protein GLI2 T cell acute lymphocytic leukemia protein 1 zinc transporter 8 T lymphoma invasion and metastasis inducing zolbetuximab protein 1 Emtree
Recommended publications
  • Paediatric Committee (PDCO) Draft Agenda for the Meeting on 09-11 December 2019
    09 December 2019 EMA/PDCO/630621/2019 Inspections, Human Medicines Pharmacovigilance and Committees Division Paediatric Committee (PDCO) Draft agenda for the meeting on 09-11 December 2019 Chair: Koenraad Norga – Vice-Chair: Sabine Scherer 09 December 2019, 08:30- 19:00, room 2D 10 December 2019, 08:30- 19:00, room 2D 11 December 2019, 08:30- 16:00, room 2D Health and safety information In accordance with the Agency’s health and safety policy, delegates are to be briefed on health, safety and emergency information and procedures prior to the start of the meeting. 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 PDCO Committee meeting reports (after the PDCO Opinion is adopted), and on the Opinions and decisions on paediatric investigation plans webpage (after the EMA Decision is issued). 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).
    [Show full text]
  • Combining Immune Checkpoint Inhibitors: Established and Emerging Targets and Strategies to Improve Outcomes in Melanoma
    King’s Research Portal DOI: 10.3389/fimmu.2019.00453 Document Version Publisher's PDF, also known as Version of record Link to publication record in King's Research Portal Citation for published version (APA): Khair, D. O., Bax, H. J., Mele, S., Crescioli, S., Pellizzari, G., Khiabany, A., Nakamura, M., Harris, R. J., French, E., Hoffmann, R. M., Williams, I. P., Cheung, K. K. A., Thair, B., Beales, C. T., Touizer, E., Signell, A. W., Tasnova, N. L., Spicer, J. F., Josephs, D. H., ... Karagiannis, S. N. (2019). Combining Immune Checkpoint Inhibitors: Established and Emerging Targets and Strategies to Improve Outcomes in Melanoma. Frontiers in Immunology , (MAR), [453]. https://doi.org/10.3389/fimmu.2019.00453 Citing this paper Please note that where the full-text provided on King's Research Portal is the Author Accepted Manuscript or Post-Print version this may differ from the final Published version. If citing, it is advised that you check and use the publisher's definitive version for pagination, volume/issue, and date of publication details. And where the final published version is provided on the Research Portal, if citing you are again advised to check the publisher's website for any subsequent corrections. General rights Copyright and moral rights for the publications made accessible in the Research Portal are retained by the authors and/or other copyright owners and it is a condition of accessing publications that users recognize and abide by the legal requirements associated with these rights. •Users may download and print one copy of any publication from the Research Portal for the purpose of private study or research.
    [Show full text]
  • Multimodality Treatment in Metastatic Gastric Cancer: from Past to Next Future
    cancers Review Multimodality Treatment in Metastatic Gastric Cancer: From Past to Next Future Alessandro Parisi 1,2,* , Giampiero Porzio 1,2 and Corrado Ficorella 1,2 1 Medical Oncology, St. Salvatore Hospital, University of L’Aquila, 67100 L’Aquila, Italy; [email protected] (G.P.); corrado.fi[email protected] (C.F.) 2 Department of Biotechnology and Applied Clinical Sciences, University of L’Aquila, 67100 L’Aquila, Italy * Correspondence: [email protected]; Tel.: +39-086-236-8709; Fax: +39-086-236-8682 Received: 24 July 2020; Accepted: 9 September 2020; Published: 11 September 2020 Simple Summary: Gastric cancer remains an incurable disease in most of the cases. Anyway, the progress achieved over the last decade in terms of knowledge of its biology and available therapeutic options, together with a greater attention to the concept of supportive care, led to a progressive and incremental survival benefit in metastatic gastric cancer patients. In this review we summarize the current standard management and the major completed or ongoing clinical trials involving systemic, surgical or locoregional treatment of metastatic gastric cancer along with emerging concepts likely to improve patients’ outcome in the next future. Abstract: Gastric cancer (GC) still remains an incurable disease in almost two-thirds of the cases. However, a deeper knowledge of its biology in the last few years has revealed potential biomarkers suitable for tailored treatment with targeted agents. This aspect, together with the improvement in early supportive care and a wiser use of the available cytotoxic drugs across multiple lines of treatment, has resulted in incremental and progressive survival benefits.
    [Show full text]
  • On the Horizon: Immuno-Oncology (I-O) Combinations
    Immuno-Oncology (I-O) Combinations • Jeffrey A. Sosman, MD • Robert H. Lurie Comprehensive Cancer Center of Northwestern University The Cancer–Immunity Cycle Daniel Chen and Ira Mellman Immunity, Volume 39, Issue 1, 2013, 1 - 10 The Cancer–Immunity Cycle Daniel Chen and Ira Mellman Immunity, Volume 39, Issue 1, 2013, 1 - 10 Stimulatory and Inhibitory Factors in the Cancer-Immunity Cycle Each step of the Cancer-Immunity Cycle requires the coordination of numerous factors, both stimulatory and inhibitory in nature. Stimulatory factors shown in green promote immunity, ... Where will Improvements come from? • Combinations: – Based on Template: anti-PD-1/PD-L1 or with anti-PD- 1/anti-CTLA-4 • Block other co-inhibitory: LAG3, TIM3, KIR, VISTA • Activate co-stimulatory: 4-1BB, OX-40, GITR, CD27, ICOS • Block inhibitory molecules- IDOi, TGFbi, CSF1Ri, anti-IL-6 or anti- IL-10 • Effect trafficking- anti-VEGF, CCL5, CXCR4i • Vaccines- TVEC- oncolytic virus, Neoantigen, other cellular • Adoptive Cellular therapy- TIL, CAR-T cells, TCR T-cells Where will Improvements come from? • Combinations: – Based on Template: anti-PD-1/PD-L1 or with anti-PD- 1/anti-CTLA-4 • Signal Inhibition, BRAF directed (BRAFi+MEKi), MEKi, PI3K inhibition (PTEN effects) • Cytokines- IL-2, IFN a,b,g,, Directed cytokines (FAP-IL-2v or CEA-IL-2v) • Epigenetic modulation- gene expression and EVR expression • Microbiome modification- fecal transplants • Chemotherapy other cytotoxics • Localized Irradiation SBRT, SRS T cells in Tumors Express Multiple Immunoinhibitory Receptors
    [Show full text]
  • Looking for Therapeutic Antibodies in Next Generation Sequencing Repositories
    bioRxiv preprint doi: https://doi.org/10.1101/572958; this version posted March 10, 2019. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. It is made available under aCC-BY 4.0 International license. Title: Looking for Therapeutic Antibodies in Next Generation Sequencing Repositories. Authors: Konrad Krawczyk1*, Matthew Raybould2, Aleksandr Kovaltsuk2, Charlotte M. Deane2 1 NaturalAntibody, Hamburg, Germany 2 Oxford University Department of Statistics, Oxford, UK *Correspondence to [email protected] Abstract: Recently it has become possible to query the great diversity of natural antibody repertoires using Next Generation Sequencing (NGS). These methods are capable of producing millions of sequences in a single experiment. Here we compare Clinical Stage Therapeutic antibodies to the ~1b sequences from 60 independent sequencing studies in the Observed Antibody Space Database. Of the 242 post Phase I antibodies, we find 16 with sequence identity matches of 95% or better for both heavy and light chains. There are also 54 perfect matches to therapeutic CDR-H3 regions in the NGS outputs, suggesting a nontrivial amount of convergence between naturally observed sequences and those developed artificially. This has potential implications for both the discovery of antibody therapeutics and the legal protection of commercial antibodies. Introduction Antibodies are proteins in jawed vertebrates that recognize noxious molecules (antigens) for elimination. An organism expresses millions of diverse antibodies to increase the chances that some of them will be able to bind the foreign antigen, initiating the adaptive immune response.
    [Show full text]
  • The Evolving Landscape of `Next-Generation' Immune
    European Journal of Cancer 117 (2019) 14e31 Available online at www.sciencedirect.com ScienceDirect journal homepage: www.ejcancer.com Review The evolving landscape of ‘next-generation’ immune checkpoint inhibitors: A review Luca Mazzarella a, Bruno Achutti Duso a, Dario Trapani a,b, Carmen Belli a, Paolo D’Amico a,b, Emanuela Ferraro a,b, Giulia Viale a,b, Giuseppe Curigliano a,b,* a New Drugs and Early Drug Development for Innovative Therapies Division, IEO, European Institute of Oncology IRCCS, Milan, Italy b University of Milano, Department of Hematology and Hemato-Oncology, Italy Received 17 March 2019; received in revised form 23 April 2019; accepted 26 April 2019 Available online 21 June 2019 KEYWORDS Abstract ‘First-generation’ immune checkpoint inhibitors targeting Cytotoxic T-Lympho- Next generation cyte Antigen 4 (CTLA4) and Programmed death-ligand 1 (PD(L)1) have undoubtedly revolu- immune-checkpoints; tionised the treatment of multiple cancers in the advanced setting. Targeting signalling LAG3; pathways other than core inhibitory modules may strongly impact the outcome of the antitu- TIGIT; mour immune response. Drugs targeting these pathways (‘next-generation’ immune modula- TIM3; tors, NGIMs) constitute a major frontier in translational research and have generated 4-1BB; unprecedented scientific and financial investment. Here, we systematically reviewed published IDO1; literature, abstracts from major cancer conferences and pharma pipelines to identify NGIMs GITR; that have reached clinical development. We identified 107 molecules targeting 16 pathways, Colony stimulating which we classified into 6 groups according to function (inhibitory vs stimulatory) and cell factor-1 (CSF-1) of predominant expression (lymphoid, non-lymphoid and natural killer).
    [Show full text]
  • Targeting Costimulatory Molecules in Autoimmune Disease
    Targeting costimulatory molecules in autoimmune disease Natalie M. Edner1, Gianluca Carlesso2, James S. Rush3 and Lucy S.K. Walker1 1Institute of Immunity & Transplantation, Division of Infection & Immunity, University College London, Royal Free Campus, London, UK NW3 2PF 2Early Oncology Discovery, Early Oncology R&D, AstraZeneca, Gaithersburg, MD, USA 3Autoimmunity, Transplantation and Inflammation Disease Area, Novartis Institutes for Biomedical Research, Basel, Switzerland *Correspondence: Professor Lucy S.K. Walker. Institute of Immunity & Transplantation, Division of Infection & Immunity, University College London, Royal Free Campus, London, UK NW3 2PF. Tel: +44 (0)20 7794 0500 ext 22468. Email: [email protected]. 1 Abstract Therapeutic targeting of immune checkpoints has garnered significant attention in the area of cancer immunotherapy, and efforts have focused in particular on the CD28 family members CTLA-4 and PD-1. In autoimmunity, these same pathways can be targeted to opposite effect, to curb the over- exuberant immune response. The CTLA-4 checkpoint serves as an exemplar, whereby CTLA-4 activity is blocked by antibodies in cancer immunotherapy and augmented by the provision of soluble CTLA-4 in autoimmunity. Here we review the targeting of costimulatory molecules in autoimmune disease, focusing in particular on the CD28 family and TNFR family members. We present the state-of-the-art in costimulatory blockade approaches, including rational combinations of immune inhibitory agents, and discuss the future opportunities and challenges in this field. 2 The risk of autoimmune disease is an inescapable consequence of the manner in which the adaptive immune system operates. To ensure effective immunity against a diverse array of unknown pathogens, antigen recognition systems based on random gene rearrangement and mutagenesis have evolved to anticipate the antigenic universe.
    [Show full text]
  • An Ipsos Point of View
    THE AMAZING RACE: NEXT-GEN IMMUNO- ONCOLOGY EDITION An Ipsos Point of View By Eric Blouin THE AMAZING RACE: After several false starts (remember OX40 NEXT-GEN IMMUNO- and the infamous IDO1?) and recent missteps (hello ICOS, we are looking at you!), two ONCOLOGY EDITION promising new immuno-oncology (IO) classes Summary could soon complement the reigning champions, In the search for next-generation immuno- anti-PD(L)1s. At ASCO 2020, Roche/Genentech oncology agents beyond the anti-PD-(L)1s, created buzz for tiragolumab (an anti-TIGIT two front-runners have finally emerged: candidate) with an update for CITYSCAPE, its BMS’ relatlimab (anti-LAG3) and Roche/ phase 2 NSCLC trial. More recently, BMS upped Genentech’s tiragolumab (anti-TIGIT). the ante by announcing positive results for The assets are complementary to anti- its RELATIVITY-047, a phase 2/3 trial for PD-(L)1s, potentially providing increased relatlimab, its anti-LAG-3 asset. efficacy (without incremental toxicities). In this article, we’ll analyze the strengths and Both companies have heavily invested in weaknesses of each class, and anticipate how broad clinical programs to expand beyond the assets’ initial lead indications. There the race might play out and what its impact is also intense competitive R&D activity. on the cancer landscape could be. Unlike most While relatlimab is likely to be approved contests, this one could have more than one first (based on having recently announced winner! a positive pivotal trial), its lead indication (metastatic melanoma) may not initially be a significant growth driver for BMS. In contrast, tiragolumab’s lead indication, 1L mNSCLC (PD-L1 high patients) holds greater immediate commercial benefit.
    [Show full text]
  • Antibodies to Watch in 2021 Hélène Kaplona and Janice M
    MABS 2021, VOL. 13, NO. 1, e1860476 (34 pages) https://doi.org/10.1080/19420862.2020.1860476 PERSPECTIVE Antibodies to watch in 2021 Hélène Kaplona and Janice M. Reichert b aInstitut De Recherches Internationales Servier, Translational Medicine Department, Suresnes, France; bThe Antibody Society, Inc., Framingham, MA, USA ABSTRACT ARTICLE HISTORY In this 12th annual installment of the Antibodies to Watch article series, we discuss key events in antibody Received 1 December 2020 therapeutics development that occurred in 2020 and forecast events that might occur in 2021. The Accepted 1 December 2020 coronavirus disease 2019 (COVID-19) pandemic posed an array of challenges and opportunities to the KEYWORDS healthcare system in 2020, and it will continue to do so in 2021. Remarkably, by late November 2020, two Antibody therapeutics; anti-SARS-CoV antibody products, bamlanivimab and the casirivimab and imdevimab cocktail, were cancer; COVID-19; Food and authorized for emergency use by the US Food and Drug Administration (FDA) and the repurposed Drug Administration; antibodies levilimab and itolizumab had been registered for emergency use as treatments for COVID-19 European Medicines Agency; in Russia and India, respectively. Despite the pandemic, 10 antibody therapeutics had been granted the immune-mediated disorders; first approval in the US or EU in 2020, as of November, and 2 more (tanezumab and margetuximab) may Sars-CoV-2 be granted approvals in December 2020.* In addition, prolgolimab and olokizumab had been granted first approvals in Russia and cetuximab saratolacan sodium was first approved in Japan. The number of approvals in 2021 may set a record, as marketing applications for 16 investigational antibody therapeutics are already undergoing regulatory review by either the FDA or the European Medicines Agency.
    [Show full text]
  • Prescrire's Contribution to the WHO Consultation List
    World Health Organization Raffaella Balocco INN Programme Manager Quality Assurance & Safety : Medecines CH 1211 GENEVA 27 SUISSE Paris, November 2, 2017 Prescrire’s contribution to the WHO consultation on List 117 of proposed INNs Prescrire is an independent continuing education organisation for healthcare professionals. It is wholly funded by its subscribers, carries no advertising, and receives no other financial support whatsoever. Both independently since 1981, and with others as part of the Medicines in Europe Forum, the International Society of Drug Bulletins (ISDB) and the International Medication Safety Network (IMSN), Prescrire has been advocating the systematic use by healthcare professionals and patients of international nonproprietary names (INNs), which are clearer, safer and more informative than drug brand names (1-6). Making INNs safer. The principles underlying the creation of INNs are the same that apply to the prevention of medication errors: standardisation, differentiation, and facilitation of logic and redundancy checks (7). However, even with the INN system there is a residual risk of confusion, partly owing to the sheer number of INNs now in circulation. A report from the Council of Europe, which recommends the use of INNs, calls for active participation in the public consultations on proposed INNs organised by the World Health Organization (WHO), in order to identify any risk of confusion during their clinical use (8). Our review group, consisting of members of Prescrire’s editorial staff, including hospital- and community-based health professionals, joined by lecturers in pharmacy and medicine and health professionals from two university hospitals, has examined List 117 in order to participate in the public consultation on this latest list of proposed INNs, published in July 2017 (a)(9).
    [Show full text]
  • Horizon Scanning Status Report, Volume 2
    PCORI Health Care Horizon Scanning System Volume 2, Issue 3 Horizon Scanning Status Report September 2020 Prepared for: Patient-Centered Outcomes Research Institute 1828 L St., NW, Suite 900 Washington, DC 20036 Contract No. MSA-HORIZSCAN-ECRI-ENG-2018.7.12 Prepared by: ECRI Institute 5200 Butler Pike Plymouth Meeting, PA 19462 Investigators: Randy Hulshizer, MA, MS Damian Carlson, MS Christian Cuevas, PhD Andrea Druga, PA-C Marcus Lynch, PhD, MBA Misha Mehta, MS Prital Patel, MPH Brian Wilkinson, MA Donna Beales, MLIS Jennifer De Lurio, MS Eloise DeHaan, BS Eileen Erinoff, MSLIS Cassia Hulshizer, AS Madison Kimball, MS Maria Middleton, MPH Diane Robertson, BA Melinda Rossi, BA Kelley Tipton, MPH Rosemary Walker, MLIS Andrew Furman, MD, MMM, FACEP Statement of Funding and Purpose This report incorporates data collected during implementation of the Patient-Centered Outcomes Research Institute (PCORI) Health Care Horizon Scanning System, operated by ECRI under contract to PCORI, Washington, DC (Contract No. MSA-HORIZSCAN-ECRI-ENG-2018.7.12). The findings and conclusions in this document are those of the authors, who are responsible for its content. No statement in this report should be construed as an official position of PCORI. An intervention that potentially meets inclusion criteria might not appear in this report simply because the Horizon Scanning System has not yet detected it or it does not yet meet inclusion criteria outlined in the PCORI Health Care Horizon Scanning System: Horizon Scanning Protocol and Operations Manual. Inclusion or absence of interventions in the horizon scanning reports will change over time as new information is collected; therefore, inclusion or absence should not be construed as either an endorsement or rejection of specific interventions.
    [Show full text]
  • Antibodies for the Treatment of Brain Metastases, a Dream Or a Reality?
    pharmaceutics Review Antibodies for the Treatment of Brain Metastases, a Dream or a Reality? Marco Cavaco, Diana Gaspar, Miguel ARB Castanho * and Vera Neves * Instituto de Medicina Molecular, Faculdade de Medicina, Universidade de Lisboa, Av. Prof. Egas Moniz, 1649-028 Lisboa, Portugal * Correspondence: [email protected] (M.A.R.B.C.); [email protected] (V.N.) Received: 19 November 2019; Accepted: 28 December 2019; Published: 13 January 2020 Abstract: The incidence of brain metastases (BM) in cancer patients is increasing. After diagnosis, overall survival (OS) is poor, elicited by the lack of an effective treatment. Monoclonal antibody (mAb)-based therapy has achieved remarkable success in treating both hematologic and non-central-nervous system (CNS) tumors due to their inherent targeting specificity. However, the use of mAbs in the treatment of CNS tumors is restricted by the blood–brain barrier (BBB) that hinders the delivery of either small-molecules drugs (sMDs) or therapeutic proteins (TPs). To overcome this limitation, active research is focused on the development of strategies to deliver TPs and increase their concentration in the brain. Yet, their molecular weight and hydrophilic nature turn this task into a challenge. The use of BBB peptide shuttles is an elegant strategy. They explore either receptor-mediated transcytosis (RMT) or adsorptive-mediated transcytosis (AMT) to cross the BBB. The latter is preferable since it avoids enzymatic degradation, receptor saturation, and competition with natural receptor substrates, which reduces adverse events. Therefore, the combination of mAbs properties (e.g., selectivity and long half-life) with BBB peptide shuttles (e.g., BBB translocation and delivery into the brain) turns the therapeutic conjugate in a valid approach to safely overcome the BBB and efficiently eliminate metastatic brain cells.
    [Show full text]