Annual Report 2020 We Are a Science-Led Global Healthcare Company
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Corporate Governance
Strategic report Governance and remuneration Financial statements Investor information Corporate Governance In this section Chairman’s Governance statement 78 The Board 80 Corporate Executive Team 83 Board architecture 85 Board roles and responsibilities 86 Board activity and principal decisions 87 Our purpose, values and culture 90 The Board’s approach to engagement 91 Board performance 94 Board Committee information 96 Our Board Committee reports 97 Section 172 statement 108 Directors’ report 109 GSK Annual Report 2020 77 Chairman’s Governance statement In last year’s Governance statement, I explained that our primary Education and focus on Science objective for 2020 was to ensure there was clarity between the Given the critical importance of strengthening the pipeline, Board and management on GSK’s execution of strategy and its the Board has benefitted from devoting a higher proportion of operational priorities. We have aligned our long-term priorities its time in understanding the science behind our strategy and of Innovation, Performance and Trust powered by culture testing its application. It is important that the Board has a and agreed on the metrics to measure delivery against them. working understanding of the key strategic themes upon The Board’s annual cycle of meetings ensures that all major which our R&D strategy is based. These themes have been components of our strategy are reviewed over the course complemented by Board R&D science thematic deep dives. of the year. Our focus was on the fundamentals of our strategy: human The COVID-19 pandemic impacted and dominated all our genetics, the immune system and AI and ML, as well as to lives for the majority of 2020. -
Dovato, INN-Dolutegravir, Lamivudine
26 April 2019 EMA/267082/2019 Committee for Medicinal Products for Human Use (CHMP) Assessment report Dovato International non-proprietary name: dolutegravir / lamivudine Procedure No. EMEA/H/C/004909/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Downloaded from wizmed.com 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, 2019. Reproduction is authorised provided the source is acknowledged. Table of contents 1. Background information on the procedure .............................................. 6 1.1. Submission of the dossier ...................................................................................... 6 1.2. Steps taken for the assessment of the product ......................................................... 7 2. Scientific discussion ................................................................................ 8 2.1. Problem statement ............................................................................................... 8 2.1.1. Disease or condition ........................................................................................... 8 2.1.2. Epidemiology .................................................................................................... 9 2.1.3. Biologic features ............................................................................................... -
Second Quarter 2017
Press release Second quarter 2017 Issued: Wednesday, 26 July 2017, London U.K. GSK delivers further progress in Q2 and sets out new priorities for the Group Q2 sales of £7.3 billion, +12% AER, +3% CER Total loss per share of 3.7p, +59% AER, +29% CER; Adjusted EPS of 27.2p, +12% AER, -2% CER Financial highlights • Pharmaceutical sales, £4.4 billion, +12% AER, +3% CER, Vaccines sales, £1.1 billion, +16% AER, +5% CER, Consumer Healthcare sales, £1.9 billion,+10% AER, flat at CER • Group operating margin 28.5%; Pharmaceuticals 33.6%; Vaccines 33.7%; Consumer 17.7% • Total Q2 loss per share of 3.7p reflecting charges resulting from increases in the valuation of Consumer and HIV businesses and new portfolio choices • Updated 2017 guidance: Adjusted EPS growth now expected to be 3% to 5% CER reflecting impact of Priority Review Voucher • H1 Free Cash Flow £0.4 billion (H1 2016: £0.1 billion) • 19p dividend declared for Q2; continue to expect 80p for FY 2017 Product and pipeline highlights • New product sales of £1.7 billion, +62% AER, +47% CER • HIV two drug regimen (dolutegravir and rilpivirine) filed for approval in US and EU • Shingrix filed for approval in Japan • FDA approval received for subcutaneous Benlysta for treatment of SLE New business priorities to 2020 • New priorities to strengthen innovation, improve performance and build trust • Pharmaceutical R&D pipeline reviewed with target over time to allocate 80% of capital to priority assets in two current (Respiratory and HIV/infectious diseases) and two potential (Oncology and Immuno-inflammation) -
The Academy of Medical Sciences Review 2006 Fmedsci Contents
The Academy of Medical Sciences Review 2006 FMedSci Contents 1 The Academy’s objectives and ambitions for medical science 2 A message from our President 4 Executive Director’s report 6 The strength of our Fellowship 8 How we work 10 Progress through partnership 12 Celebrating science 14 Advancing medical science and infl uencing policy 16 Building trust in science 18 Working in partnership with industry 20 The impact of research 22 Creating the next generation of medical scientists 24 Financial information 25 The Academy offi ce 14 16 18 20 22 The Academy’s objectives and ambitions for medical science The Academy of Medical Sciences promotes advances in medical science and campaigns to ensure these are converted as quickly as possible into healthcare benefi ts for society. Our 850 Fellows are the UK’s leading medical scientists from hospitals and general practice, academia, industry and the public service. Our Fellows are central to all we do. The excellence of their science, their contribution to medicine and society and the diversity of their achievements are refl ected throughout this review. The Academy seeks to play a pivotal role in determining the future of medical science in the UK, and the benefi ts that society will enjoy in years to come. We champion the UK’s strengths in medical science, including the unique opportunities for research aff orded by the NHS, encourage the implementation of new ideas and solutions – often through novel partnerships, promote careers and capacity building and help to remove barriers to progress. Throughout all our work the Academy strives to demonstrate our key attributes of excellence, independence, leadership, diversity and fl exibility. -
Dovato, INN-Dolutegravir, Lamivudine
26 April 2019 EMA/267082/2019 Committee for Medicinal Products for Human Use (CHMP) Assessment report Dovato International non-proprietary name: dolutegravir / lamivudine Procedure No. EMEA/H/C/004909/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. 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, 2019. Reproduction is authorised provided the source is acknowledged. Table of contents 1. Background information on the procedure .............................................. 6 1.1. Submission of the dossier ...................................................................................... 6 1.2. Steps taken for the assessment of the product ......................................................... 7 2. Scientific discussion ................................................................................ 8 2.1. Problem statement ............................................................................................... 8 2.1.1. Disease or condition ........................................................................................... 8 2.1.2. Epidemiology .................................................................................................... 9 2.1.3. Biologic features ............................................................................................... -
Third Annual World Congress on the Insulin Resistance Syndrome Atherothrombotic Disease
Reviews/Commentaries/Position Statements PERSPECTIVES ON THE NEWS Third Annual World Congress on the Insulin Resistance Syndrome Atherothrombotic disease ZACHARY T. BLOOMGARDEN, MD thalamic “clock,” which generates protein signals feeding back to create rhythmic behaviors and metabolic changes. Rhyth- his is the second of three articles re- structure, coagulation, and platelets in a mic mRNA expression of clock genes and viewing presentations at the 3rd An- prothrombotic direction (3). adipokines can also be demonstrated in T nual World Congress on the Insulin It is not apparent why insulin resis- mouse visceral adipose tissue, with adi- Resistance Syndrome, San Francisco, Cal- tance should be linked to atherosclerosis. ponectin and resistin responses both at- ifornia, 17–19 November 2005. The thrifty genotype hypothesis suggests tenuated in obese mice. Grant showed an that there is a survival advantage to insu- animal model in which pioglitazone im- proved hepatic rhythmicity. Thus, light, Diabetes and vascular disease lin resistance during periods of feast alter- as well as other stimuli such as ambient At a symposium cosponsored by the In- nating with famine (4), but that chronic ternational Society of Diabetes and Vascu- exposure to high nutrient intake converts temperature, acts via the suprachiasmatic lar Disease (www.dvdres.com), Peter the organism to the phenotype of insulin nucleus to send signals to adipocytes, the Grant (Leeds, U.K.) discussed the role of resistance sydrome and diabetes, with en- endothelium, liver, fibroblasts, cardiac insulin signaling pathways in acute coro- ergy preferentially stored in the liver and myocytes, and multiple other tissues, reg- nary syndrome (ACS), pointing out that in fat and with the clustering of risk mark- ulating reproductive, metabolic, and be- type 2 diabetes is characterized by fasting ers we have come to identify with insulin havioral aspects of life. -
Connecting Immunology
CONNECTING IMMUNOLOGY IN THE TIME OF COVID-19 BSI VIRTUAL CONFERENCE 1-2 DECEMBER 2020 CONNECTINGLOGY NO VID-19 MU OF CO IM TIME IN THE CONNECTING CONNECTING IMMUNOLOGY IN THE TIME OF COVID-19 2 IMMUNOLOGY IN THE TIME OF COVID-19 Welcome On behalf of the BSI’s Congress Committee, I would like to welcome you all to the British Society for Immunology’s virtual conference ‘Connecting immunology in the time of COVID-19’. This is the BSI’s first ever virtual conference at this scale and our committee have worked hard to develop a diverse programme of plenary and parallel sessions covering many of the hot topics within immunology, which we hope will appeal to delegates. With our cutting-edge two-day agenda coupled with our interactive online platform, we aim to bring together immunologists from the UK and worldwide, providing attendees with the latest research developments from Gary Entrican internationally acclaimed leaders in their field. We’re honoured to welcome a number of high-profile speakers including our two keynote presenters from the US, Garry Nolan and Akiko Iwasaki. Additionally, we are privileged to be joined by Sir Patrick Vallance, the Chief Scientific Adviser to the UK Government, who will speak in our COVID-19 themed plenary session alongside Paul Moss, the lead for the UK Coronavirus Immunology Consortium. Among the many other highlights of our programme, I would particularly recommend you attend our Bright Sparks sessions on the first morning, featuring ground-breaking work from promising early career researchers. Additionally, our Coronavirus Panel Discussion on the second afternoon promises to be a fascinating exchange of views on how immunology has fed into the pandemic response. -
Product Monograph for CELSENTRI
PRODUCT MONOGRAPH PrCELSENTRI maraviroc Tablets 150 and 300 mg CCR5 antagonist ViiV Healthcare ULC 245, boulevard Armand-Frappier Laval, Quebec H7V 4A7 Date of Revision: July 05, 2019 Submission Control No: 226222 © 2019 ViiV Healthcare group of companies or its licensor. Trademarks are owned by or licensed to the ViiV Healthcare group of companies. Page 1 of 60 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION.........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 WARNINGS AND PRECAUTIONS..................................................................................4 ADVERSE REACTIONS....................................................................................................9 DRUG INTERACTIONS ..................................................................................................19 DOSAGE AND ADMINISTRATION..............................................................................28 OVERDOSAGE ................................................................................................................31 ACTION AND CLINICAL PHARMACOLOGY ............................................................31 STORAGE AND STABILITY..........................................................................................36 -
Notice of Meeting for the Eighteenth Annual General Meeting (AGM) of Glaxosmithkline Plc
GlaxoSmithKline plc Image HIV virus Notice of Annual General Meeting Thursday 3 May 2018 at 2.30pm This document is important and requires your immediate attention. If you are in any doubt as to what action you should take, you should consult your stockbroker, bank manager, solicitor, accountant or other independent professional adviser immediately. If you have sold or otherwise transferred all of your shares, please pass this document, together with the accompanying documents, to the purchaser or transferee, or to the person who arranged the sale or transfer so they can pass these documents to the person who now holds the shares. 2 29 March 2018 To the holders of the company’s Ordinary Shares and American Depositary Shares. Dear Shareholder, Annual General Meeting 2018 I am pleased to enclose the Notice of Meeting for the eighteenth Annual General Meeting (AGM) of GlaxoSmithKline plc. The AGM will be held on Thursday 3 May 2018 at 2.30pm at the QEII Centre, Broad Sanctuary, Westminster, London SW1P 3EE. If you will not be attending, you may appoint a proxy by completing and returning the enclosed proxy form. Alternatively, you may appoint a proxy electronically via www.shareview.co.uk, www.sharevote.co.uk or, if you hold your shares in CREST, via the CREST system. Notice of your appointment of a proxy should reach the company’s registrar, Equiniti, by 2.30pm on Tuesday 1 May 2018. If you hold your shares through a nominee service, please contact the nominee service provider regarding the process for appointing a proxy. Included in the business of the AGM are resolutions to receive and adopt the Directors’ Report and the Financial Statements for 2017, to approve the Annual report on remuneration for the year ended 31 December 2017 and to confirm the appointment of Deloitte LLP as the company’s auditors. -
List of Medicinal Products Under Additional Monitoring
26 October 2018 EMA/245297/2013 Rev.60 Inspections & Human Medicines Pharmacovigilance List of medicinal products under additional monitoring Related Information: Additional monitoring explained: http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/document_listing/document_listing_000365.jsp Good Pharmacovigilance Practice Module on additional monitoring: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000345.jsp To note: All products added to the list in September 2018 are shown in red font. All products removed from the list are shown with a strikethrough for the period of one month after which they are excluded. Date of Product name Active Substance (s) Reason (s) on list Marketing Authorisation Holder (s) Link to Product Information Inclusion http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/ Abasaglar (previously Abasria) Insulin glargine New biological Eli Lilly Nederland B.V. 002835/human_med_001790.jsp&mid=WC0b01ac058001d124 October 2014 Acarizax (also known in some EU countries as MITIZAX) Standardised allergen extract from house dust mites New Biological ALK-Abelló A/S https://portal.dimdi.de/amispb/doc/pei/Web/2613318-spcde-20170401.pdf May 2016 http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/ Accofil Filgrastim New biological Accord Healthcare Limited 003956/human_med_001798.jsp&mid=WC0b01ac058001d124 October 2014 http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/ Adcetris Brentuximab vedotin -
UNITED STATES SECURITIES and EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D INFORMATION to BE INCLUDED in STATEMENTS FI
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D INFORMATION TO BE INCLUDED IN STATEMENTS FILED PURSUANT TO § 240.13d-1(a) AND AMENDMENTS THERETO FILED PURSUANT TO 240.13d-2(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934 SPERO THERAPEUTICS, INC. (Name of Issuer) Common Stock, Par Value $0.001 (Title of Class of Securities) 84833T 10 3 (CUSIP Number) Victoria A. Whyte GlaxoSmithKline plc 980 Great West Road Brentford, Middlesex TW8 9GS England Telephone: +44 (0)208 047 5000 (Name, Address and Telephone Number of Person Authorized to Receive Notices and Communications) November 6, 2017 (Date of Event which Requires Filing of this Statement) If the filing person has previously filed a statement on Schedule 13G to report the acquisition that is the subject of this Schedule 13D, and is filing this schedule because of §§240.13d-1(e), 240.13d-1(f) or 240.13d-1(g), check the following box. ☐ Note: Schedules filed in paper format shall include a signed original and five copies of the schedule, including all exhibits. See §240.13d-7 for other parties to whom copies are to be sent. * The remainder of this cover page shall be filled out for a reporting person's initial filing on this form with respect to the subject class of securities, and for any subsequent amendment containing information which would alter disclosures provided in a prior cover page. The information required on the remainder of this cover page shall not be deemed to be "filed" for the purpose of Section 18 of the Securities Exchange Act of 1934 ("Act") or otherwise subject to the liabilities of that section of the Act but shall be subject to all other provisions of the Act. -
Eortc-1307-Bcg) (Big5-13) (Tesaro Pr-30-5010-C)
EORTC Avenue E. Mounierlaan 83/11 Brussel 1200 Bruxelles België – Belgique Tel: PPD e-mail: PPD www.eortc.org Intergroup Study (EORTC-1307-BCG) (BIG5-13) (TESARO PR-30-5010-C) (EudraCT number 2013-000684-85) (NCT01905592) (IND number # 117580) A phase III, randomized, open label, multicenter, controlled trial of niraparib versus physician’s choice in previously-treated, HER2 negative, germline BRCA mutation-positive breast cancer patients. Co-Lead: Breast International Group (BIG) EORTC Breast Cancer Group Study Coordinator: PPD (BIG) Study Co-Coordinators: PPD (BIG) PPD (EORTC) PPD (Tufts Medical Center) Protocol Date of PRC Amendment reference version approval/notification N° Classification Outline June 28, 2013 ---- ---- 1.0 July 22, 2013 ---- ---- 2.0 August 28, 2013 1 Scientific 3.0 April 24, 2014 3 Scientific 4.0 May 04, 2015 4 Scientific 5.0 November 04, 2015 5 Scientific 6.0 January 13, 2017 8 Scientific Version 6.0 / January 13, 2017 Copyright EORTC 2017 EORTC-1307-BCG / BIG5-13 / TESARO PR-30-5010-C Niraparib in BRCA germline mutated MBC Contact addresses Executive Committee: Defined in the related study charter Writing Committee: PPD (EORTC, Statistician) PPD (EORTC, Study Co-coordinator) PPD (Tufts Medical Center) PPD (BIG, Scientific Director) PPD (BIG, Ass. Scientific Director) PPD (EORTC, Statistician) PPD (EORTC, Clinical Research Physician) PPD (BIG, Study Coordinator) Steering Committee: Defined in the related study charter Version 6.0 2 / 102 January 13, 2017 EORTC-1307-BCG / BIG5-13 / TESARO PR-30-5010-C Niraparib