Press Release First Quarter 2021
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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. -
PEDIARIX Is a Vaccine
HIGHLIGHTS OF PRESCRIBING INFORMATION • If Guillain-Barré syndrome occurs within 6 weeks of receipt of a prior These highlights do not include all the information needed to use vaccine containing tetanus toxoid, the decision to give PEDIARIX should PEDIARIX safely and effectively. See full prescribing information for be based on potential benefits and risks. (5.2) PEDIARIX. • The tip caps of the prefilled syringes contain natural rubber latex which may cause allergic reactions. (5.3) PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis • Syncope (fainting) can occur in association with administration of Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus injectable vaccines, including PEDIARIX. Procedures should be in place Vaccine], Suspension for Intramuscular Injection to avoid falling injury and to restore cerebral perfusion following Initial U.S. Approval: 2002 syncope. (5.4) • If temperature ≥105°F, collapse or shock-like state, or persistent, ----------------------------- INDICATIONS AND USAGE ---------------------------- PEDIARIX is a vaccine indicated for active immunization against diphtheria, inconsolable crying lasting ≥3 hours have occurred within 48 hours after tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus, receipt of a pertussis-containing vaccine, or if seizures have occurred and poliomyelitis. PEDIARIX is approved for use as a 3-dose series in infants within 3 days after receipt of a pertussis-containing vaccine, the decision born of hepatitis B surface antigen (HBsAg)-negative mothers. PEDIARIX to give PEDIARIX should be based on potential benefits and risks. (5.5) may be given as early as 6 weeks of age through 6 years of age (prior to the • For children at higher risk for seizures, an antipyretic may be 7th birthday). -
Final Attendee List
Jennifer Abnet GlaxoSmithKline I GlaxoSmithKline I Jane Arboleda APRN Guardant I Molly Benson Sanjiv Agarwala MD Puma Biotechnology I Cancer Expert Now I Joe Arminger AbbVie I Seth Berkowitz LCSW, Manmeet Ahluwalia MD, CCLS MBA Patricia Armstrong The Leukemia & Lymphoma Miami Cancer Institute I Novartis I Society V Steve Albers Kim Arnold APRN CPNP Barry Berman MD, MS Alexion V CPHON Florida Cancer Specialists I Servier Pharmaceuticals I Maritza Alencar DNP, Tizano Bernard MBA, APRN, BMTCN Sheila Arrington MSN, Cancer Care Centers of Miami Cancer Institute V APRN, NP-C, AOCN Brevard I Puma Biotechnology I Carmen Allen MSIT Ana Mari Bernardini Pharmavoxx V Shannon Ashmon Novartis Oncology I Eisai, Inc I Luly Almeida Bernard Berry MBA Incyte Corporation I Sarah Ashton MS AstraZeneca Pharmaceuticals Guardant Health I I Talat Almukhtar MD Orlando Health Cancer Melissa Austin Jason Bever Institute I Cancer Care Centers of Oncopeptides I Brevard I Beatrice Alvarado Roberts Amy Bignon MD Garland Avera Doyle Caris Life Sciences I University of Florida I Jazz Pharmaceuticals I Nadeem Bilani MD Tadeu Ambros MD Francie Babcock Cleveland Clinic I FCS I AMAG Pharmaceuticals/Covis I Angela Bilik RN BSN Douglas Anderson AstraZeneca I Incyte Corporation I Craig Bailey Astra Zeneca I Jamie Bilsky BS Blesson Andrews Genentech V Genentech I Kevin Barr Daiichi Sankyo I Rohit Bishnoi MD Ollie Annum PharmD University of Florida I BHMCR I Leonard Bennett PharmD EMD Serono I Brady Blackman Susmitha Apuri MD MorphoSys I Florida Cancer Specialists I Michael Bennett As of 4-22-21 Kimberly Blandon RN MSN Rick Breitenstein Memorial Cancer Institute I Apellis Pharmaceuticals I Denise Capo Karyopharm Therapeutics I Taryn Boiteau GlaxoSmithKline I Amanda Bridges Florida Society of Clinical Heidi Caravetta Tracy Bonds RN, BSN, Oncology I Exelixis, Inc. -
The Everyday Lives of Recovering Heroin Users
The everyday lives of recovering heroin users Joanne Neale Sarah Nettleton Lucy Pickering The everyday lives of recovering heroin users The everyday lives of recovering heroin users Joanne Neale Sarah Nettleton Lucy Pickering Joanne Neale Professor of Public Health Faculty of Health & Life Sciences Oxford Brookes University Jack Straw’s Lane Marston Oxford OX3 0FL Email: [email protected] Sarah Nettleton Reader in Sociology Department of Sociology Wentworth College University of York Heslington York YO10 5DD Email: [email protected] Lucy Pickering Lecturer in Anthropology School of Social and Political Sciences University of Glasgow Adam Smith Building Glasgow G12 8RT Email: [email protected] Published by the RSA 8 John Adam Street London WC2N 6EZ +44 (0)20 7930 5115 Registered as a charity in England and Wales no. 212424 and in Scotland no. SCO 37784 Copyright © Joanne Neale 2012 The RSA is an enlightenment organisation devoted to finding innovative and practical solutions to today’s pressing social problems Cover photo: ‘Wings of butterfly,’ John Foxx. © Thinkstock Designed by Soapbox, www.soapbox.co.uk Printed and bound by CPI Antony Rowe www.theRSA.org Contents Acknowledgements 9 Foreword 10 Chapter 1: Setting the scene 14 Why read this book? 14 Why focus on recovery? 15 What is recovery? 15 A study of the everyday lives of recovering heroin users 17 Structure of the book 18 Chapter 2: Considering recovery 20 Introduction 20 Mapping services and support 20 Factors that can encourage and sustain recovery efforts -
(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. -
GLAXOSMITHKLINE LLC V. TEVA PHARMACEUTICALS USA, INC
Case: 18-1976 Document: 111 Page: 1 Filed: 10/02/2020 United States Court of Appeals for the Federal Circuit ______________________ GLAXOSMITHKLINE LLC, SMITHKLINE BEECHAM (CORK) LIMITED, Plaintiffs-Appellants v. TEVA PHARMACEUTICALS USA, INC., Defendant-Cross-Appellant ______________________ 2018-1976, 2018-2023 ______________________ Appeals from the United States District Court for the District of Delaware in No. 1:14-cv-00878-LPS-CJB, Chief Judge Leonard P. Stark. ______________________ Decided: October 2, 2020 ______________________ JUANITA ROSE BROOKS, Fish & Richardson, PC, San Diego, CA, argued for plaintiffs-appellants. Also represented by MICHAEL ARI AMON, CRAIG E. COUNTRYMAN, JONATHAN ELLIOT SINGER; ELIZABETH M. FLANAGAN, MICHAEL J. KANE, WILLIAM WOODFORD, Minneapolis, MN; DOUGLAS E. MCCANN, Wilmington, DE. WILLIAM M. JAY, Goodwin Procter LLP, Washington, DC, argued for defendant-cross-appellant. Also represented by JAIME ANN SANTOS; ELAINE BLAIS, J. Case: 18-1976 Document: 111 Page: 2 Filed: 10/02/2020 2 GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. ANTHONY DOWNS, ROBERT FREDERICKSON, III, CHRISTOPHER T. HOLDING, ALEXANDRA LU, LANA S. SHIFERMAN, DARYL L. WIESEN, Boston, MA; IRA J. LEVY, New York, NY. HANSJORG SAUER, Biotechnology Innovation Organization, Washington, DC, for amicus curiae Biotechnology Innovation Organization. Also represented by MELISSA A. BRAND; BRIAN PAUL BARRETT, Eli Lilly and Company, Indianapolis, IN. MICHAEL N. KENNEDY, Covington & Burling LLP, Washington, DC, for amicus curiae Pharmaceutical Research and Manufacturers of America. Also represented by STEVEN JOHN WINKELMAN; DAVID EVAN KORN, Pharmaceutical Research and Manufacturers Association of America, Washington, DC. ANDREW CURTIS NICHOLS, Winston & Strawn LLP, Washington, DC, for amicus curiae Association for Accessible Medicines. Also represented by GEORGE C. -
Declarations of Interest Thorax: First Published As 10.1136/Thoraxjnl-2016-209333.476 on 15 November 2016
Declarations of interest Thorax: first published as 10.1136/thoraxjnl-2016-209333.476 on 15 November 2016. Downloaded from KF Rabe reports financial for support for consultancy work P297 LUNG-FUNCTION PROFILE BEFORE AND AFTER THE from AstraZeneca, Chiesi, Novartis, MSD and GlaxoSmithKline, FIRST MODERATE TO SEVERE EXACERBATION DURING and grants from Altana, Novartis, AstraZeneca, MSD and THE WISDOM STUDY Nycomed. F Maltais reports financial support from Boehringer Ingelheim 10.1136/thoraxjnl-2016-209333.476 during the conduct of the study and, outside of the submitted work, financial support from Boehringer Ingelheim and GlaxoS- E Wouters, outside of the submitted work, reports personal fees mithKline for attendance at advisory boards, financial support from AstraZeneca, GlaxoSmithKline, Novartis, Takeda, Pfizer from Boehringer Ingelheim, GlaxoSmithKline, AstraZeneca and and Boehringer Ingelheim, and grants from AstraZeneca, GlaxoS- Novartis for speaking activities, and research support from Boeh- mithKline and Novartis. ringer Ingelheim, GlaxoSmithKline, AstraZeneca, Nycomed and H Magnussen received funding from Almirall, AstraZeneca, Novartis. Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Merck, Novar- tis, Takeda and Roche to conduct clinical studies, and has spoken at meetings and is a member of advisory boards for these and P295 EFFICACY AND SAFETY OF TIOTROPIUM/OLODATEROL other companies. IN PATIENTS WITH COPD BY ATS CATEGORY R Rodriguez-Roisin reports personal fees from AstraZeneca, Boehringer Ingelheim, Mylan, Pearl Therapeutics, Takeda, Teva 10.1136/thoraxjnl-2016-209333.474 and Ferrer, and grants and personal fees from Menarini and Almirall. F Maltais reports financial support from Boehringer Ingelheim K Tetzlaff and S Bell are employees of Boehringer Ingelheim during the conduct of the study and, outside of the submitted Pharma GmbH & Co. -
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. -
Other Statutory Disclosures Continued
Other statutory disclosures continued Strategic reportGroup companies Governance & remuneration Financial statements In accordance with Section 409 of the Companies Act 2006 a full list of subsidiaries, associates, joint ventures and joint arrangements, the country of incorporation and effective percentage of equity owned, as at 31 December 2015 are disclosed below. Unless otherwise stated the share capital disclosed comprises ordinary shares which are indirectly held by GlaxoSmithKline plc. All subsidiary companies are resident for tax purposes in their country of incorporation unless otherwise stated. Country of Effective % % Held by Name incorporation Ownership Security Class of Share Wholly owned subsidiaries 1506369 Alberta ULC Canada 100 Common 100 Action Potential Venture Capital Limited England & Wales 100 Ordinary 100 Adechsa GmbH Switzerland 100 Ordinary 100 Affymax Research Institute United States 100 Common 100 Alenfarma – Especialidades Farmaceuticas, Limitada (iv) Portugal 100 Ordinary Quota 100 Allen & Hanburys Limited (iv) England & Wales 100 Ordinary 100 Allen & Hanburys Pharmaceutical Nigeria Limited Nigeria 100 Ordinary 100 Allen Farmaceutica, S.A. Spain 100 Ordinary 100 Allen Pharmazeutika Gesellschaft m.b.H. Austria 100 Ordinary 100 Aners S.A (iv) Argentina 100 Non-endorsable Nominative Ordinary 100 Barrier Therapeutics, Inc. United States 100 Common 100 Beecham Group p l c England & Wales 100 20p Shares 'A'; 5p Shares B 100 Beecham Pharmaceuticals (Pte) Limited Singapore 100 Ordinary 100 Beecham Pharmaceuticals S.A (iv) (vi) Ecuador 100 Nominative 100 Beecham Portuguesa-Produtos Farmaceuticos e Quimicos, Lda Portugal 100 Ordinary Quota 100 Beecham S.A. (iv) Belgium 100 Ordinary 100 Biddle Sawyer Limited India 100 Equity 100 Biovesta Ilaçlari Ltd. Sti. Turkey 100 Nominative 100 Burroughs Wellcome & Co (Australia) Pty Limited (iv) (vi) Australia 100 Ordinary 100 Burroughs Wellcome & Co (Bangladesh) Limited Bangladesh 100 Ordinary 100 Burroughs Wellcome International Limited England & Wales 100 Ordinary 100 Caribbean Chemical Company, Ltd. -
In This Section
Strategic report In this section Chairman’s statement 2 CEO’s review 4 Business overview 6 The global context 8 Our business model 12 Our strategic priorities 14 How we performed 16 Risk management 18 Grow 20 Deliver 32 Simplify 44 Our financial architecture 48 Responsible business 50 Financial review 58 Strategic report Chairman’s statement Chairman’s statement To shareholders The value of the significant changes that have been made in recent years is evidenced in our performance this year “ Since Sir Andrew became It is clear from the following pages that Through the Audit & Risk Committee, we the Group made good progress against oversee the issues and challenges faced by CEO, the company has its strategy in 2013. management, and encourage the creation of an environment in which GSK can achieve The Board believes the business is seeing returned £30 billion its strategic ambitions in a responsible and the benefits of the significant changes the sustainable manner. to shareholders.” management team has driven over recent years to deliver sustainable growth, reduce risk and I have no doubt that commercial success is enhance returns to shareholders. directly linked to operating in a responsible way and which meets the changing expectations of The notably strong performance from the society. In this respect, the company continues R&D organisation in 2013 – with six major to adopt industry-leading positions on a range new product approvals in areas including of issues. respiratory disease, HIV and cancer – is critical to the longer-term prospects of the The announcement of plans during 2013 to Group. -
Glaxosmithkline Plc Annual Report for the Year Ended 31St December 2000
GlaxoSmithKline 01 GlaxoSmithKline plc Annual Report for the year ended 31st December 2000 Contents Report of the Directors 02 Financial summary 03 Joint statement by the Chairman and the Chief Executive Officer 05 Description of business 29 Corporate governance 37 Remuneration report 47 Operating and financial review and prospects 69 Financial statements 70 Directors’ statements of responsibility 71 Report by the auditors 72 Consolidated statement of profit and loss 72 Consolidated statement of total recognised gains and losses 74 Consolidated statement of cash flow 76 Consolidated balance sheet 76 Reconciliation of movements in equity shareholders’ funds 77 Company balance sheet 78 Notes to the financial statements 136 Group companies 142 Principal financial statements in US$ 144 Financial record 153 Investor information 154 Shareholder return 156 Taxation information for shareholders 157 Shareholder information 158 Share capital 160 Cross reference to Form 20-F 162 Glossary of terms The Annual Report was approved by the Board 163 Index of Directors on 22nd March 2001 and published on 12th April 2001. Contact details 02 GlaxoSmithKline Financial summary 2000 1999 Increase Business performance £m £m CER % £ % Sales 18,079 16,164 9 12 Trading profit 5,026 4,378 12 15 Profit before taxation 5,327 4,708 11 13 Earnings/Net income 3,697 3,222 13 15 Earnings per Ordinary Share 61.0p 52.7p 14 16 Total results Profit before taxation 6,029 4,236 Earnings/Net income 4,154 2,859 Earnings per Ordinary Share 68.5p 46.7p Business performance: results exclude merger items and restructuring costs; 1999 sales and trading profit exclude the Healthcare Services businesses which were disposed of in 1999. -
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