DOCSLIB.ORG

Declarations of Interest Thorax: First Published As 10.1136/Thoraxjnl-2016-209333.476 on 15 November 2016

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
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. KG. PMAC reports financial support in work, financial support from Boehringer Ingelheim and GlaxoS- the form of a grant from Boehringer Ingelheim to conduct the mithKline for attendance at advisory boards, financial support study and, outside of the submitted work, reports personal fees from Boehringer Ingelheim, GlaxoSmithKline, AstraZeneca and from GlaxoSmithKline, AstraZeneca, Takeda and Boehringer Novartis for speaking activities, and research support from Boeh- Ingelheim, and grants from GlaxoSmithKline and Takeda. ringer Ingelheim, GlaxoSmithKline, AstraZeneca, Nycomed and Novartis. E Pizzichini has nothing to disclose. L Grönke and F Voß are employees of Boehringer Ingelheim P298 TIOTROPIUM/OLODATEROL THERAPY PROVIDES Pharma GmbH & Co. KG. SYMPTOMATIC BENEFITS IRRESPECTIVE OF PRIOR E Derom, outside of the submitted work, reports financial MAINTENANCE TREATMENT: POST HOC ANALYSES OF support from Boehringer Ingelheim, Actelion, AstraZeneca and THE OTEMTO® STUDIES Cipla for consultancy work, financial support from Chiesi, Astra- Zeneca and CSL Behring for advisory board attendance, and 10.1136/thoraxjnl-2016-209333.477 research support from Boehringer Ingelheim and GlaxoSmithKline. R Abrahams reports grants and personal fees from Boehringer http://thorax.bmj.com/ Ingelheim during the conduct of the study and, outside of this work, grants and personal fees from GlaxoSmithKline and grants P296 EFFECT OF TIOTROPIUM/OLODATEROL THERAPY ON from AstraZeneca and Pearl Therapeutics. COPD EXACERBATIONS IN THE TONADO® STUDIES GT Ferguson, during the conduct of the study, reports grants, personal fees and non-financial support from Boehringer Ingel- 10.1136/thoraxjnl-2016-209333.475 heim and, outside the submitted work, grants, personal fees and non-financial support from Boehringer Ingelheim, personal fees from GlaxoSmithKline, grants and personal fees from Novartis, on October 1, 2021 by guest. Protected copyright. E Derom, outside of the submitted work, reports financial sup- AstraZeneca, Pearl Therapeutics and Sunovion, and grants from port from Boehringer Ingelheim, Actelion, AstraZeneca and Cipla Forest. for consultancy work, financial support from Chiesi, AstraZeneca L Bjermer reports no conflicts of interest. and CSL Behring for advisory board attendance, and research L Grönke and F Voß are employees of Boehringer Ingelheim support from Boehringer Ingelheim and GlaxoSmithKline. Pharma GmbH & Co. KG. M Fležar has received personal fees from Boehringer Ingel- D Singh reports other financial activities from Boehringer heim and institutional financial support from Novartis. Ingelheim during the conduct of the study and, outside of the L Grönke and F Voß are employees of Boehringer Ingelheim submitted work, grants and personal fees from Almirall, AstraZe- Pharma GmbH & Co. KG. neca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Glenmark, R Buhl reports financial support to his institution from Boeh- Johnson & Johnson, Merck, NAPP, Novartis, Pfizer, Takeda, ringer Ingelheim during the conduct of the study and, outside of Teva, Theravance and Verona, and personal fees from Genentech the submitted work, financial support from Boehringer Ingel- and SkyePharma. heim, AstraZeneca, Chiesi, Novartis, Teva, Roche and GlaxoS- mithKline for attendance at advisory boards and speaking activities, and research support to his institution from Boehringer Ingelheim, GlaxoSmithKline, Novartis and Roche. Thorax 2016;71(Suppl 3):A1–A288 A273.
Load more

Recommended publications
  • 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.
    [Show full text]
  • 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).
    [Show full text]
  • A Forum Report on Continuous Manufacturing for Biologics
    A Forum Report on Continuous Manufacturing for Biologics CMC Strategy Forum Jan 28, 2019 in Washington , DC Andrew Chang, Ph.D. Vice President, Quality and Regulatory Compliance, Novo Nordisk Quality Novo Nordisk A/S Agenda 1 Overview the Forum Program 2 Key Learnings: Small Molecules vs. Biologics 3 Panel Discussion Outcome Opportunities and Challenges Central Questions Raised for planning the Positive Regulatory Environment CMC Strategy Forum on Continuous Manufacturing for Biologics • What are the business opportunities for introducing continuous manufacturing for biologics? • What are current gaps and hurdles for implementing continuous manufacturing for biologics? • What levels of automation in biopharmaceuticals is needed for continuous manufacturing? • What novel analytical technologies are Dr. Rapti D. Madurawe, needed for continuous manufacturing? FDA/CDER/OPQ/OPF, 2019 DIA CMC Workshop • What can we leverage from our knowledge of small molecule continuous manufacturing to enable or accelerate continuous manufacturing for biologics? The Forum Overview (1) Morning Session (Co-Chairs: Lindsay Arnold, MedImmune and Min Zhu, Boehringer Ingelheim Biopharmaceuticals ) • Industry Perspectives • Small molecule experience - Thomas Garcia, Pfizer, Inc. • Continuous biomanufacturing: experience and emerging opportunities - Erik Fouts, BioMarin Pharmaceutical Inc. • Analytical Technologies • Control of continuous bioprocess (PAT) - Mark Brower, Merck & Co., Inc., • Panel Discussion • Participants will discuss pre-identified issues and brainstorm
    [Show full text]
  • 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.
    [Show full text]
  • A Phase Ib/II Study of Xentuzumab, an IGF-Neutralising Antibody
    Schmid et al. Breast Cancer Research (2021) 23:8 https://doi.org/10.1186/s13058-020-01382-8 RESEARCH ARTICLE Open Access A phase Ib/II study of xentuzumab, an IGF-neutralising antibody, combined with exemestane and everolimus in hormone receptor-positive, HER2-negative locally advanced/metastatic breast cancer Peter Schmid1*, Marie-Paule Sablin2, Jonas Bergh3, Seock-Ah Im4, Yen-Shen Lu5, Noelia Martínez6, Patrick Neven7, Keun Seok Lee8, Serafín Morales9, J. Alejandro Pérez-Fidalgo10, Douglas Adamson11, Anthony Gonçalves12, Aleix Prat13, Guy Jerusalem14, Laura Schlieker15, Rosa-Maria Espadero16, Thomas Bogenrieder17,18, Dennis Chin-Lun Huang19,20, John Crown21† and Javier Cortés22,23† Abstract Background: Xentuzumab—a humanised IgG1 monoclonal antibody—binds IGF-1 and IGF-2, inhibiting their growth-promoting signalling and suppressing AKT activation by everolimus. This phase Ib/II exploratory trial evaluated xentuzumab plus everolimus and exemestane in hormone receptor-positive, locally advanced and/or metastatic breast cancer (LA/MBC). Methods: Patients with hormone receptor-positive/HER2-negative LA/MBC resistant to non-steroidal aromatase inhibitors were enrolled. Maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of xentuzumab/ everolimus/exemestane were determined in phase I (single-arm, dose-escalation). In phase II (open-label), patients were randomised 1:1 to the RP2D of xentuzumab/everolimus/exemestane or everolimus/exemestane alone. Randomisation was stratified by the presence of visceral metastases. Primary endpoint was progression-free survival (PFS). (Continued on next page) * Correspondence: [email protected] †John Crown and Javier Cortés contributed equally to this work. 1Centre for Experimental Cancer Medicine, Barts Cancer Institute, Queen Mary University of London, London, UK Full list of author information is available at the end of the article © The Author(s).
    [Show full text]
  • 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.
    [Show full text]
  • 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.
    [Show full text]
  • Johnson & Johnson and Pfizer Inc., Analysis of Agreement Containing
    ANALYSIS OF AGREEMENT CONTAINING CONSENT ORDERS TO AID PUBLIC COMMENT In the Matter of Johnson & Johnson and Pfizer Inc. File No. 061-0220, Docket No. C-4180 I. Introduction The Federal Trade Commission (“Commission”) has accepted, subject to final approval, an Agreement Containing Consent Orders (“Consent Agreement”) from Johnson & Johnson (“J&J”) and Pfizer Inc. (“Pfizer”), which is designed to remedy the anticompetitive effects that would otherwise result from J&J’s proposed acquisition of Pfizer Consumer Healthcare. Under the terms of the proposed Consent Agreement, the parties will be required to divest: (1) Pfizer’s Zantac® H-2 blocker business; (2) Pfizer’s Cortizone® hydrocortisone anti-itch business; (3) Pfizer’s Unisom® nighttime sleep-aid business; and (4) J&J’s Balmex® diaper rash treatment business. The proposed Consent Agreement has been placed on the public record for thirty (30) days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After thirty (30) days, the Commission will again review the proposed Consent Agreement and will decide whether it should withdraw from the proposed Consent Agreement, modify it, or make final the Decision and Order (“Order”). Pursuant to a Stock and Asset Purchase Agreement dated June 25, 2006, J&J proposes to acquire certain voting securities and assets comprising Pfizer’s Consumer Healthcare business in a transaction valued at approximately $16.6 billion (“Proposed Acquisition”). The Commission’s complaint alleges that the Proposed Acquisition, if consummated, would violate Section 7 of the Clayton Act, as amended, 15 U.S.C.
    [Show full text]
  • Producing Value
    Boehringer Ingelheim BioXcellence™ Producing Value Global Contract Manufacturing Excellence Your World Class Contract Manufacturer Boehringer Ingelheim BioXcellence™ Producing Value Boehringer Ingelheim BioXcellence™ Boehringer Ingelheim BioXcellence™ is a leading contract manufacturer with more than 35 years of experience – and 19 biopharmaceutical products brought to market. • We provide tailor-made solutions – where you need us, when you need us • Our transparent, modular approach -regardless of your project’s stage, scope or scales- makes outsourcing easy • Our experience, reliability and flexibility help you to better focus on your strategic priorities • As a family-owned business, we pride ourselves on stability and committed long-term relationships www.bioxcellence.com 3 Boehringer Ingelheim BioXcellence™ Our Mission: Producing Value 4 BioXcellence | Producing Value Producing Value We provide smart manufacturing solutions to the industry, empowering our customers to successfully navigate the challenges of the biopharmaceutical market. Boehringer Ingelheim has a long history more than 200,000 liters with flexible scales in the field of biotechnology, having been in between 400 and 12,000 liters. For products the industry for more than 35 years and in derived from microbial fermentation technol- contract manufacturing since 1995. During ogy more than 12,000 liters of commercial that time we have helped our customers to capacity with flexible scales from 200 liters to bring 19 molecules to the market. This has 4,500 liters are installed at our site in Vienna, earned us a reputation as one of the most Austria. experienced and reliable contract manu- facturing organizations (CMO) in the world. With more than 2,300 employees in bio- Boehringer Ingelheim Contract Manufacturing pharma development, quality and manu- has now evolved into Boehringer Ingelheim facturing Boehringer Ingelheim BioXcellence BioXcellence™ - your dedicated contract is your sustainable, committed contract manufacturer.
    [Show full text]
  • PRESCRIBING INFORMATION ------WARNINGS and PRECAUTIONS------These Highlights Do Not Include All the Information Needed to Use JARDIANCE Safely and Effectively
    HIGHLIGHTS OF PRESCRIBING INFORMATION -----------------------WARNINGS AND PRECAUTIONS------------------------ These highlights do not include all the information needed to use JARDIANCE safely and effectively. See full prescribing information for Ketoacidosis: Assess patients who present with signs and symptoms of JARDIANCE. metabolic acidosis for ketoacidosis, regardless of blood glucose level. If suspected, discontinue JARDIANCE, evaluate and treat promptly. JARDIANCE® (empagliflozin tablets), for oral use Before initiating JARDIANCE, consider risk factors for ketoacidosis. Initial U.S. Approval: 2014 Patients on JARDIANCE may require monitoring and temporary discontinuation of therapy in clinical situations known to predispose to ---------------------------RECENT MAJOR CHANGES--------------------------- ketoacidosis. (5.1) Volume Depletion: Before initiating JARDIANCE, assess volume status Indications and Usage (1) 8/2021 and renal function in patients with impaired renal function, elderly Dosage and Administration (2.1) 6/2021 patients, or patients on loop diuretics. Monitor for signs and symptoms Dosage and Administration (2.2) 8/2021 during therapy. (5.2, 6.1) Dosage and Administration (2.3) – Removed 8/2021 Urosepsis and Pyelonephritis: Evaluate patients for signs and symptoms Contraindications (4) 6/2021 of urinary tract infections and treat promptly, if indicated (5.3) Warnings and Precautions (5.1, 5.2) 6/2021 Hypoglycemia: Consider lowering the dose of insulin secretagogue or Warnings and Precautions (5.3, 5.5) 8/2021 insulin to reduce the risk of hypoglycemia when initiating JARDIANCE Warnings and Precautions (5.9) – Removed 6/2021 (5.4) ----------------------------INDICATIONS AND USAGE--------------------------- Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene): Serious, JARDIANCE is a sodium-glucose co-transporter 2 (SGLT2) inhibitor life-threatening cases have occurred in both females and males.
    [Show full text]
  • 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.
    [Show full text]
  • ESG Performance Summary 2020 About This Report
    ESG Performance Summary 2020 About this report In this report: Trust is one of our three long-term priorities Our commitments 1 and is essential to how we achieve our purpose, Data summary 2 drive long-term growth and add value for society SASB index 17 United Nations Global Compact and our shareholders. Communication on Progress 20 Global Reporting Initiative We have 13 commitments that support About our reporting guidelines 25 our Trust priority and drive progress in the This document provides a comprehensive Assurance report 30 key areas where we can make a significant summary of environmental, social and Public policies available online 32 impact, and ensure that we are running our governance (ESG) data from across our business in a responsible way. business. This complements our wider reporting on responsible business in our These commitments seek to address Annual Report where we report progress In our Annual Report: the most material topics relevant to on our 13 Trust commitments and in the Stakeholder engagement our stakeholders and to our business, responsible business pages of gsk.com. Progress against our Trust commitments and are designed to help us respond Climate change resilience (TCFD) to challenges and opportunities within our industry and society more broadly. Other online reporting: They contribute to many of the UN Materiality assessment Sustainable Development Goals, and Human rights as a science-led, global healthcare Sustainable Development Goals company, our biggest contribution is Political advocacy towards Goal 3: ensure healthy lives Patient group funding and promote well-being for all at all ages. Trade association memberships Charitable grant contributions Cautionary statement Criteria for working with Public Policy Groups See page 32 of this document for the cautionary statement regarding forward-looking statements.
    [Show full text]