DOCSLIB.ORG

Public Availability of Pharma Policies on Their Role In

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Public Availability of Pharma Policies on Their Role In BDP45896f_BartlettPstr:BDP45896f_BartlettPstr 3/4/09 16:14 Page 1 PUBLIC AVAILABILITY OF PHARMA POLICIES ON THEIR ROLE IN PEER-REVIEWED PUBLICATIONS Sarah Bartlett, Andrew Berrie, Hilary Davidson, Alice Choi Complete Medical Communications and Complete Medical Group, Macclesfield, UK ⅷ Figure 1 shows the relative level of detail that each of the four companies provide on key ⅷ None of the four companies guarantee publication of all of their trial results in peer- ABSTRACT RESULTS aspects of publication policy and ethics. The two aspects of publication policy covered in detail reviewed journals. Table 3. Recognition of the role of professional medical writers. by all four of the companies were authorship and acknowledgments. All other aspects were Background: Cases of inappropriate publication practice and data disclosure have been highlighted in the ⅷ GlaxoSmithKline, Merck & Co, and Pfizer state that they reserve the right to review proposed Company Acknowledgment required Comments ⅷ Of the 20 companies considered within this analysis, only two (Daiichi Sankyo and Johnson & covered in varying degrees. past. Some pharmaceutical companies have developed statements/policies on their involvement in the manuscripts prior to submission; Merck & Co and Pfizer also state that they reserve the right Johnson) do not appear to have a publically available policy on the registration of clinical trials ߜ dissemination of company data in publications. Many such policies remain internal documents that are AstraZeneca and the disclosure of clinical trial results, nor on journal publication of company data (Table 1). Definition of ‘publication’, types of studies covered by policy, and the role to review proposed congress abstracts and associated presentations. GlaxoSmithKline and shared with investigators/authors and medical writers/agencies, but are not publically available. GlaxoSmithKline ߜ Professional medical writers may be of the company in publication Pfizer state that they do not suppress or veto submission of manuscripts. Objective: The objective of this survey was to establish which pharmaceutical companies had publication authors if contribution to manuscript meets policies available to the public and compare the content of these policies. ⅷ The definition of ‘publication’ and the types of studies published are provided in Table 2. ICMJE criteria Table 1. Public availability of policies on clinical trial registration and results posting and on Access to data Methods: The websites of 20 pharmaceutical companies were accessed to obtain relevant policies and publication policy for 20 pharmaceutical companies. Merck ߜ ⅷ these policies reviewed to assess similarities and differences. The four companies make data accessible to authors/investigators: Table 2. Defining ‘publication’ in policies and types of studies covered by the policies. Pfizer ߜ Professional medical writers may be Protocol registration Publication Protocol registration Publication Results: Most companies only mention their position on publications very briefly in the context of clinical trial – AstraZeneca: final protocol, statistical analysis plan, statistical tables, figures, and reports authors if contribution to manuscript meets registration and results disclosure. Merck & Co, GlaxoSmithKline, Pfizer, and AstraZeneca provide the most and results posting policy and results posting policy Company Description of publication Types of studies needed to prepare the publication ICMJE criteria comprehensive statements on publications in scientific journals. All four policies outline the companies’ ؂Pfizer ߜߜAbbott Laboratories ߜ authorship criteria and state professional medical writing support should be acknowledged. Other aspects AstraZeneca ‘publication in biomedical journals’ ‘all scientific, technical and medical – GlaxoSmithKline: summary of the overall trial results and if necessary, relevant reports, ؂GlaxoSmithKline ߜߜBristol-Myers Squibb ߜ covered to greater/lesser extents by at least one of the policies include the role of the company in publications originated or sponsored by figures, or tables; the complete study database can be reviewed by request at a GSK site ؂ߜ ؂manuscript development/review, protection of intellectual property, and author access to data. ߜ Sanofi-aventis Amgen AstraZeneca’ or other mutually agreeable location ؂Schering-Plough ߜ؂Conclusions: The majority of major pharmaceutical companies do not publish their publication policies on Novartis ߜ – : on request, review of the complete study database is permitted at the their corporate websites. Companies should be encouraged to consider making their policies publically GlaxoSmithKline ‘publish the results...in scientific ‘GSK-sponsored clinical trials that are Merck & Co CONCLUSIONS ؂Takeda ߜ؂Roche ߜ and medical journals and in relevant for patient care irrespective of company facility available, as this may help with transparency and improve reputational issues within this field. ● Although most of the surveyed major pharmaceutical companies have made policies on conference abstracts and whether the results are positive or ؂AstraZeneca ߜߜBayer ߜ – Pfizer: statistical tables, figures, and reports for the study at a designated Pfizer facility or clinical trial registration and data disclosure publically available, the majority do not proceedings’ negative for GSK prescription medicines ؂Merck & Co ߜߜBoehringer Ingelheim ߜ other mutually agreeable location. display detailed policies on their role in publications on their corporate websites. ’and vaccines ؂Astellas ߜ؂؂ Johnson & Johnson ⅷ AstraZeneca and Merck & Co policies also specifically state that they will provide the study ● Where publically available policies exist, there was agreement that: Merck ‘peer-reviewed papers; abstracts, ‘clinical trials sponsored and monitored ؂Novo Nordisk ߜ؂Eli Lilly ߜ INTRODUCTION protocol to the journal should it be requested. posters or presentations at a by Merck – studies in which we collect – although companies will post study results of clinical trials on a publically accessible ؂؂ Daiichi Sankyo؂Wyeth ߜ scientific meeting; or other and analyze data, including observational website, they cannot guarantee publication in a peer-reviewed journal ⅷ The medical and lay press have reported a number of instances where pharmaceutical Protecting intellectual property communication of study results studies in which medically important – authorship should be in accordance with ICMJE and the contributions of professional companies have not fully disclosed clinical trial data related to marketed products. Policy and such as posting on the internet’ results warrant publication’ ⅷ AstraZeneca, GlaxoSmithKline, and Pfizer all make statements regarding the protection of their ⅷ Fourteen companies posted brief statements describing their policy on registration of studies medical writers should be acknowledged law have been introduced to provide a greater degree of clarity regarding the trials conducted intellectual property: by pharmaceutical companies and the data resulting from those trials: and public disclosure of results.3-16 Pfizer ‘scientific articles, posters, ‘Pfizer-sponsored studies conducted in – authors/investigators should be given access to the original data abstracts, and in online results patients or which have scientific or – AstraZeneca: ‘In order to protect intellectual property effectively, any collaboration between – In 2004, the International Committee of Medical Journal Editors (ICMJE) announced that ⅷ AstraZeneca, GlaxoSmithKline, Merck & Co, and Pfizer all provide comprehensive information on – pharma companies have a role in reviewing proposed publications and in protecting databases’ medical importance’ AstraZeneca and a third party will be subject to a formal agreement that will address member journals would require clinical trial registration in a public trials registry as a the companies’ positions regarding the publication of company data in peer-reviewed publications, intellectual property in a way that does not jeopardize the timeliness of the publication. 1 ownership and access to data.’ condition of consideration for publication. 17-21 as well as policies on registration of studies and public disclosure of results. ● Companies should be encouraged to consider making their policies on the publication of – In 2007, Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA; – GlaxoSmithKline: ‘On an exceptional basis, although not in line with WHO and ICMJE company product data available publically, as this may help with transparency and Public Law 110-85) mandated reporting of results for Phase II-IV trials of all US Food and requirements that all data elements should be disclosed at the outset of our trials, GSK improve reputational issues within the field. Drug Administration (FDA)-approved products and those that will be submitted to the FDA for Figure 1. Level of detail on different aspects of publication policy. may delay registration of certain data elements (compound, name, outcome measures, marketing approval.2 and/or the official title) relating to ongoing Phase I and Phase II trials. This is because early AstraZeneca GlaxoSmithKline Merck & Co Pfizer ⅷ Peer-reviewed publication is considered by many to be the most complete form of data High disclosure of compound names and trial outcome measures could, in some circumstances, REFERENCES disclosure, and some pharmaceutical companies have developed policies regarding their prevent patentability or negatively
Load more

Recommended publications
  • In the United States District Court for the District Of
    IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE FOREST LABORATORIES, LLC and ) FOREST LABORATORIES ) HOLDINGS, LTD., ) ) Plaintiffs, ) ) v. ) Civ.No.14-1119-SLR ) SIGMAPHARM LABORATORIES, LLC, ) et al., ) ) Defendants. ) Jack B. Blumenfeld, Esquire and Maryellen Noreika, Esquire of Morris, Nichols, Arsht & Tunnell LLP, Wilmington, Delaware. Counsel for Plaintiffs. Of Counsel: Howard W. Levine, Esquire, Sanya Sukduang, Esquire, Jonathan R. Davies, Esquire, Courtney B. Gasp, Esquire, and Charles E. Lipsey, Esquire of Finnegan, Henderson, Farabow, Garrett & Dunner LLP. John C. Phillips, Esquire, David A. Bilson, Esquire and Megan C. Haney of Phillips, Goldman, Mclaughlin & Hall, P.A., Wilmington, Delaware. Counsel for Defendant Sigmapharm Laboratories, LLC. Of Counsel: Anthony G. Simon, Esquire, Anthony R. Friedman, Esquire, Benjamin R. Askew, Esquire, and Michael P. Kella, Esquire of The Simon Law Firm, P.C. Karen Elizabeth Keller, Esquire and Jeffrey Thomas Castellano, Esquire of Shaw Keller, LLP, Wilmington, Delaware. Counsel for Defendants Hikma Pharmaceuticals LLC, Hikma Pharmaceuticals PLC, and West-Ward Pharmaceutical Corp. Of Counsel: lmron T. Aly, Esquire, Joel M. Wallace, Esquire, and Helen H. Ji, Esquire of Schiff Hardin LLP. Richard D. Kirk, Esquire, Stephen B. Brauerman, Esquire and Sara E. Bussiere, Esquire of Bayard, P.A., Wilmington, Delaware. Counsel for Defendant Breckenridge Pharmaceutical, Inc. Of Counsel: Beth D. Jacob, Esquire, Clifford Katz, Esquire, and Malavika A. Rao, Esquire of Kelley, Drye & Warren LLP. Karen Pascale, Esquire and Pilar G. Kraman, Esquire of Young, Conaway, Stargatt & Taylor, LLP, Wilmington, Delaware. Counsel for Defendants Alembic Pharmaceuticals Ltd., Alembic Global Holding SA and Alembic Pharmaceuticals, Inc. Of Counsel: Steven J. Lee, Esquire, Michael K.
    [Show full text]
  • Preclinical Development & IND Filing: Nuts, Bolts, Best Practices
    “Preclinical Development & IND Filing: Nuts, Bolts, Best Practices and Regulatory Aspects.” Speakers: Amit Kalgutkar (Pfizer), Chandra Prakash (Agios), Sanjeev Thohan (Novartis), Li- Chun Wang (Takeda), Wei Yin (Biogen) Organizers: Sanjeev Thohan and Chandra Prakash Date: 6/29/2017 Time: 8:30 am – 5.00 pm Location: Boston/Cambridge Area: Marriott Kendall Square, 50 Broadway, Cambridge MA 02142 Fees: $175 - Regular (before June 1st, 2017), $225 - Regular (after June 1st, 2017); $125 - Unemployed & Academic; $2000 - Major Sponsorship; $475 - Vendor Show Registration: www.PBSS.org Workshop Description: An investigational new drug application (IND) is an important milestone that marks the entry of a molecule into clinical development. Knowing the objectives, expectations and processes of assembling an IND is a key to not only successful filing, but also a promising clinical development path forward. Often there are cases where too many of our “nice-to-have” studies crowd the package at the expense of critical study needs/issues. This can lead to significant delays in clinical developments with back-and-forth of Q&A sessions both internally and with regulatory agencies. As we have seen, the regulatory landscape is changing as rapidly as the industry innovates into new therapeutic modalities. Therefore, it is critical to keep up to date on regulatory requirements and the industry’s best practices in different aspects of the IND: non- clinical safety, PK, CMC, and clinical plans. In this workshop, our speakers who bring years of experience with multiple successful IND filings, will discuss systematically the preclinical studies required for small molecule IND’s as well as the nuts and bolts of putting together a high–quality IND package.
    [Show full text]
  • Assessment Report COVID-19 Vaccine Astrazeneca EMA/94907/2021
    29 January 2021 EMA/94907/2021 Committee for Medicinal Products for Human Use (CHMP) Assessment report COVID-19 Vaccine AstraZeneca Common name: COVID-19 Vaccine (ChAdOx1-S [recombinant]) Procedure No. EMEA/H/C/005675/0000 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, 2021. Reproduction is authorised provided the source is acknowledged. Table of contents 1. Background information on the procedure .............................................. 7 1.1. Submission of the dossier ..................................................................................... 7 1.2. Steps taken for the assessment of the product ........................................................ 9 2. Scientific discussion .............................................................................. 12 2.1. Problem statement ............................................................................................. 12 2.1.1. Disease or condition ........................................................................................ 12 2.1.2. Epidemiology and risk factors ........................................................................... 12 2.1.3. Aetiology and pathogenesis .............................................................................
    [Show full text]
  • Astrazeneca-Oxford Vaccine Approved for Use in the U.K
    P2JW366000-6-A00100-17FFFF5178F ****** THURSDAY,DECEMBER 31,2020~VOL. CCLXXVI NO.154 WSJ.com HHHH $4.00 DJIA 30409.56 À 73.89 0.2% NASDAQ 12870.00 À 0.2% STOXX 600 400.25 g 0.3% 10-YR. TREAS. À 3/32 , yield 0.926% OIL $48.40 À $0.40 GOLD $1,891.00 À $10.50 EURO $1.2300 YEN 103.21 Deadly Attack at Airport Targets New Yemen Government U.S. IPO What’s News Market Reaches Business&Finance Record nvestorspiled into IPOs Iat a record rate in 2020, with companies raising Total $167.2 billion via 454 of- ferings on U.S. exchanges this year through Dec. 24. Few see signs of letup Few expect the euphoria after companies raise to wear off soon. A1 more than $167 billion Detenteisending in the global fight over tech taxes, despite pandemic with Franceresuming collec- tion of itsdigital-services tax BY MAUREEN FARRELL and the U.S. poised to retali- atewith tariffs.Other coun- Defying expectations,inves- tries areset to join the fray. A1 S tors piled intoinitial public of- China finished 2020 PRES feringsatarecordrateiN with a 10th consecutive TED 2020, and few expect the eu- month of expansion in its CIA phoria to wear off soon. manufacturing sector. A7 SO Companies raised $167.2 AS TheEUand China agreed TENSIONS HIGH: People fled after an explosion Wednesday at the airport in Aden, Yemen, moments after members of the billion through 454 offerings in principle on an invest- country’s newly sworn-in cabinet arrived. At least 22 people were killed, but all the members of the cabinet were safe.
    [Show full text]
  • United States District Court for the District of Columbia
    Case 1:12-cv-00472-BAH Document 42 Filed 07/05/12 Page 1 of 49 UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA ASTRAZENECA PHARMACEUTICALS LP, Plaintiff, v. Civil Action No. 12-00472 (BAH) Judge Beryl A. Howell FOOD AND DRUG ADMINISTRATION, et al., Defendants. AMENDED MEMORANDUM OPINION Plaintiff AstraZeneca Pharmaceuticals LP (“AstraZeneca”) has manufactured the drug quetiapine fumarate (“quetiapine”) under the brand name Seroquel® (“Seroquel”) since 1997 without generic competition. AstraZeneca brought this lawsuit, which presents a question of statutory interpretation, against the Food and Drug Administration, Margaret A. Hamburg, M.D., Commissioner of Food and Drugs, and Kathleen Sebelius, Secretary of Health and Human Services (collectively, “the FDA”), to challenge the FDA’s approval, on March 27, 2012, of generic versions of Seroquel. See Complaint, ECF No. 1 (“Compl.”), ¶ 3. AstraZeneca believes that, under the plain language of 21 U.S.C. § 355(j)(5)(F)(iv), codifying Section 505(j)(5)(F)(iv) of the Federal Food, Drug, and Cosmetic Act (“FDCA”), it is entitled to total market exclusivity until December 2, 2012 for the safety information encapsulated in “Table 2,” which was approved for all Seroquel labels on December 2, 2009 and must be included on the labels of all generic versions of quetiapine. Based upon this belief, AstraZeneca seeks a judgment that the FDA’s recent approval of generic versions of quetiapine, while AstraZeneca retains exclusivity over Table 2, violated AstraZeneca’s exclusivity rights and was arbitrary, capricious, and contrary to law. 1 Case 1:12-cv-00472-BAH Document 42 Filed 07/05/12 Page 2 of 49 Pending before the Court are Cross-Motions for Summary Judgment filed by AstraZeneca, ECF No.
    [Show full text]
  • Cephalon Provigil
    r* jfS* 1 ll JS 44 {Rev. 07/16) SHEET The JS 44 civil cover sheet and the information contained herein neither replace nor supplement the filing and service of pleadings or other papers as required by law, except as provided by local rules of court. This form, approved by the Judicial Conference of the United States in September 1974, is required for the use of the Clerk of Court for the purpose ofinitiating the civil docket sheet. (SEE INSTRUCTIONS ON NEXT PAGE OF THIS FORM.) 1. (a) PLAINTIFFS DEFENDANTS State of New York, et al. Cephalon, Inc. et al. (b) County of Residence of First Listed Plaintiff County of Residence of First Listed Defendant (EXCEPT IN U.S. PLAINTIFF CASES) (IN U.S. PLAINTIFF CASES ONLY) NOTE: IN LAND CONDEMNATION CASES, USE THE LOCATION OF THE TRACT OF LAND INVOLVED. (c) Attorneys (Firm Name, Address, and Telephone Number) Attorneys (If Known) Office of the Attorney General, Commonwealth of Pennsylvania, 14® Floor Jay Lefkowitz, Kirkland & Ellis, 601 Lexington Avenue, New York, NY 10022 Strawberry Square, Harrisburg, PA 17120(717)787-4530 (212)446-4800 II. BASIS OF JURISDICTION (Placean "X" in One Box Only) III. CITIZENSHIP OF PRINCIPAL PARTIES (Placean "X" inOne Box for Plaintiff (For Diversify Cases Only) and One Box for Defendant) • 1 U.S. Government ^ 3 Federal Question PTF DEF PTF DEF Plaintiff (U.S. Government Not a Party) Citizen of This State Q 1 • 1 Incorporated or Principal Place Q 4 HI 4 of Business In This State l~l 2 U.S. Government • 4 Diversity Citizen of Another State • 2 Q 2 Incorporated and Principal Place G 5 Q 5 Defendant (Indicate Citizenship of Parties in Item III) of Business In Another State Citizen or Subject of a Q3 D 3 Foreign Nation D 6 06 Foreign Country IV.
    [Show full text]
  • Constituents & Weights
    2 FTSE Russell Publications 19 August 2021 FTSE 100 Indicative Index Weight Data as at Closing on 30 June 2021 Index weight Index weight Index weight Constituent Country Constituent Country Constituent Country (%) (%) (%) 3i Group 0.59 UNITED GlaxoSmithKline 3.7 UNITED RELX 1.88 UNITED KINGDOM KINGDOM KINGDOM Admiral Group 0.35 UNITED Glencore 1.97 UNITED Rentokil Initial 0.49 UNITED KINGDOM KINGDOM KINGDOM Anglo American 1.86 UNITED Halma 0.54 UNITED Rightmove 0.29 UNITED KINGDOM KINGDOM KINGDOM Antofagasta 0.26 UNITED Hargreaves Lansdown 0.32 UNITED Rio Tinto 3.41 UNITED KINGDOM KINGDOM KINGDOM Ashtead Group 1.26 UNITED Hikma Pharmaceuticals 0.22 UNITED Rolls-Royce Holdings 0.39 UNITED KINGDOM KINGDOM KINGDOM Associated British Foods 0.41 UNITED HSBC Hldgs 4.5 UNITED Royal Dutch Shell A 3.13 UNITED KINGDOM KINGDOM KINGDOM AstraZeneca 6.02 UNITED Imperial Brands 0.77 UNITED Royal Dutch Shell B 2.74 UNITED KINGDOM KINGDOM KINGDOM Auto Trader Group 0.32 UNITED Informa 0.4 UNITED Royal Mail 0.28 UNITED KINGDOM KINGDOM KINGDOM Avast 0.14 UNITED InterContinental Hotels Group 0.46 UNITED Sage Group 0.39 UNITED KINGDOM KINGDOM KINGDOM Aveva Group 0.23 UNITED Intermediate Capital Group 0.31 UNITED Sainsbury (J) 0.24 UNITED KINGDOM KINGDOM KINGDOM Aviva 0.84 UNITED International Consolidated Airlines 0.34 UNITED Schroders 0.21 UNITED KINGDOM Group KINGDOM KINGDOM B&M European Value Retail 0.27 UNITED Intertek Group 0.47 UNITED Scottish Mortgage Inv Tst 1 UNITED KINGDOM KINGDOM KINGDOM BAE Systems 0.89 UNITED ITV 0.25 UNITED Segro 0.69 UNITED KINGDOM
    [Show full text]
  • Global Focus – Economic Outlook Q2-2021
    Global Research Global Focus – Economic Outlook Q2-2021 Global growth – An uneven race research.sc.com Standard Chartered Global Research is available across all iOS and Android devices. Our intuitive, accessible and customisable apps* allow you to receive our reports, forecasts, audio-visual presentations and interactive data visualisation tools on-the-go. * Click the icons to download or search ‘Standard Chartered Global Research’ in the app store. If you are in scope for MiFID II and want to opt out of our Research services, please contact us. Issuer of Report Standard Chartered Bank Important disclosures and analyst certifications can be found in the Disclosures Appendix All rights reserved. Standard Chartered Bank 2021 https://research.sc.com Global Focus – Economic Outlook Q2-2021 Table of contents Global overview 3 Cameroon – Moving towards recovery 75 Global growth – An uneven race 4 Côte d’Ivoire – A series of unfortunate events 76 Where we differ from consensus 10 Ethiopia – A particularly difficult quarter ahead 77 Global charts 12 Gabon – The oil price reprieve 78 Ghana – The long reach of the COVID crisis 79 Geopolitical economics 14 Kenya – Third-wave woes 80 Biden’s democracy club 15 Mozambique – Delayed but not denied 81 Economies – Asia 20 Nigeria – Higher oil, faltering reform 82 Asia – Top charts 21 Senegal – Flaring tensions 83 Asia – Macro trackers 22 South Africa – Bracing for a third wave 84 Australia – Chugging along 24 Tanzania – Transition 86 Bangladesh – Turning around 26 Uganda – Oil to drive growth acceleration
    [Show full text]
  • FDA Listing of Authorized Generics As of July 1, 2021
    FDA Listing of Authorized Generics as of July 1, 2021 Note: This list of authorized generic drugs (AGs) was created from a manual review of FDA’s database of annual reports submitted to the FDA since January 1, 1999 by sponsors of new drug applications (NDAs). Because the annual reports seldom indicate the date an AG initially entered the market, the column headed “Date Authorized Generic Entered Market” reflects the period covered by the annual report in which the AG was first reported. Subsequent marketing dates by the same firm or other firms are not included in this listing. As noted, in many cases FDA does not have information on whether the AG is still marketed and, if not still marketed, the date marketing ceased. Although attempts have been made to ensure that this list is as accurate as possible, given the volume of d ata reviewed and the possibility of database limitations or errors, users of this list are cautioned to independently verify the information on the list. We welcome comments on and suggested changes (e.g., additions and deletions) to the list, but the list may include only information that is included in an annual report. Please send suggested changes to the list, along with any supporting documentation to: [email protected] A B C D E F G H I J K L M N O P Q R S T U V X Y Z NDA Applicant Date Authorized Generic Proprietary Name Dosage Form Strength Name Entered the Market 1 ACANYA Gel 1.2% / 2.5% Bausch Health 07/2018 Americas, Inc.
    [Show full text]
  • Vanguard FTSE 100 Index Unit Trust GBP Inc Inception Date: 08 November 2016
    Vanguard® Factsheet | 31 August 2021 Vanguard FTSE 100 Index Unit Trust GBP Inc Inception date: 08 November 2016 Total assets (million) £650 | Share class assets (million) £82 as at 31 August 2021 Minimum Trading initial Investment Index frequency investment* ISIN SEDOL Bloomberg Citi MexID SRRI‡ IA Sector structure ticker Domicile Settlement (cut-off) 1,000,000 GB00BD3RZ251 BD3RZ25 VAFTIGI NGLZ VRXXD 6 — UCITS UKXNUK United T+2 Daily (12:00 Kingdom London Time) Management Charges Ongoing Charges Figure† 0.06% †The Ongoing Charges Figure (OCF) covers administration, audit, depository, legal, registration and regulatory expenses incurred in respect of the Funds. When you invest with any fund manager, you pay a number of charges, starting with the Annual Management Charge (AMC) which covers the fund manager's costs of managing the fund. The AMC plus ongoing running costs and other operational expenses make up the fund's total 'ongoing charges figure'. Objectives and investment policy • The fund is a passive fund. • The Fund seeks to track the performance of the FTSE 100 Index (the “Index”). • The Index is a market-capitalisation weighted index representing the performance of the 100 largest companies traded on the London Stock Exchange that pass screening for size and liquidity. Market-capitalisation is the value of a company’s outstanding shares in the market and shows the size of a company. • The Fund attempts to: 1. Track the performance of the Index by investing in all constituent shares of the Index in the same proportion as the Index. Where not practicable to fully replicate, the Fund will use a sampling process.
    [Show full text]
  • COVID-19 Vaccine Safety Update for Vaxzevria
    14 July 2021 COVID-19 vaccine safety update VAXZEVRIA AstraZeneca AB The safety of Vaxzevria is continuously monitored and safety updates are regularly provided to the public. This document outlines the outcomes from the assessment of emerging worldwide safety data carried out by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) (see section 1). It also contains high-level information from the reporting of suspected adverse reactions, which PRAC takes into account in its assessments (see section 2). This safety update follows the update of 18 June 2021. Main outcomes from PRAC's latest safety assessment Vaccinated persons need to seek immediate medical attention if they develop weakness and paralysis in the extremities, possibly progressing to the chest and face, after vaccination with Vaxzevria, as these could be signs of Guillain-Barré syndrome. The product information will be updated. Vaxzevria is effective in preventing COVID-19. www.ema.europa.eu COVID-19 vaccine safety update VAXZEVRIA The safety updates are published regularly at COVID-19 vaccines: authorised. All published safety updates for Vaxzevria are available at Vaxzevria: safety updates. Since its marketing authorisation in the European Union (EU) on 29 January 2021 until 4 July 2021, more than 58.4 million doses of Vaxzevria have been administered in the EU/EEA1. More than 58.4 million doses administered in EEA 1. Updates on safety assessments for Vaxzevria Based on new safety data, including the latest Monthly Summary Safety Report (MSSR)2 from the marketing authorisation holder and data reported by patients and healthcare professionals to EudraVigilance (see section 2), PRAC assessed the following at its meeting held 5 to 8 July 2021: Guillain-Barré syndrome (GBS) PRAC assessed cases of Guillain-Barré syndrome (GBS) reported after vaccination with Vaxzevria.
    [Show full text]
  • Declarations of Interest Thorax: First Published As 10.1136/Thoraxjnl-2016-209333.467 on 15 November 2016
    Declarations of interest Thorax: first published as 10.1136/thoraxjnl-2016-209333.467 on 15 November 2016. Downloaded from P55 BENEFITS OF TIOTROPIUM/OLODATEROL ON B Make has received honoraria for participation in NOVELTY SYMPTOMS AND HEALTH-RELATED QUALITY OF LIFE IN planning meeting, and has received grant funding, participated in PATIENTS WITH MODERATE TO SEVERE COPD WITH advisory boards and provided non-branded talk for AstraZeneca. CHRONIC BRONCHITIS AND/OR EMPHYSEMA He has received honoraria for participation in medical advisory boards for Aerocrine, Boehringer-Ingelheim, CSL Bering, GlaxoS- 10.1136/thoraxjnl-2016-209333.467 mithKline, Forest, Novartis, Spiration, Theravance, and Suno- vion. He has participated in research studies funded by Boehringer-Ingelheim, GlaxoSmithKline, Pfizer, Forest, Sunovian. GT Ferguson, during the conduct of the study, reports grants, RJ Martin has received consulting fees from AstraZeneca, personal fees and non-financial support from Boehringer Ingel- Teva, Genentech, Boeringer Ingelheim, and PMD. His institution heim and, outside the submitted work, grants, personal fees and has received grants from NHLBI (AsthmaNet) and MedImmune. non-financial support from Boehringer Ingelheim, personal fees He has also received travel/accommodation/meeting expenses from GlaxoSmithKline, grants and personal fees from Novartis, from the Respiratory Effectiveness Group. AstraZeneca, Pearl Therapeutics and Sunovion, and grants from I Pavord has received speaker’s honoraria for speaking at Forest. sponsored meetings from Astra Zeneca, Boehringer Ingelheim, R Abrahams reports grants and personal fees from Boehringer Aerocrine, Almirall, Novartis, and GSK and a payment for organ- Ingelheim during the conduct of the study and, outside of this ising an educational event from AZ.
    [Show full text]