IWG

argenx Announces Approval of VYVGART (efgartigimod alfa) in Japan for Adults with Primary Immune Thrombocytopenia

Retrieved on: 
Tuesday, March 26, 2024
Diagnosis, Blood pressure, Efgartigimod alfa, System, Urination, Urinary tract infection, MHLW, Chest pain, Rituximab, Allergy, Disease, Infection, Risk, Headache, Patient, Sore throat, IWG, History, ITP, Chills, Quality of life, Cough, Euronext, Rash, Respiratory tract infection, Splenectomy, Medicine, Skin, Fever, Antibody, Wheeze, Back pain, Shivering, Safety, Pain, Fatigue, Phlegm, Swelling, Food, Autoimmune disease, Nursing

“argenx is on a mission to deliver transformative medicines for people living with severe autoimmune disease,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx.

Key Points: 
  • “argenx is on a mission to deliver transformative medicines for people living with severe autoimmune disease,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx.
  • By reducing circulating autoantibodies, VYVGART is uniquely designed to serve as a precision intervention that targets the underlying disease biology of ITP.
  • ADVANCE successfully met its primary endpoint, demonstrating that a higher proportion of chronic ITP patients receiving VYVGART achieved a sustained platelet count response compared to placebo.
  • Do not use VYVGART if you have a serious allergy to efgartigimod alfa or any of the other ingredients in VYVGART.

Hasbro Announces Changes to Board of Directors

Retrieved on: 
Monday, March 25, 2024
Professional Services, Family, General Entertainment, Consumer, Other Retail, Entertainment, Other Manufacturing, Toys, Business, Manufacturing, Retail, Other Professional Services, Parenting, Children, Other Entertainment, Online Retail, Baby, Maternity, Nexon, Emeritus, Primrose Schools, Growth, Zynga Poker, Darkness, Take-Two Interactive, IWG, DNA, Electronic Arts, Magic, Puzzle, CSR Racing, Investment, Retirement, Friends, IWG plc, Captain, Annual general meeting, Corporation, Management

“We are thrilled to have Frank, Darin, and Owen join our accomplished and diverse Board of Directors,” said Rich Stoddart, Chair of Hasbro’s Board of Directors.

Key Points: 
  • “We are thrilled to have Frank, Darin, and Owen join our accomplished and diverse Board of Directors,” said Rich Stoddart, Chair of Hasbro’s Board of Directors.
  • Each of them will add tremendous value and unique perspective to our Board.
  • Alan will continue to be actively engaged with Hasbro helping to guide the company’s charitable efforts, in addition to his many other philanthropic pursuits.
  • That won’t change and I’m excited to support Hasbro in my next chapter.”

Union procedure on the preparation, conduct and reporting of EU pharmacovigilance inspections

Retrieved on: 
Wednesday, April 3, 2024
Community, Reproduction, Appendix, European Medicines Agency, Patient, Parliament, MAH, Council, Member state, European, NCA, GxP, Legislation, Communication, Comment, Classification, Partnership, Risk, Committee, PSMF, Safety, Calendar, CHMP, State, Documentation, Public, Directive 2001/83/EC, IWG, GVP, Commission, CAPA, Guideline, IO, Computer, PRAC, European Parliament, Registry, Record, Peer review, Language, Collection, Inspection

Union procedure on the preparation, conduct and

Key Points: 
    • Union procedure on the preparation, conduct and
      reporting of EU pharmacovigilance inspections
      Table of contents
      1.
    • Record management and archiving ....................................................................... 12

      References ................................................................................................ 12
      Appendix 1 ?Pharmacovigilance inspection report .................................... 13
      Appendix 2- Inspection overview (IO) ...................................................... 14
      Appendix 3- Pharmacovigilance inspection outcome sharing .................... 15
      Appendix 4- Classification of inspection findings....................................... 16

      Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
      inspections
      EMA/INS/PhV/192230/2014

      Page 2/16

      1.

    • Guidelines on the interpretation of legislative pharmacovigilance
      requirements are published in the adopted good pharmacovigilance practices (GVPs) Module III ?
      pharmacovigilance inspections.
    • Preparation of a risk-based programme for pharmacovigilance inspections is presented in the Union
      procedure on the coordination of EU pharmacovigilance inspections.
    • Scope
      This procedure constitutes a guideline in preparing, conducting and reporting national competent
      authority (NCA) pharmacovigilance inspections and outlines the steps taken of the Committee for
      Medicinal Products for Human Use (CHMP) requested pharmacovigilance inspections.
    • Those are covered under the Union procedure on the
      management of pharmacovigilance inspection findings which may impact the robustness of the benefitrisk profile of the concerned medicinal products.
    • Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
      inspections
      EMA/INS/PhV/192230/2014

      Page 3/16

      3.

    • Preparation
      Preparation encompasses those activities undertaken after the selection of an MAH, or third party, for
      a pharmacovigilance inspection and prior to inspection conduct.
    • For the selection of involved
      parties for CHMP requested inspections, refer to the Union procedure on the coordination of EU
      pharmacovigilance inspections.
    • Announcement communications could include, for example, the

      Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
      inspections
      EMA/INS/PhV/192230/2014

      Page 4/16

      name of the inspector(s), MAH, the objectives and nature of the inspection (i.e.

    • Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
      inspections
      EMA/INS/PhV/192230/2014

      Page 5/16

      ?

      Feedback from other competent authority functions, in particular pharmacovigilance assessors.

    • Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
      inspections
      EMA/INS/PhV/192230/2014

      Page 6/16

      ?

      If teleconference(s) are planned during the inspection with experts, assessors, MAH personnel
      located off site etc.

    • ?

      Union procedure on the management of pharmacovigilance inspection findings which may impact
      the robustness of the benefit-risk profile of the concerned medicinal products.

    • Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
      inspections
      EMA/INS/PhV/192230/2014

      Page 12/16

      Appendix 1 ?Pharmacovigilance inspection report
      Click here for the template.

    • Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
      inspections
      EMA/INS/PhV/192230/2014

      Page 13/16

      Appendix 2- Inspection overview (IO)
      Click here for the template.

    • Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
      inspections
      EMA/INS/PhV/192230/2014

      Page 14/16

      Appendix 3- Pharmacovigilance inspection outcome sharing
      Click here for the template.

    • Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
      inspections
      EMA/INS/PhV/192230/2014

      Page 16/16

EQS-News: IWG Finance AG Invests Millions in Telemedicine Breakthrough: Doctors365

Retrieved on: 
Tuesday, January 30, 2024
App Store (iOS/iPadOS), Patient, IWG, Google Play, News, Nursing

IWG Finance AG Invests Millions in Telemedicine Breakthrough: Doctors365

Key Points: 
  • IWG Finance AG Invests Millions in Telemedicine Breakthrough: Doctors365
    The issuer is solely responsible for the content of this announcement.
  • IWG Finance AG plans to propel the global expansion of the real-time telemedicine platform, Doctors365, with its highest single investment in the millions.
  • With an enthusiastic team dedicated to the cause, Doctors365 has won over a generation of customers in Europe for its telemedicine platform.
  • We are thrilled to be part of this pioneering journey," says Claire Summerfield, Chairperson of the Board at IWG AG.

Jet2.com Partners With IWG, Installing Pre-Select to Support Aircraft Weight and Emissions Reductions

Retrieved on: 
Thursday, January 4, 2024
MAX, IWG, 737NG, International, Aircraft, Transport Canada, Boeing, EASA, Jet2.com, Carbon, Tourism, Travel, Airline

Jet2.com has chosen the IWG Pre-Select system, which enables operators to accurately manage the amount of potable water carried based on data of actual usage from IWG's proprietary system, providing weight and jet fuel savings.

Key Points: 
  • Jet2.com has chosen the IWG Pre-Select system, which enables operators to accurately manage the amount of potable water carried based on data of actual usage from IWG's proprietary system, providing weight and jet fuel savings.
  • IWG's Pre-Select is Transport Canada, FAA, and EASA approved, with STCs for Boeing's 737NG and the MAX -8 and -9 aircraft and installations completed in Canada, Europe, and the Americas.
  • "The IWG Pre-Select System provides immediate fuel and carbon savings by reducing aircraft weight through effective water management.
  • Pre-select reduces aircraft weight as much as 180kg, 400lbs on each flight, providing a reduction in fuel required and carbon emissions.

International Water-Guard Industries, Inc. (IWG) Selected to Provide Lavatory Components Including Touchless Faucets and Water Heaters to Airbus

Retrieved on: 
Thursday, November 30, 2023
A320, IWG, International, A330, Water, Engineering, Aviation

SURREY, BC, Nov 30, 2023 - (ACN Newswire) - International Water-Guard Industries, Inc. (IWG) announced today that it has been selected to provide Lavatory components including Touchless Faucets and Water Heaters to Airbus for installation on their A320, A330, and A350 series airframes.

Key Points: 
  • SURREY, BC, Nov 30, 2023 - (ACN Newswire) - International Water-Guard Industries, Inc. (IWG) announced today that it has been selected to provide Lavatory components including Touchless Faucets and Water Heaters to Airbus for installation on their A320, A330, and A350 series airframes.
  • The project begins today and will see IWG products on Airbus aircraft as early as 2025.
    International Water-Guard Industries Inc. is a Canadian aerospace company focused on aircraft potable water components and systems.
  • Our team of aviation water professionals develops innovative solutions that address the requirements and issues surrounding on-board water supply.
  • IWG is a leading provider of flight-certified potable water treatment units, on-demand water heaters, lavatory water components, compact water systems, potable water weight management solutions (Pre-Select), and lightweight valves.

Keros Therapeutics Presents Clinical Data from its KER-050 Program at the 65th American Society of Hematology Annual Meeting and Exposition

Retrieved on: 
Monday, December 11, 2023
Patient, Quality of life, Erythropoietin, Protein, Exposition, Fever, Reticulocyte, Homeostasis, Bone marrow, MF, IWG, Haematopoiesis, Research, Erythropoiesis, Diarrhea, Anemia, KROS, Fatigue, Nausea, Headache, RBC, Iron overload, Society, MDS, Therapy, Weakness, Ruxolitinib, Thrombocytopenia, ASH, TI, Week, Periodic breathing, MBBS, Biomarker, Safety, Acute myeloid leukemia, HTB, Cytopenia, Disorder, Pharmaceutical industry

“Additionally, we are encouraged by the preliminary data from the lowest three dose cohorts from our ongoing Phase 2 clinical trial in MF.

Key Points: 
  • “Additionally, we are encouraged by the preliminary data from the lowest three dose cohorts from our ongoing Phase 2 clinical trial in MF.
  • Data for hematological response and markers of hematopoiesis were presented from exploratory analyses of these mITT24 patients.
  • All data presented from this trial is as of the data cut-off date.
  • 13 of those 18 patients (72.2%) achieved TI for at least 24 weeks over the first 48 weeks of treatment.

argenx Reports Topline Results from ADVANCE-SC Study of VYVGART Hytrulo in Primary Immune Thrombocytopenia

Retrieved on: 
Tuesday, November 28, 2023
Patient, IWG, Pemphigus, Data, Disease, Conference call, Euronext, Neonatal Fc receptor, ITP, Safety, Nursing

The study did not meet the primary endpoint of a sustained platelet count response in chronic ITP patients.

Key Points: 
  • The study did not meet the primary endpoint of a sustained platelet count response in chronic ITP patients.
  • Additional analyses of the dataset are ongoing and the full results will be presented at an upcoming medical meeting and in a peer-reviewed publication.
  • “We are very grateful to everyone involved in the ADVANCE-SC study, especially the patients and their families, the investigators, and our internal team who worked tirelessly to complete this global study.
  • A webcast of the live call and replay may be accessed on the Investors section of the argenx website.

IWG OPENS NEW REGUS IN FINLAND, AS DEMAND FOR HYBRID WORKING RISES

Retrieved on: 
Thursday, December 7, 2023
Marketing, IWG plc, Partnership, Spaces, Interior design, Video game, IWG

With IWG, partners are able to capitalise on this fast-growing sector, while being supported by IWG's unparalleled experience.

Key Points: 
  • With IWG, partners are able to capitalise on this fast-growing sector, while being supported by IWG's unparalleled experience.
  • Hybrid working offers companies a significantly lower cost base with an average saving of 10,000€ per employee[i].
  • Demand for workspaces in the area has performed strongly, with the number of enquiries for space in IWG locations continuing to increase.
  • The building owner decided to invest in the IWG platform to maximise the return on their real estate space by capitalising on the rapidly expanding demand for hybrid working.

Impressive companies, remarkable individuals take centre stage at the 13th PropertyGuru Asia Property Awards (Singapore)

Retrieved on: 
Monday, October 30, 2023
HLB, National Television Award for Special Recognition, LaSalle Investment Management, Singapore Real Estate Exchange, Spark (architects), Continuum, Lion, Marketplace, Personality, Head, Rising Star, GM, Property, Industrial and Commercial Development Corporation, Real estate, ESG, IWG, Tertiary Education Quality and Standards Agency, Guoco Group, Work, Architecture, Growth, Property Report, Winners, Solitaire, REAL, BEST, NYSE, Park, City, The Ritz-Carlton Hotel Company, Film industry, Auction, EY-Parthenon

UOL Group Limited, last year's Best Developer titleholder, was named Best Residential Developer, Best Sustainable Developer, and Best Hospitality Developer.

Key Points: 
  • UOL Group Limited, last year's Best Developer titleholder, was named Best Residential Developer, Best Sustainable Developer, and Best Hospitality Developer.
  • Jules Kay, GM of PropertyGuru Asia Property Awards and Events, said: "The style, sustainability, and smartness of Singapore's world-leading built spaces never fail to impress.
  • Main country winners of the PropertyGuru Asia Property Awards (Singapore) will be eligible to advance to the 18th PropertyGuru Asia Property Awards Grand Final on Friday, 8 December in Bangkok, Thailand.
  • Organised by PropertyGuru Group, the 13th PropertyGuru Asia Property Awards (Singapore) are supported by gold sponsor Mitsubishi Electric Asia Pte Ltd.; official portal partner PropertyGuru.com.sg; official magazine Property Report by PropertyGuru; media partners AspirantSG, d+a Magazine, SquareRooms, and Top 10 Singapore; supporting association Singapore Estate Agents Association; and official supervisor HLB.