London, UK, 23-10-2013 — /EuropaWire/ — GlaxoSmithKline plc (LSE:GSK) today announced the submission of a New Drug Application (NDA) in the US for the once daily inhaled corticosteroid (ICS) treatment, fluticasone furoate (FF), administered using the ELLIPTA™ dry powder inhaler.
The NDA has been submitted to the US Food and Drug Administration (FDA) for FF monotherapy (100mcg and 200mcg doses) as a once-daily inhaled dry powder maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older.
Regulatory filings for FF monotherapy are planned in other countries from 2014 onwards. FF administered using the ELLIPTA™ dry powder inhaler is an investigational medicine and is not currently approved anywhere in the world.
ELLIPTA™ is a trademark of the GlaxoSmithKline group of companies.
GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.
| GSK enquiries: | ||||
| UK Media enquiries: | David Mawdsley | +44 (0) 20 8047 5502 | (London) | |
| Simon Steel | +44 (0) 20 8047 5502 | (London) | ||
| David Daley | +44 (0) 20 8047 5502 | (London) | ||
| Catherine Hartley | +44 (0) 20 8047 5502 | (London) | ||
| US Media enquiries: | Stephen Rea | +1 215 751 4394 | (Philadelphia) | |
| Karen Collins | +1 919 483 2527 | (North Carolina) | ||
| Melinda Stubbee | +1 919 483 2510 | (North Carolina) | ||
| Juan Carlos Molina | +1 919 483 0471 | (North Carolina) | ||
| Bradd Pavur | +1 919 483 0044 | (North Carolina) | ||
| Analyst/Investor enquiries: | Ziba Shamsi | + 44 (0) 20 8047 3289 | (London) | |
| Kirsty Collins (SRI & CG) | +44 20 8047 5534 | (London) | ||
| Tom Curry | + 1 215 751 5419 | (Philadelphia) | ||
| Gary Davies | + 44 (0) 20 8047 5503 | (London) | ||
| James Dodwell | + 44 (0) 20 8047 2406 | (London) | ||
| Jeff McLaughlin | + 1 215 751 7002 | (Philadelphia) | ||
| Lucy Singah | +44 (0) 20 8047 2248 | (London) | ||
| Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK’ s operations are described under Item 3.D ‘Risk factors’ in the company’s Annual Report on Form 20-F for 2012. |
EDITOR'S PICK:
- New IDTechEx Report Predicts Regulatory Shifts Will Transform the Electric Light Commercial Vehicle Market
- Almost 1 in 4 Planes Sold in 2045 to be Battery Electric, Finds IDTechEx Sustainable Aviation Market Report
- Digi Communications N.V. announces the release of Q3 2024 financial results
- Digi Communications NV announces Investors Call for the presentation of the Q3 2024 Financial Results
- Pilot and Electriq Global announce collaboration to explore deployment of proprietary hydrogen transport, storage and power generation technology
- Digi Communications N.V. announces the conclusion of a Memorandum of Understanding by its subsidiary in Romania
- Digi Communications N.V. announces that the Company’s Portuguese subsidiary finalised the transaction with LORCA JVCO Limited
- Digi Communications N.V. announces that the Portuguese Competition Authority has granted clearance for the share purchase agreement concluded by the Company’s subsidiary in Portugal
- OMRON Healthcare introduceert nieuwe bloeddrukmeters met AI-aangedreven AFib-detectietechnologie; lancering in Europa september 2024
- OMRON Healthcare dévoile de nouveaux tensiomètres dotés d’une technologie de détection de la fibrillation auriculaire alimentée par l’IA, lancés en Europe en septembre 2024
- OMRON Healthcare presenta i nuovi misuratori della pressione sanguigna con tecnologia di rilevamento della fibrillazione atriale (AFib) basata sull’IA, in arrivo in Europa a settembre 2024
- OMRON Healthcare presenta los nuevos tensiómetros con tecnología de detección de fibrilación auricular (FA) e inteligencia artificial (IA), que se lanzarán en Europa en septiembre de 2024
- Alegerile din Moldova din 2024: O Bătălie pentru Democrație Împotriva Dezinformării
- Northcrest Developments launches design competition to reimagine 2-km former airport Runway into a vibrant pedestrianized corridor, shaping a new era of placemaking on an international scale
- The Road to Sustainable Electric Motors for EVs: IDTechEx Analyzes Key Factors
- Infrared Technology Breakthroughs Paving the Way for a US$500 Million Market, Says IDTechEx Report
- MegaFair Revolutionizes the iGaming Industry with Skill-Based Games
- European Commission Evaluates Poland’s Media Adherence to the Right to be Forgotten
- Global Race for Autonomous Trucks: Europe a Critical Region Transport Transformation
- Digi Communications N.V. confirms the full redemption of €450,000,000 Senior Secured Notes
- AT&T Obtiene Sentencia Contra Grupo Salinas Telecom, Propiedad de Ricardo Salinas, Sus Abogados se Retiran Mientras Él Mueve Activos Fuera de EE.UU. para Evitar Pagar la Sentencia
- Global Outlook for the Challenging Autonomous Bus and Roboshuttle Markets
- Evolving Brain-Computer Interface Market More Than Just Elon Musk’s Neuralink, Reports IDTechEx
- Latin Trails Wraps Up a Successful 3rd Quarter with Prestigious LATA Sustainability Award and Expands Conservation Initiatives ↗️
- Astor Asset Management 3 Ltd leitet Untersuchung für potenzielle Sammelklage gegen Ricardo Benjamín Salinas Pliego von Grupo ELEKTRA wegen Marktmanipulation und Wertpapierbetrug ein
- Digi Communications N.V. announces that the Company’s Romanian subsidiary exercised its right to redeem the Senior Secured Notes due in 2025 in principal amount of €450,000,000
- Astor Asset Management 3 Ltd Inicia Investigación de Demanda Colectiva Contra Ricardo Benjamín Salinas Pliego de Grupo ELEKTRA por Manipulación de Acciones y Fraude en Valores
- Astor Asset Management 3 Ltd Initiating Class Action Lawsuit Inquiry Against Ricardo Benjamín Salinas Pliego of Grupo ELEKTRA for Stock Manipulation & Securities Fraud
- Digi Communications N.V. announced that its Spanish subsidiary, Digi Spain Telecom S.L.U., has completed the first stage of selling a Fibre-to-the-Home (FTTH) network in 12 Spanish provinces
- Natural Cotton Color lancia la collezione "Calunga" a Milano
- Astor Asset Management 3 Ltd: Salinas Pliego Incumple Préstamo de $110 Millones USD y Viola Regulaciones Mexicanas
- Astor Asset Management 3 Ltd: Salinas Pliego Verstößt gegen Darlehensvertrag über 110 Mio. USD und Mexikanische Wertpapiergesetze
- ChargeEuropa zamyka rundę finansowania, której przewodził fundusz Shift4Good tym samym dokonując historycznej francuskiej inwestycji w polski sektor elektromobilności
- Strengthening EU Protections: Robert Szustkowski calls for safeguarding EU citizens’ rights to dignity
- Digi Communications NV announces the release of H1 2024 Financial Results
- Digi Communications N.V. announces that conditional stock options were granted to a director of the Company’s Romanian Subsidiary
- Digi Communications N.V. announces Investors Call for the presentation of the H1 2024 Financial Results
- Digi Communications N.V. announces the conclusion of a share purchase agreement by its subsidiary in Portugal
- Digi Communications N.V. Announces Rating Assigned by Fitch Ratings to Digi Communications N.V.
- Digi Communications N.V. announces significant agreements concluded by the Company’s subsidiaries in Spain
- SGW Global Appoints Telcomdis as the Official European Distributor for Motorola Nursery and Motorola Sound Products
- Digi Communications N.V. announces the availability of the instruction regarding the payment of share dividend for the 2023 financial year
- Digi Communications N.V. announces the exercise of conditional share options by the executive directors of the Company, for the year 2023, as approved by the Company’s Ordinary General Shareholders’ Meetings from 18th May 2021 and 28th December 2022
- Digi Communications N.V. announces the granting of conditional stock options to Executive Directors of the Company based on the general shareholders’ meeting approval from 25 June 2024
- Digi Communications N.V. announces the OGMS resolutions and the availability of the approved 2023 Annual Report
- Czech Composer Tatiana Mikova Presents Her String Quartet ‘In Modo Lidico’ at Carnegie Hall
- SWIFTT: A Copernicus-based forest management tool to map, mitigate, and prevent the main threats to EU forests
- WickedBet Unveils Exciting Euro 2024 Promotion with Boosted Odds
- Museum of Unrest: a new space for activism, art and design
- Digi Communications N.V. announces the conclusion of a Senior Facility Agreement by companies within Digi Group
- Digi Communications N.V. announces the agreements concluded by Digi Romania (formerly named RCS & RDS S.A.), the Romanian subsidiary of the Company
- Green Light for Henri Hotel, Restaurants and Shops in the “Alter Fischereihafen” (Old Fishing Port) in Cuxhaven, opening Summer 2026
- Digi Communications N.V. reports consolidated revenues and other income of EUR 447 million, adjusted EBITDA (excluding IFRS 16) of EUR 140 million for Q1 2024
- Digi Communications announces the conclusion of Facilities Agreements by companies from Digi Group
- Digi Communications N.V. Announces the convocation of the Company’s general shareholders meeting for 25 June 2024 for the approval of, among others, the 2023 Annual Report
- Digi Communications NV announces Investors Call for the presentation of the Q1 2024 Financial Results
- Digi Communications intends to propose to shareholders the distribution of dividends for the fiscal year 2023 at the upcoming General Meeting of Shareholders, which shall take place in June 2024
- Digi Communications N.V. announces the availability of the Romanian version of the 2023 Annual Report
- Digi Communications N.V. announces the availability of the 2023 Annual Report
- International Airlines Group adopts Airline Economics by Skailark ↗️
- BevZero Spain Enhances Sustainability Efforts with Installation of Solar Panels at Production Facility
- Digi Communications N.V. announces share transaction made by an Executive Director of the Company with class B shares
- BevZero South Africa Achieves FSSC 22000 Food Safety Certification
- Digi Communications N.V.: Digi Spain Enters Agreement to Sell FTTH Network to International Investors for Up to EUR 750 Million
- Patients as Partners® Europe Announces the Launch of 8th Annual Meeting with 2024 Keynotes and Topics
- driveMybox continues its international expansion: Hungary as a new strategic location
- Monesave introduces Socialised budgeting: Meet the app quietly revolutionising how users budget
- Digi Communications NV announces the release of the 2023 Preliminary Financial Results
- Digi Communications NV announces Investors Call for the presentation of the 2023 Preliminary Financial Results
- Lensa, един от най-ценените търговци на оптика в Румъния, пристига в България. Първият шоурум е открит в София
- Criando o futuro: desenvolvimento da AENO no mercado de consumo em Portugal
- Digi Communications N.V. Announces the release of the Financial Calendar for 2024
- Customer Data Platform Industry Attracts New Participants: CDP Institute Report
- eCarsTrade annonce Dirk Van Roost au poste de Directeur Administratif et Financier: une décision stratégique pour la croissance à venir
- BevZero Announces Strategic Partnership with TOMSA Desil to Distribute equipment for sustainability in the wine industry, as well as the development of Next-Gen Dealcoholization technology
- Digi Communications N.V. announces share transaction made by a Non-Executive Director of the Company with class B shares
- Digi Spain Telecom, the subsidiary of Digi Communications NV in Spain, has concluded a spectrum transfer agreement for the purchase of spectrum licenses
- Эксперт по торговле акциями Сергей Левин запускает онлайн-мастер-класс по торговле сырьевыми товарами и хеджированию
- Digi Communications N.V. announces the conclusion by Company’s Portuguese subsidiary of a framework agreement for spectrum usage rights
- North Texas Couple Completes Dream Purchase of Ouray’s Iconic Beaumont Hotel
- Предприниматель и филантроп Михаил Пелег подчеркнул важность саммита ООН по Целям устойчивого развития 2023 года в Нью-Йорке
- Digi Communications NV announces the release of the Q3 2023 Financial Results
- IQ Biozoom Innovates Non-Invasive Self-Testing, Empowering People to Self-Monitor with Laboratory Precision at Home
- BevZero Introduces Energy Saving Tank Insulation System to Europe under name “BevClad”
- Motorvision Group reduces localization costs using AI dubbing thanks to partnering with Dubformer
- Digi Communications NV Announces Investors Call for the Q3 2023 Financial Results
- Jifiti Granted Electronic Money Institution (EMI) License in Europe
- Предприниматель Михаил Пелег выступил в защиту образования и грамотности на мероприятии ЮНЕСКО, посвящённом Международному дню грамотности
- VRG Components Welcomes New Austrian Independent Agent
- Digi Communications N.V. announces that Digi Spain Telecom S.L.U., its subsidiary in Spain, and abrdn plc have completed the first investment within the transaction having as subject matter the financing of the roll out of a Fibre-to-the-Home (“FTTH”) network in Andalusia, Spain
- Продюсер Михаил Пелег, как сообщается, работает над новым сериалом с участием крупной голливудской актрисы
- Double digit growth in global hospitality industry for Q4 2023
- ITC Deploys Traffic Management Solution in Peachtree Corners, Launches into United States Market
- Cyviz onthult nieuwe TEMPEST dynamische controlekamer in Benelux, Nederland
- EU-Funded CommuniCity Launches its Second Open Call
- Astrologia pode dar pistas sobre a separação de Sophie Turner e Joe Jonas
- La astrología puede señalar las razones de la separación de Sophie Turner y Joe Jonas
- Empowering Europe against infectious diseases: innovative framework to tackle climate-driven health risks
- Montachem International Enters Compostable Materials Market with Seaweed Resins Company Loliware
- Digi Communications N.V. announces that its Belgian affiliated companies are moving ahead with their operations
- Digi Communications N.V. announces the exercise of conditional share options by an executive director of the Company, for the year 2022, as approved by the Company’s Ordinary General Shareholders’ Meeting from 18 May 2021
- Digi Communications N.V. announces the availability of the instruction regarding the payment of share dividend for the 2022 financial year
- Digi Communications N.V. announces the availability of the 2022 Annual Report
- Digi Communications N.V. announces the general shareholders’ meeting resolutions from 18 August 2023 approving amongst others, the 2022 Annual Accounts
- Русские эмигранты усиливают призывы «Я хочу, чтобы вы жили» через искусство
- BevZero Introduces State-of-the-Art Mobile Flash Pasteurization Unit to Enhance Non-Alcoholic Beverage Stability at South Africa Facility
- Russian Emigrés Amplify Pleas of “I Want You to Live” through Art
- Digi Communications NV announces the release of H1 2023 Financial Results
- Digi Communications NV Announces Investors Call for the H1 2023 Financial Results
- Digi Communications N.V. announces the convocation of the Company’s general shareholders meeting for 18 August 2023 for the approval of, among others, the 2022 Annual Report
- “Art Is Our Weapon”: Artists in Exile Deploy Their Talents in Support of Peace, Justice for Ukraine
- Digi Communications N.V. announces the availability of the 2022 Annual Financial Report
- “AmsEindShuttle” nuevo servicio de transporte que conecta el aeropuerto de Eindhoven y Ámsterdam
- Un nuovo servizio navetta “AmsEindShuttle” collega l’aeroporto di Eindhoven ad Amsterdam
- Digi Communications N.V. announces the conclusion of an amendment agreement to the Facility Agreement dated 26 July 2021, by the Company’s Spanish subsidiary
- Digi Communications N.V. announces an amendment of the Company’s 2023 financial calendar
- iGulu F1: Brewing Evolution Unleashed
- Почему интерактивная «Карта мира» собрала ключевые антивоенные сообщества россиян по всему миру и становится для них важнейшим инструментом
- Hajj Minister meets EU ambassadors to Saudi Arabia
- Online Organizing Platform “Map of Peace” Emerges as Key Tool for Diaspora Activists
- Digi Communications N.V. announces that conditional stock options were granted to executive directors of the Company based on the general shareholders’ meeting approval from 18 May 2021
- Digi Communications N.V. announces the release of the Q1 2023 financial results
- AMBROSIA – A MULTIPLEXED PLASMO-PHOTONIC BIOSENSING PLATFORM FOR RAPID AND INTELLIGENT SEPSIS DIAGNOSIS AT THE POINT-OF-CARE
- Digi Communications NV announces Investors Call for the Q1 2023 Financial Results presentation
- Digi Communications N.V. announces the amendment of the Company’s 2023 financial calendar
- Digi Communications N.V. announces the conclusion of two Facilities Agreements by the Company’s Romanian subsidiary
- Digi Communications N.V. announces the conclusion of a Senior Facility Agreement by the Company’s Romanian subsidiary
- Patients as Partners Europe Returns to London and Announces Agenda Highlights
- GRETE PROJECT RESULTS PRESENTED TO TEXTILE INDUSTRY STAKEHOLDERS AT INTERNATIONAL CELLULOSE FIBRES CONFERENCE
- Digi Communications N.V. announces Digi Spain Telecom S.L.U., its subsidiary in Spain, entered into an investment agreement with abrdn to finance the roll out of a Fibre-to-the-Home (FTTH) network in Andalusia, Spain
- XSpline SPA / University of Linz (Austria): the first patient has been enrolled in the international multicenter clinical study for the Cardiac Resynchronization Therapy DeliveRy guided by non-Invasive electrical and VEnous anatomy assessment (CRT-DRIVE)
- Franklin Junction Expands Host Kitchen® Network To Europe with Digital Food Hall Pioneer Casper
- Unihertz a dévoilé un nouveau smartphone distinctif, Luna, au MWC 2023 de Barcelone
- Unihertz Brachte ein Neues, Markantes Smartphone, Luna, auf dem MWC 2023 in Barcelona
- Editor's pick archive....
