BioCentury | Sep 11, 2020
Product Development

Sept. 10 Quick Takes: approvals for Zai, GSK and Phase III readouts for Satsuma, Amryt and Takeda; plus Houston Methodist, MassBio and JPM

...Kong and Macau.FDA approves GSK’s Trelegy Ellipta for asthmaOn Wednesday, FDA approved an sNDA for Trelegy Ellipta umeclidinium bromide/fluticasone furoate/vilanterol...
...from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) is the first LABA/LAMA/inhaled corticosteroid combination approved for the indication. Trelegy Ellipta...
BioCentury | May 1, 2020
Regulation

CHMP backs new therapy for 1L AML, triple combos for asthma

...app. If approved, Novartis’ combos would be the first triple therapies approved for asthma. Trelegy Ellipta umeclidinium bromide/fluticasone furoate/vilanterol...
BioCentury | Mar 11, 2020
Politics, Policy & Law

FDA postpones meetings and inspections, grounds staff to combat COVID-19

...Pulmonary-Allergy Drugs Advisory Committee to discuss an sNDA from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) for Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol...
BioCentury | Feb 21, 2020
Product Development

Feb. 20 Product Development Quick Takes: Priority Review puts BioMarin on track to score first hemophilia gene therapy approval in U.S.; plus Gilead-CDC, Genfit

...Advisory Committee will hold a meeting on April 21 to discuss an sNDA for Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol...
...bmn 270) Descovy (Brand), emtricitabine/tenofovir alafenamide (Generic), F/TAF (Informal), Descovy (Other) Truvada, emtricitabine/tenofovir elafibranor (GFT505) Trelegy Ellipta, Umeclidinium bromide/fluticasone furoate/vilanterol, Fluticasone furoate/vilanterol/umeclidinium, fluticasone furoate/umeclidinium/vilanterol, FF/UMEC/VI...
BioCentury | May 2, 2019
Clinical News

May 2 Clinical Quick Takes: Biogen, GSK, Celgene/bluebird, Genkyotex

...in Phase III GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Innoviva Inc. (NASDAQ:INVA) said once-daily Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI...
...member 17; SOD1 - Superoxide dismutase 1 Brian Moy, Assistant Editor bb2121 BIIB067, IONIS-SOD1Rx GKT831, gkt137831 Trelegy Ellipta, Umeclidinium bromide/fluticasone furoate/vilanterol, Fluticasone furoate/vilanterol/umeclidinium, fluticasone furoate/umeclidinium/vilanterol, FF/UMEC/VI...
BioCentury | Apr 6, 2019
Finance

Big caps under pressure

...neuropathy (LHON) Additional phase III data 2Q19 GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) / Innoviva Inc. (NASDAQ:INVA) Trelegy Ellipta...
BioCentury | Oct 31, 2018
Company News

GSK cuts some respiratory targets, keeps others in play

...to Support Nucala for COPD" ). GSK's asthma franchise includes established programs Trelegy Ellipta, Umeclidinium bromide/fluticasone furoate/vilanterol and Fluticasone furoate/vilanterol/umeclidinium...
BioCentury | Oct 25, 2017
Company News

GSK's interest in expanding consumer healthcare business concerns investors

...Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol for maintenance treatment of chronic obstructive pulmonary disease (COPD). In September, FDA approved Trelegy Ellipta...
...at constant exchange rates from 3Q16, and just shy of the £7.88 billion consensus estimate. Chris Lieu Shingrix Trelegy Ellipta GlaxoSmithKline...
BioCentury | Oct 6, 2017
Finance

Bargain shopping

...Benlysta belimumab to treat systemic lupus erythematosus (SLE) GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) FDA approves Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol...
BioCentury | Sep 22, 2017
Clinical News

GSK's Trelegy Ellipta meets in Phase III IMPACT trial for COPD

...IMPACT trial in 10,355 chronic obstructive pulmonary disease (COPD) patients showing that once-daily Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI...
...Trelegy Ellipta is the first once-daily single inhaler triple therapy approved for COPD in the U.S. Trelegy Ellipta...
...Inc. (NASDAQ:INVA), South San Francisco, Calif. GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), London, U.K. Product: Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI...
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