16:42 , Sep 21, 2018 |  BC Week In Review  |  Clinical News

AZ says Phase IIIb data of Bevespi Aerosphere in COPD are 'inconsistent with previous data'

AstraZeneca plc (LSE:AZN; NYSE:AZN) said Bevespi Aerosphere glycopyrrolate/formoterol fumarate met one of three primary endpoints in the Phase IIIb AERISTO trial to treat moderate to very severe chronic obstructive pulmonary disease (COPD). Bevespi Aerosphere was...
19:53 , Sep 22, 2017 |  BC Week In Review  |  Clinical News

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

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Innoviva Inc. (NASDAQ:INVA) reported data from the Phase III IMPACT trial in 10,355 chronic obstructive pulmonary disease (COPD) patients showing that once-daily Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) met the primary...
17:14 , Dec 27, 2016 |  BC Week In Review  |  Clinical News

Fluticasone furoate/umeclidinium/vilanterol: Ph III CAPTAIN started

GlaxoSmithKline began the double-blind, international Phase III CAPTAIN trial to compare once-daily fluticasone furoate/umeclidinium/vilanterol delivered in GSK’s Ellipta dry powder inhaler vs. once-daily inhaled Relvar/ Breo Ellipta fluticasone furoate/vilanterol in about 2,250 patients with inadequately...
23:37 , Nov 22, 2016 |  BC Week In Review  |  Clinical News

Fluticasone furoate/umeclidinium/vilanterol regulatory update

GlaxoSmithKline submitted an NDA to FDA for fluticasone furoate/umeclidinium/vilanterol to treat chronic obstructive pulmonary disease (COPD). GSK plans to submit an MAA to EMA by year end. The product is a combination of 62.5 µg...
07:00 , Sep 12, 2016 |  BC Week In Review  |  Clinical News

Fluticasone furoate/umeclidinium/vilanterol: Additional Phase III data

Additional data from the double-blind, double-dummy, international Phase III FULFIL trial in 1,810 COPD patients showed that once-daily inhaled fluticasone furoate/umeclidinium/vilanterol delivered in GlaxoSmithKline’s Ellipta dry powder inhaler significantly improved trough FEV1 by 179 mL...
07:00 , Jun 27, 2016 |  BC Week In Review  |  Clinical News

Fluticasone furoate/umeclidinium/vilanterol: Phase III data

Top-line data from the double-blind, double-dummy, international Phase III FULFIL trial in 1,810 COPD patients showed that once-daily inhaled fluticasone furoate/umeclidinium/vilanterol delivered in GlaxoSmithKline’s Ellipta dry powder inhaler met the co-primary endpoints of improving trough...
00:38 , Jun 21, 2016 |  BC Extra  |  Clinical News

GSK/Innoviva COPD combo passes Phase III test

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Innoviva Inc. (NASDAQ:INVA) said fluticasone furoate/umeclidinium/vilanterol met the co-primary endpoints in the Phase III FULFIL study to treat chronic obstructive pulmonary disease. GSK expects to submit regulatory applications for the...
07:00 , Jun 6, 2016 |  BC Week In Review  |  Clinical News

Fluticasone furoate/umeclidinium/vilanterol regulatory update

GlaxoSmithKline moved up its expected NDA submission to FDA for fluticasone furoate/umeclidinium/vilanterol to treat chronic obstructive pulmonary disease (COPD) to by year end from 1H18 following discussions with the agency. GSK remains on track to...
07:00 , May 11, 2015 |  BioCentury  |  Analyst Picks & Changes

Analyst picks & changes

Analyst picks & changes...
08:00 , Mar 2, 2015 |  BC Week In Review  |  Clinical News

Fluticasone furoate/vilanterol/umeclidinium: Phase III started

GlaxoSmithKline and Theravance began the double-blind, double-dummy, international Phase III FULFIL trial to compare once-daily fluticasone furoate/vilanterol/umeclidinium delivered via GSK’s Ellipta inhaler vs. twice-daily budesonide/formoterol delivered via Turbohaler dry powder inhaler for 24 weeks in...