BC Week In Review | Sep 21, 2018
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...
BC Week In Review | Sep 22, 2017
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...
BC Week In Review | Dec 27, 2016
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...
BC Week In Review | Nov 22, 2016
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...
BC Week In Review | Sep 12, 2016
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...
BC Week In Review | Jun 27, 2016
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...
BC Extra | Jun 21, 2016
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...
BC Week In Review | Jun 6, 2016
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...
BioCentury | May 11, 2015
Analyst Picks & Changes

Analyst picks & changes

Analyst picks & changes Analyst picks & changes Company Bank Analyst Coverage Opinion Wk chg 5/8 cls CorMedix Inc. (NYSE-M:CRMD) Roth Capital Partners Scott Henry Downgrade Neutral (from buy) -6% $7.15 Henry downgraded after a...
BC Week In Review | Mar 2, 2015
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...
Items per page:
1 - 10 of 83