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...
22:30 , Dec 12, 2016 |  BC Week In Review  |  Clinical News

Relvar Ellipta regulatory update

GlaxoSmithKline and Innoviva (formerly Theravance Inc.) said Japan approved an expanded label for Relvar Ellipta fluticasone furoate/vilanterol to include treatment of chronic obstructive pulmonary disease (COPD) when concurrent use of an inhaled corticosteroid and an...
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 , 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 , Oct 5, 2015 |  BioCentury  |  Finance

Drawn and quartered

There was no joy to be had in 3Q15, as every biotech market cap band fell by at least 15%. After the carnage only one group - companies valued north of $5 billion - are...
07:00 , Sep 14, 2015 |  BC Week In Review  |  Clinical News

Breo Ellipta: Phase III data

The double-blind, international Phase III SUMMIT trial in 16,485 COPD patients with moderate airflow limitation (50-70% predicted FEV1) and a history or risk of cardiovascular disease showed that once-daily 100/25 ug Breo Ellipta missed the...
01:12 , Sep 9, 2015 |  BC Extra  |  Clinical News

Breo Ellipta misses in Phase III SUMMIT study

Theravance Inc. (NASDAQ:THRX) tumbled $2.43 (15%) to $13.56 on Tuesday after Breo Ellipta fluticasone furoate/vilanterol failed to significantly improve survival in patients with chronic obstructive pulmonary disease (COPD) and a history or increased risk of...
07:00 , May 11, 2015 |  BioCentury  |  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...
07:00 , May 4, 2015 |  BC Week In Review  |  Clinical News

Breo Ellipta fluticasone furoate/vilanterol regulatory update

FDA approved an sNDA for Breo Ellipta fluticasone furoate/vilanterol from GlaxoSmithKline and Theravance as a once-daily maintenance treatment for asthma in adults. The agency issued a complete response letter for the product’s use in patients...
01:18 , May 1, 2015 |  BC Extra  |  Company News

FDA approves Breo Ellipta for adults, not children

FDA approved an sNDA on Thursday for Breo Ellipta fluticasone furoate/vilanterol from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Theravance Inc. (NASDAQ:THRX) to treat asthma in adults. The agency issued a complete response letter for the proposed...