FiercePharma

RELVAR® ELLIPTA® receives European marketing authorisation for the treatment of asthma and COPD

LONDON, UNITED KINGDOM and SOUTH SAN FRANCISCO, CA--(Marketwired - Nov 18, 2013) - GlaxoSmithKline plc (GSK) and Theravance, Inc. (NASDAQ: THRX) announced today that the European Commission has ...
FiercePharma

RELVAR™ ELLIPTA™ receives positive opinion from the CHMP in Europe for the treatment of asthma and COPD

GlaxoSmithKline plc (LSE/NYSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a ...
Business Wire

Phase III CAPTAIN Study of Trelegy Ellipta in Patients with Asthma Meets Primary Endpoint

Trelegy Ellipta is a combination of three molecules in a single inhaler. It contains fluticasone furoate, an inhaled corticosteroid, umeclidinium, a long-acting muscarinic antagonist; and vilanterol, ...
Medscape

CHMP Backs Relvar Ellipta for Asthma, COPD

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for fluticasone furoate/vilanterol (FF/VI) (Relvar Ellipta, ...
Business Wire

GSK Submits EU Filing for Extended Use of Relvar Ellipta in Patients with Controlled Asthma on an ICS/LABA Combination

LONDON--(BUSINESS WIRE)--GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced a submission to the European Medicines Agency (EMA) for the extended use of once-daily ...
The Financial

Relvar Ellipta 100/25 mcg gains approval in Japan for use in patients with COPD

The FINANCIAL — GlaxoSmithKline plc on December 2 announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Relvar Ellipta (fluticasone furoate / vilanterol 100/25 mcg) ...
FierceBiotech

GSK and Theravance Announce Regulatory Submissions for FF/VI in the US and Europe

Relvar(TM) and Breo(TM) Proposed as Brand Names for FF/VI in EU and US; New Dry Powder Inhaler Proposed to be Named Ellipta(TM) LONDON and SOUTH SAN FRANCISCO, Calif., Jul 13, 2012 -- GlaxoSmithKline ...
FierceBiotech

GSK and Theravance announce initiation of phase III programme with fixed dose triple combination treatment FF/UMEC/VI in patients with COPD

GlaxoSmithKline plc (LSE/NYSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced the start of a global phase III study, known as IMPACT, to evaluate the efficacy and safety of the 'closed' ...
Nasdaq

FDA Approves Trelegy Ellipta as the First Once-Daily Single Inhaler Triple Therapy for the Treatment of Both Asthma and COPD in the US

New asthma indication for Trelegy Ellipta introduces an important option for patients to the current treatment paradigm The FDA-approved strength for both COPD and asthma is fluticasone furoate / ...
Medscape

CHMP Backs Revinty Ellipta for Asthma, COPD

The European Medicine Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the fixed-dose combination of fluticasone furoate and vilanterol (FF/VI) (Revinty ...