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AstraZeneca plc

GSK, Innoviva seek EU nod for triple combo inhaled therapy

December 5, 2016 By Sarah Faulkner

GlaxoSmithKline

GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) said last week that they filed a regulatory submission with the European Medicines Agency for the once-daily, triple-combination therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) for patients with chronic obstructive pulmonary disease. Last month, the companies submitted a new drug application for the inhaled therapy to the FDA for approval in the U.S. The triple combination therapy is […]

Filed Under: Drug-Device Combinations, Featured, Pharmaceuticals, Regulatory/Compliance, Respiratory Tagged With: AstraZeneca plc, GlaxoSmithKline plc, Innoviva

GSK files for FDA approval of inhaled triple-combo therapy for COPD

November 21, 2016 By Sarah Faulkner

GlaxoSmithKline

GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) said today that GSK filed a regulatory submission with the FDA for the once-daily, closed triple combination therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) for patients with chronic obstructive pulmonary disease. The triple-combo therapy includes 3 drugs: fluticasone furoate, an inhaled corticosteroid; umeclidinium, a long-acting muscarinic antagonist; vilanterol, a long-acting beta2-adrenergic agonist. The medicines […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Respiratory Tagged With: AstraZeneca plc, GlaxoSmithKline plc, Innoviva

AstraZeneca, Bespak ink deal for metered-dose inhaler

September 12, 2016 By Sarah Faulkner

Consort Medical's Bespak, Astra Zeneca

AstraZeneca (NYSE:AZN) said last week that it inked a multi-year commercial supply deal with Consort Medical (LON:CSRT) subsidiary Bespak for its pressurized metered-dose inhaler technology. Bespak will supply inhaler valves and actuators for use with AstraZeneca’s inhaled aerosol treatment for chronic obstructive pulmonary disease. AstraZeneca won FDA approval in April for the aerosol, Bevespi Aerosphere […]

Filed Under: Drug-Device Combinations, Research & Development Tagged With: AstraZeneca plc, Consort Medical

GlaxoSmithKline’s triple combo with Innoviva tops Symbicort Turbohaler in COPD

September 7, 2016 By Sarah Faulkner

GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) yesterday touted results from a Phase III study investigating the triple-combination therapy fluticasone furoate/umeclidnium/vilanterol for patients with chronic obstructive pulmonary disease. The 1,810-patient Fulfil study is a randomized, double-blinded trial comparing once-daily FF/UMEC/VI against AstraZeneca‘s (NYSE:AZN) Symbicort Turbohaler dry powder inhaler, a twice-daily combination of budesonide and formoterol. Patients in the FF/UMEC/VI […]

Filed Under: Clinical Trials, Drug-Device Combinations, Research & Development Tagged With: AstraZeneca plc, GlaxoSmithKline plc, Innoviva

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