GSK wants labeling to reflect all-cause mortality results from the 10,355-patient IMPACT trial of the triple-combination therapy for COPD, but FDA questions whether the survival benefit was driven by the abrupt halt in inhaled corticosteroid treatment for some randomized subjects.
GlaxoSmithKline plc (GSK) and Innoviva, Inc. (INVA) today announced the acceptance of a regulatory submission seeking an additional indication for the use of once-daily, single-inhaler triple therapy, Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol or FF/UMEC/VI) for the treatment of asthma in adults by the European Medicines Agency (EMA).
NEW YORK, Dec 31 (Reuters) - Drugmakers including Pfizer Inc , GlaxoSmithKline PLC and Sanofi SA are planning to hike prices on more than 200 drugs in the United States on Wednesday, according to drugmakers and data analyzed by healthcare research firm 3 Axis Advisors.
GlaxoSmithKline plc (GSK) and Innoviva, Inc. (INVA) today announced the filing of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) seeking an additional indication for the use of once-daily, single-inhaler triple therapy, Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol or FF/UMEC/VI), for the treatment of asthma in adults. Trelegy Ellipta was approved in the US in September 2017 for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD).
The Food and Drug Administration rejected AstraZeneca's triple combination inhaler PT010 for chronic obstructive pulmonary disease (COPD), which has already received approval in Japan as Breztri Aerosphere.
The U.S. Food and Drug Administration declined to approve AstraZeneca Plc’s combination therapy to treat smoker’s lung, the drugmaker said on Tuesday.
GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced headline results from the pivotal phase III CAPTAIN study of once-daily single inhaler triple therapy Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol: FF/UMEC/VI) compared to Relvar/Breo Ellipta (FF/VI), in the treatment of patients living with uncontrolled asthma.
With generics attacking Advair, GlaxoSmithKline has talked up prospects for 3-in-1 respiratory med Trelegy. Now, the company has data in hand that could help it move into the asthma arena—though it's not all positive.
GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced headline results from the pivotal phase III CAPTAIN study of once-daily single inhaler triple therapy Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol: FF/UMEC/VI) compared to Relvar/Breo Ellipta (FF/VI), in the treatment of patients living with uncontrolled asthma.
When Kåre Schultz joined Teva as CEO back in November 2017, the drugmaker was in a world of hurt. It was saddled with debt, costs were high and sales were falling. Now, Teva is in the second year of a two-year cost-cutting campaign, and so far the drugmaker has chopped billions in annual expenses.