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Innoviva

GSK seeks additional asthma indication for Trelegy Ellipta

October 3, 2019 By Sean Whooley

GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) said yesterday that they filed a supplemental New Drug Application with the FDA, seeking an additional indication for GSK’s Trelegy Ellipta inhaler for the treatment of asthma in adults. The once-daily, single-inhaler triple-therapy device received FDA approval for the treatment of chronic obstructive pulmonary disease in September 2017. Trelegy Ellipta has not […]

Filed Under: Drug-Device Combinations, Food & Drug Administration (FDA), Regulatory/Compliance, Respiratory Tagged With: GlaxoSmithKline plc, Innoviva

Innoviva-GSK project Trelegy Ellipta meets main endpoint in asthma pivotal trial

May 6, 2019 By Brad Perriello

A combination drug-device therapy developed by GlaxoSmithKline(NYSE:GSK) and Innoviva (NSDQ:INVA) for asthma, Trelegy Ellipta, met the primary endpoint in its pivotal trial, the companies said last week. The Trelegy Ellipta inhaler is designed to deliver a single daily dose of three drugs – fluticasone furoate, umeclidinium and vilanterol – to patients with uncontrolled asthma. The 2,436-patient Captain trial […]

Filed Under: Clinical Trials, Drug-Device Combinations, Respiratory Tagged With: GlaxoSmithKline plc, Innoviva

GSK seeks expanded label for Trelegy Ellipta inhaler in EU

February 14, 2018 By Sarah Faulkner

GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) have submitted data to the European Medicines Agency in the hopes of expanding the label for its once-daily, triple combination inhaler, Trelegy Ellipta. The drug-device combo was approved in Europe in November last year as a maintenance treatment for adult patients with moderate to severe chronic obstructive pulmonary disease who are not adequately […]

Filed Under: Clinical Trials, Drug-Device Combinations, Pharmaceutical, Respiratory, Wall Street Beat Tagged With: GlaxoSmithKline plc, Innoviva

Innoviva posts Street-beating Q4, FY17 earnings

February 9, 2018 By Sarah Faulkner

Shares in Innoviva (NSDQ:INVA) rose today after the company topped expectations on Wall Street with its fourth quarter and full-year financial results. The Brisbane, Calif.-based company posted profits of $58.4 million, or 55¢ per share, on sales of $69.5 million for the 3 months ended Dec. 31, for bottom-line growth of 129% on sales growth of 59% […]

Filed Under: Drug-Device Combinations, MassDevice Earnings Roundup, Pharmaceutical, Respiratory, Wall Street Beat Tagged With: Innoviva

EMA committee backs label change for GSK’s Relvar Ellipta asthma therapy

January 26, 2018 By Sarah Faulkner

GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) said today that a European Medicines Agency committee has backed an updated label for its once-daily asthma therapy, Relvar Ellipta. If granted marketing authorization by the European Commission, the combination drug treatment will be approved for use in patients whose asthma is already controlled on an inhaled corticosteroid and a long-acting beta-2-agonist. Get […]

Filed Under: Drug-Device Combinations, Pharmaceutical, Regulatory/Compliance, Respiratory, Wall Street Beat Tagged With: GlaxoSmithKline plc, Innoviva

GSK, Innoviva seek expanded label for triple inhaler

November 27, 2017 By Sarah Faulkner

GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) have submitted data from the landmark Impact trial to the FDA in the hopes of landing an expanded label for the Trelegy Ellipta triple inhaler. The two companies are hoping that their therapy could be used to treat airflow obstruction and to reduce exacerbations in people with chronic obstructive pulmonary disease. Get the […]

Filed Under: Clinical Trials, Drug-Device Combinations, Food & Drug Administration (FDA), Pharmaceutical, Regulatory/Compliance, Respiratory, Wall Street Beat Tagged With: GlaxoSmithKline plc, Innoviva

Following regulatory win, GSK & Innoviva tout data for once-daily triple-med inhaler

September 20, 2017 By Sarah Faulkner

GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) notched a win this week after the FDA approved its once-daily, triple combination therapy for the treatment of chronic obstructive pulmonary disease. Last week, an EU agency recommended the inhaler’s approval. Now, the companies are touting results from a late-stage trial of Trelegy Ellipta, which is composed of an inhaled corticosteroid, a long-acting muscarinic antagonist and […]

Filed Under: Clinical Trials, Drug-Device Combinations, Pharmaceutical, Respiratory, Wall Street Beat Tagged With: GlaxoSmithKline plc, Innoviva

FDA approves GSK’s 3-in-1 Trelega Ellipta inhaler

September 19, 2017 By Sarah Faulkner

The FDA has approved the triple inhaler developed by GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) to treat chronic obstructive pulmonary disease, the companies reported today. The Trelega Ellipta dry powder inhaler uses fluticasone furoate, umeclidinium and vilanterol to help adults with COPD manage the condition. It is the first once-daily product approved in the U.S. that combines three active molecules […]

Filed Under: Drug-Device Combinations, Food & Drug Administration (FDA), Pharmaceutical, Respiratory, Wall Street Beat Tagged With: GlaxoSmithKline plc, Innoviva

GSK’s triple-med COPD inhaler wins recommendation for approval in EU

September 15, 2017 By Sarah Faulkner

GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) said today that a European Medicines Agency panel recommended marketing authorization for the Trelegy Ellipta triple-combination inhaler for adults with COPD. The device uses fluticasone furoate, umeclidinium and vilanterol to help adults with COPD who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist. It’s also the […]

Filed Under: Drug-Device Combinations, Pharmaceutical, Regulatory/Compliance, Respiratory, Wall Street Beat Tagged With: GlaxoSmithKline plc, Innoviva

Innoviva proposes $175m private placement

August 1, 2017 By Sarah Faulkner

Innoviva (NSDQ:INVA) said today that it plans to offer $175 million in a private placement to certain qualified institutional buyers. The Brisbane, Calif.-based company said it expects to give initial buyers a 30-day option to buy up to an additional $17.5 million in notes Get the full story at our sister site, Drug Delivery Business News.

Filed Under: Drug-Device Combinations, Funding Roundup, Pharmaceutical, Respiratory, Wall Street Beat Tagged With: Innoviva

Innoviva bows to pressure from Sarissa hedge fund, to review executive pay

April 14, 2017 By Brad Perriello

Innoviva (NSDQ:INVA) said yesterday that it plans to review its costs including the salaries of its top executive and board, bowing to pressure from hedge fund and activist investor Sarissa Capital Management. Two weeks ago the fund demanded that Innoviva cut CEO Michael Aguiar’s pay to less than $500,000 a year; Aguiar’s total compensation in 2015 […]

Filed Under: Drug-Device Combinations, Respiratory, Wall Street Beat Tagged With: GlaxoSmithKline plc, Innoviva, Sarissa Capital Management

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