Theravance Biopharma‘s (NSDQ:TBPH) said today that the FDA granted expanded indications for GlaxoSmithKline‘s (NYSE:GSK) Trelegy Ellipta inhaler, now approved for use to treat a broader population of chronic obstructive pulmonary disease patients. With the expansion, the inhaler is now cleared for COPD patients with airflow limitations and for those who have experienced an acute worsening of […]
Theravance Biopharma
FDA to review Theravance’s application for once-daily COPD med
The FDA has accepted Theravance Biopharma‘s (NSDQ:TBPH) marketing application for revefenacin, an inhaled long-acting muscarinic antagonist designed to treat chronic obstructive pulmonary disease. The FDA is slated to make a decision about the once-daily treatment by Nov. 13. “The acceptance of our NDA moves us closer to providing COPD patients with access to once-daily, nebulized […]
Mylan, Theravance’s inhaled COPD therapy proves safe in late-stage trial
Mylan (NSDQ:MYL) and Theravance Biopharma, Inc. (NSDQ:TBPH) touted safety data yesterday from the late-stage trial of its once-daily inhaled bronchodilator, revefenacin, in patients with chronic obstructive pulmonary disease. If approved, revefenacin would be the first nebulized long-acting muscarinic antagonist on the market for COPD patients in the U.S. Revefenacin was generally well-tolerated among the 1,055 patients who participated in the […]
ATS Roundup: Emulate models viral infection in “asthma-on-a-chip”
Emulate‘s small airway-lung chip could help researchers study viral-induced exacerbations of asthma, according to data presented this week at the American Thoracic Society’s annual meeting. The studies were conducted as part of the company’s partnership with (NYSE:MRK). The collaborative project was designed to enable development of new anti-inflammatory treatments for patients with asthma, according to Emulate. […]
Mylan, Theravance touts Phase III data for COPD drug
Mylan (NSDQ:MYL) and Theravance Biopharma, Inc. (NSDQ:TBPH) said today that revefenacin, the 1st nebulized bronchodilator in development for the treatment of chronic obstructive pulmonary disease, demonstrated positive results in 2 replicate phase III efficacy studies. Data from more than 1,250 moderate to severe COPD patients showed that both studies met their efficacy and safety endpoints. Revefenacin […]
