Researchers at the 47th Society of Critical Care Medicine reported this week that Hill-Rom‘s (NYSE:HRC) Metaneb System may help reduce the incidence of post-operative pulmonary complications in high-risk patients. A 419-patient study found that patients using the Metaneb System combined with standard respiratory therapy spent 1.6 fewer days in the hospital on average compared to […]
Respiratory
Pieris Pharmaceuticals closes $51m public offering
Pieris Pharmaceuticals (NSDQ:PIRS) has closed an underwritten public offering of 6,325,000 shares of its common stock. The Boston, Mass.-based company said it reeled in $50.6 million from the offering, which it plans to use to fund the pre-clinical and clinical development of its pipeline. In May last year, Pieris inked a $45 million deal with AstraZeneca (NYSE:AZN) to develop a group […]
Acorda Therapeutics wins FDA NDA nod for Inbrija
Acorda Therapeutics (NSDQ:ACOR) said today that the FDA accepted the New Drug Application for its Inbrija investigational inhaled levodopa product designed for treating symptoms of OFF periods in patients with Parkinson’s disease who are taking carbidopa/levodopa regimens. The approval comes with a target date of October 5, 2018, the Ardsley, N.Y.-based company said. The NDA comes supported […]
GSK seeks expanded label for Trelegy Ellipta inhaler in EU
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 […]
Pulmatrix doses first patient in Ph1 Pulmazole trial
Pulmatrix (NSDQ:PULM) said today that the first patient was treated in a first-in-human study of Pulmazole – an inhaled formulation of the anti-fungal drug, itraconazole. The Lexington, Mass.-based company is evaluating its iSperse formulation of the drug as a treatment for asthma patients who have developed allergic bronchopulmonary aspergillosis. Patients with ABPA are usually given oral […]
Teva launches breath-activated asthma aerosol in U.S.
Teva Pharmaceuticals (NYSE:TEVA) has launched its Qvar RediHaler inhalation aerosol in the U.S., marking the first time a breath-actuated inhaled corticosteroid is available for asthma patients as a prophylactic therapy. In contrast to traditional metered-dose inhalers, Teva’s Qvar RediHaler sends medication into the user’s lungs as they inhale. This feature eliminates the need for hand-breath coordination, […]
Innoviva posts Street-beating Q4, FY17 earnings
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 […]
FDA rejects Novartis’ Advair generic, leaving GSK without rival
GlaxoSmithKline (NYSE:GSK) was granted a temporary win today after Novartis‘ (NYSE:NVS) Sandoz unit reported that the FDA rejected its application for a generic version of the company’s blockbuster lung treatment, Advair. The regulatory agency reportedly told Novartis that it needs to submit additional clinical data before the FDA can make its final decision. GSK said in […]
Amiko wins CE Mark to integrate drug sensor tech into inhalers
Amiko Digital Health said today that it received CE Mark clearance to integrate its Respiro medication sensor tech with Teva Pharmaceuticals‘ (NYSE:TEVA) Spiromax inhaler, Chiesi‘s Nexthaler device and GlaxoSmithKline‘s (NYSE:GSK) Ellipta inhaler. The company’s Respiro platform is designed to help doctors monitor, in real-time, when and how well patients are using their medications. “Respiro’s medication […]
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 […]