Shares in Pulmatrix (NSDQ:PULM) fell last week even though the biopharmaceutical company beat expectations on Wall Street with its second quarter results. The Lexington, Mass.-based company posted a net loss of -$5.6 million with no revenue for the 3 months ended June 30, for bottom-line growth of 39% compared with the same period last year. Adjusted […]
Respiratory
Innoviva proposes $175m private placement
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. The terms of the convertible senior notes, which are due 2025, are […]
Mallinckrodt enrolls first infant in registry for inhaled nitric oxide gas
Mallinckrodt Pharmaceuticals (NYSE:MNK) said today that it included the first patient in its Phase IV registry evaluating the use of inhaled Inomax nitric oxide gas for premature neonates compared to term and near-term newborns. Inomax, which has FDA approval, is designed to boost oxygenation and lessen the need for extracorporeal membrane oxygenation in term and near-term […]
Samumed wins orphan drug status for inhaled IPF therapy
Samumed said today that the FDA awarded orphan drug status to its inhaled idiopathic pulmonary fibrosis therapy, SMo4646. The IPF therapy is administered using a nebulizer and can be used as a montherapy or in combination with pirfenidone or nintedanib, according to the San Diego-based company. “The FDA’s decision to grant an ODD to SM04646 […]
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 […]
Sunovion divests asthma, allergy tech to Covis Pharma
Sunovion Pharmaceuticals said today that it plans to divest the U.S. market rights for its allergy and asthma products to Covis Pharma, in an effort to narrow its focus to the company’s COPD portfolio. Included in the deal is Sunovion’s Alvesco inhalation aerosol, its Omnaris nasal spray and its Zetonna nasal aerosol. All three products […]
Synspira’s therapy could boost antibiotics against drug-resistant bacteria in CF patients
Privately-held Synspira touted a study today of its inhaled glycopolymer-based therapeutic with antibiotics as a potential treatment for pulmonary infection caused by the Burkholderia cepacia complex in patients with cystic fibrosis. The study was published in PLOS One. Synspira’s lead polycationic glycopolymer, SNSP113, was studied in combination with tobramycin and meropenem. These antibiotics, as well as ceftazidime, are often […]
Sunovion seeks FDA nod for COPD treatment – again
Sunovion Pharmaceuticals said today that the FDA accepted the revised new drug application for its eFlow chronic obstructive pulmonary disease drug-device combo. The submission follows a complete response letter that the FDA issued Sunovion in May. The Marlborough, Mass.-based company didn’t provide details as to why the FDA denied its initial application. The U.S. regulatory watchdog is […]
Windtree Therapeutics reports Phase II data for inhaled surfactant
Windtree Therapeutics (NSDQ:WINT) reported data today from the 221-patient Phase IIb trial of its aerosolized KL4 surfactant for the treatment of respiratory distress syndrome in premature infants. The Aerosurf trial evaluated aerosolized KL4 surfactant administered to premature infants 28 to 32 weeks gestational age in 2 dose groups with up to 2 repeat doses, compared […]
Synspira raises $8m for inhaled pulmonary therapies
Privately-held Synspira said today that raised $8 million from an unnamed private investor to bring its inhaled cystic fibrosis therapy into a Phase I safety study. The Boston-based company was founded earlier this year and is focused on developing inhaled therapies for pulmonary diseases, including cystic fibrosis, chronic obstructive pulmonary disease and pneumonia. Synspira holds […]