Health Canada has approved Teva Canada Limited's application for its tobramycin inhalation solution, a generic version of Novartis's TOBI inhalation solution for the treatment of P. aeruginosa infections in cystic fibrosis patients in Canada. The Teva tobramycin inhalation solution is now available in Canadian pharmacies, the company said. Teva Canada Limited … [Read more...] about Teva Canada launches tobramycin inhalation solution
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Aptar Pharma teams with Propeller Health on connected MDI
Propeller Health and Aptar Pharma have teamed up to develop a connected MDI that features an integrated sensor and an electronic dose counter. The companies say that they expect to begin clinical studies with the inhaler by the end of 2016 and that they are looking to license the device. The Propeller inhaler tracking platform has received 510(k) clearance from … [Read more...] about Aptar Pharma teams with Propeller Health on connected MDI
Astech Projects acquired by Schauenburg International Group
Laboratory automation company Astech Projects has been acquired by German holding company the Schauenburg International Group. Astech Projects manufactures the Xelair, Xelize, and Xelox ranges of automated inhaler testing systems and offers systems for nasal spray and blister strip testing as well. According to the announcement, all of the management and … [Read more...] about Astech Projects acquired by Schauenburg International Group
FDA accepting comments on draft guidances for rhinitis drug development
The FDA published notices on February 16, 2016 announcing publication of draft guidances titled “Allergic Rhinitis: Developing Drug Products for Treatment” and "Nonallergic Rhinitis: Developing Drug Products for Treatment. The agency says that comments should be submitted by April 18, 2016 for either draft guidance in order to be considered prior to the start of work … [Read more...] about FDA accepting comments on draft guidances for rhinitis drug development
FDA approval for Lannett’s generic version of Imitrex nasal spray
Lannett Company has received FDA approval for its sumatriptan nasal spray, a generic version of GSK's Imitrex nasal spray. The company cites IMS statistics showing that US sales of sumatriptan nasal spray totaled $62 million in 2015. Lannett CEO Arthur Bedrosian commented, "We believe our sumatriptan nasal spray USP, 5 mg/spray and 20 mg/spray will be a … [Read more...] about FDA approval for Lannett’s generic version of Imitrex nasal spray
GDUFA date for Mylan’s generic Advair set for March 2017
The FDA has accepted Mylan's abbreviated new drug application for its generic fluticasone propionate/salmeterol DPI and has set a GDUFA goal date of March 28, 2017, the company said. Mylan filed the ANDA for the generic version of GSK's Advair Diskus in January 2016. Mylan CEO Heather Bresch commented, "The FDA's acceptance of our ANDA filing is an important … [Read more...] about GDUFA date for Mylan’s generic Advair set for March 2017
Kent Kresa takes over as MannKind’s Chairman of the Board
MannKind Corporation has announced the resignation of Alfred Mann as Executive Chairman and the appointment of Kent Kresa as Chairman of the Board, effective immediately. Mann will continue as a non-executive advisor, the company said. Kresa is Chairman Emeritus of Northrop Grumman Corporation and has served on the boards of numerous companies, universities, and … [Read more...] about Kent Kresa takes over as MannKind’s Chairman of the Board
Japanese authorities approve Phase 2/3 trial of inhaled molgramostim
Serendex Pharmaceuticals has announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has approved the company's planned IMPALA Phase 2/3 clinical trial of Molgradex inhaled molgramostim for pulmonary alveolar proteinosis (PAP). According to the company, the trial has already been approved in Denmark and the Netherlands, and will also include … [Read more...] about Japanese authorities approve Phase 2/3 trial of inhaled molgramostim
Capsugel teams up with Pulmatrix on DPI development
Capsugel and Pulmatrix have announced an agreement for development of new inhaled therapies based on the spray drying and manufacturing expertise at Capsugel's Bend Research subsidiary combined with Pulmatrix's iSPERSE dry powder technology. Bend Research Head of Alliance Strategy Dan Dobry commented, “This strategic partnership with Pulmatrix puts our companies … [Read more...] about Capsugel teams up with Pulmatrix on DPI development
Positive Phase 2b results for Ockham’s inhaled heparin for COPD
UK-based Ockham Biotech has announced that data from a Phase 2b study of its inhaled heparin for the treatment of COPD demonstrate significant improvement in lung function compared to placebo, with improvements maintained for 7 days after cessation of treatment and no adverse events. The study involved 24 moderate-to-severe COPD patients who received either … [Read more...] about Positive Phase 2b results for Ockham’s inhaled heparin for COPD