Novartis Pharmaceuticals Canada has announced the launch of the Ultibro Breezhaler indacaterol/glycopyrronium bromide DPI for the treatment of COPD in Quebec, the first province in Canada to reimburse the inhaler. The Régie de l’assurance maladie du Québec (RAMQ), which administers prescription drug insurance plans, has listed Ultribro Breezhaler as a “Médicament … [Read more...] about Ultribro Breezhaler now available in Quebec
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Patient dosing begins in Phase 2a studies of AIR001 for the treatment of heart failure
Mast Therapeutics has announced that the first patients have been dosed in two Phase 2a studies of AIR001 sodium nitrite inhalation solution for the treatment of patients with heart failure with preserved ejection fraction (HFpEF). A third Phase 2a study is due to start later this year. Mast acquired AIR001, which was being developed as a treatment for pulmonary … [Read more...] about Patient dosing begins in Phase 2a studies of AIR001 for the treatment of heart failure
Chris Blackwell to step down as Vectura Chief Executive
Vectura Chief Executive Chris Blackwell will step down from that position at the end of June 2015, the company has announced. Blackwell has been with the company since 2002. The company's board says that it plans a search for a new chief executive. Vectura licenses its DPI devices and formulations to numerous pharmaceutical companies, most recently announcing a … [Read more...] about Chris Blackwell to step down as Vectura Chief Executive
Sanofi and Mannkind launch Afrezza in the US
Afrezza inhaled insulin is now available by prescription in the US, Sanofi and Mannkind Corporation have announced. The FDA approved the insulin DPI for the treatment of type 1 and type 2 diabetes in June 2014. In August 2014, Sanofi announced that it would pay Mannkind $150 million upfront and milestone payments of up to $775 million for an exclusive license for the … [Read more...] about Sanofi and Mannkind launch Afrezza in the US
Evoke Pharma’s intranasal metoclopramide program delayed
Evoke Pharma has announced that slower than expected enrollment in a Phase 3 clinical trial of its EVK-001 metoclopramide nasal spray for the treatment of diabetic gastroparesis in women will result in delayed completion of the development program and potential NDA submission. The company says that it now expects enrollment to be complete in the second half of 2015 … [Read more...] about Evoke Pharma’s intranasal metoclopramide program delayed
Theravance Biopharma and Mylan to partner on TD-4208
Theravance Biopharma and Mylan announced that they have entered into a development and commercialization agreement for TD-4208, a novel nebulized LAMA for the treatment of COPD and other respiratory diseases that is currently in Phase 2 development. Theravance Biopharma will retain the rights to MDI and DPI formulations of the drug. As part of the deal Mylan will … [Read more...] about Theravance Biopharma and Mylan to partner on TD-4208
Adamis gets US and Japanese patents for Taper DPI
Adamis Pharmaceuticals has announced that the US and Japanese patent offices have approved applications for patents related to the Taper dry powder inhaler, an API-only device that was developed initially by 3M Drug Delivery Systems. Adamis acquired the device from 3M DDS in 2013. US Patent Application No. 13/320,762 and Japanese Patent Application No. 2012-511965, … [Read more...] about Adamis gets US and Japanese patents for Taper DPI
Study finds that use of triamcinolone nasal spray affects children’s growth
A study published online in Pediatrics finds that children using a triamcinolone nasal spray for allergic rhinitis grew on average 0.44 cm/year less than children using a placebo nasal spray (5.65 cm/year compared to 6.09 cm/year). The year-long study was conducted according to the 2007 FDA guidance on Orally Inhaled and Intranasal Corticosteroids: Evaluation of the … [Read more...] about Study finds that use of triamcinolone nasal spray affects children’s growth
GSK launches Arnuity Ellipta and Incruse Ellipta in the US
GlaxoSmithKline has announced that both the Arnuity Ellipta fluticasone furoate DPI and the Incruse Ellipta umeclidinium bromide DPI are now available in the US. Arnuity Ellipta was approved by the FDA in August 2014 for the treatment of asthma. The FDA approved Incruse Ellipta for the treatment of COPD in April 2014. GSK Senior VP of the US Respiratory Business … [Read more...] about GSK launches Arnuity Ellipta and Incruse Ellipta in the US
PARI’s eRapid nebulizer now approved for delivery of Pulmozyme in US
PARI has announced that following approval by the FDA, its eRapid nebulizer is now available for delivery of Pulmozyme dornase alfa inhalation solution for the treatment of cystic fibrosis. In Europe, the device, marketed as eFlow Rapid, has been available for use with Pulmozyme for years. The eRapid nebulizer cuts Pulmozyme delivery time to 2-3 minutes compared … [Read more...] about PARI’s eRapid nebulizer now approved for delivery of Pulmozyme in US