Innovus Pharmaceuticals has announced that the acquisition of Novalere FP and its FlutiCare fluticasone propionate nasal spray. According to documents related to the merger filed with the US Securities and Exchange Commission (SEC), Novalere FP filed an ANDA for the product with the FDA in November 2014. The company says that it expects that the ANDA "may be approved … [Read more...] about Innovus Pharmaceuticals acquires fluticasone nasal spray
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AstraZeneca acquires Tudorza Pressair, other Actavis respiratory drugs in US and Canada
AstraZeneca will pay Actavis $600 million plus royalties for US and Canadian rights to Daliresp roflumilast and the Tudorza Pressair aclidinium bromide DPI, plus development rights to an aclidinium/formoterol DPI which was approved in Europe as Duaklir Genuair. AstraZeneca acquired Almirall's respiratory portfolio in 2014. Almirall had licensed US rights to … [Read more...] about AstraZeneca acquires Tudorza Pressair, other Actavis respiratory drugs in US and Canada
Ultribro Breezhaler now available in Quebec
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
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
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
Boehringer Ingelheim launches Spiriva Respimat in the US
Boehringer Ingelheim has announced that the Spiriva Respimat tiotropium soft mist inhaler is now available in the United States. Patients will also still be able to purchase Spiriva Handihaler, the company said. The FDA approved Spiriva Respimat for the treatment of COPD in September 2014. Boehringer Ingelheim Pharmaceuticals VP, Clinical Development & Medical … [Read more...] about Boehringer Ingelheim launches Spiriva Respimat in the US