Insmed has announced the withdrawal of its marketing authorization application for Arikayce inhaled liposomal amikacin for the treatment of nontuberculous mycobacteria (NTM) lung disease. The MAA was submitted to the European Medicines Agency in 2014, prior to the beginning of a Phase 3 study. According to the company, the Committee for Medicinal Products for … [Read more...] about Insmed withdraws MAA for Arikayce for nontuberculous mycobacteria (NTM)
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Chiesi reports positive preliminary results from pivotal studies of triple combination MDI
Chiesi says that it is on track with planned regulatory submissions in the EU for its ICS/LAMA/LABA MDI for the treatment of COPD by the end of 2016 after successful completion of two 12-month Phase 3 studies. According to the company, preliminary results from the studies of the extrafine beclamethasone/formoterol/glycopyrronium combination therapy in more than 4,000 … [Read more...] about Chiesi reports positive preliminary results from pivotal studies of triple combination MDI
Hovione opens office in Japan
Spray-drying and DPI specialist Hovione announced the opening a new sales and customer support office in Osaka, Japan, saying that "The new office underlines the importance of Japan for Hovione's business activities. Japan is a strategic market for Hovione where the company is growing both its off patent API and its contract manufacturing businesses. The new office … [Read more...] about Hovione opens office in Japan
GSK to file NDA for FF/UMEC/VI combination by the end of 2016
GlaxoSmithKline plc (LSE:GSK) and Innoviva have announced that the planned submission of an NDA for a triple therapy DPI for the treatment of COPD has been moved up from the first half of 2018 to the end of 2016, following discussions with the FDA. The fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) combination is delivered using the Ellipta inhaler. The … [Read more...] about GSK to file NDA for FF/UMEC/VI combination by the end of 2016
Innovus Pharmaceuticals updates on plans for OTC FlutiCare nasal spray
California-based Innovus Pharmaceuticals announced that it has signed a manufacturing agreement for its FlutiCare fluticasone propionate nasal spray in anticipation of FDA approval, which it expects in the 3rd quarter of 2016. No details were revealed. The company acquired rights to the nasal spray in February 2015; an ANDA for the OTC version had been filed by … [Read more...] about Innovus Pharmaceuticals updates on plans for OTC FlutiCare nasal spray
Teva says DCP for Braltus tiotropium DPI results in “positive conclusion”
According to Teva Pharmaceutical, a decentralized procedure for its Braltus tiotropium bromide DPI for the treatment of COPD has reached "a positive conclusion." The tiotropium formulation is delivered using the new Zonda inhaler, the company said. No additional information was released other than the company's statement that "National Marketing Authorizations and … [Read more...] about Teva says DCP for Braltus tiotropium DPI results in “positive conclusion”
Perrigo and Hikma get FDA approval for and launch generic fluticasone propionate nasal spray
Perrigo and Hikma subsidiary West-Ward Pharmaceuticals have launched an OTC fluticasone propionate nasal spray, a generic version of Flonase, in the US after receiving approval for the product from the FDA, the companies said. The nasal spray will be marketed under store brand names. Flonase was approved for over-the-counter sales in the US in 2014. Hikma … [Read more...] about Perrigo and Hikma get FDA approval for and launch generic fluticasone propionate nasal spray
Pulmatrix completes PK study of PUR0200
Pulmatrix has announced the completion of a Phase 1 pharmacokinetic study of its PUR0200 generic tiotropium DPI in healthy volunteers. Pulmatrix announced the initiation of the study in February 2016. The company has partnered with Mylan on development of PUR0200, which it says is "is focused on demonstrating bioequivalence between PUR0200 and a currently marketed … [Read more...] about Pulmatrix completes PK study of PUR0200
Study shows superiority of Relvar (Breo) Ellipta to usual care in reducing COPD exacerbations
GlaxoSmithKline and Innoviva (formerly Theravance, Inc.) have announced data from the Salford Lung Study (SLS) showing that COPD patients using the Relvar Ellipta 100/25 mcg fluticasone furuoate/vilanterol DPI had an 8.41% lower rate of moderate or severe exacerbations compared to patients receiving LAMAs, LABAs, and/or ICS as monotherapy or in combination. Relvar … [Read more...] about Study shows superiority of Relvar (Breo) Ellipta to usual care in reducing COPD exacerbations
Vectura partners with Propeller Health to develop connected inhalers
Vectura Group and Propeller Health have announced that they will partner to develop a connected version of Vectura's LOMI (lever-operated multi-dose inhaler) DPI using Propeller's digital technology. The LOMI device, which is based on Vectura's GyroHaler, uses blister strips to deliver up to 60 doses. According to the announcement, discussions are underway to … [Read more...] about Vectura partners with Propeller Health to develop connected inhalers