GSK and Innoviva have announced that an NDA for the Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol DPI for the treatment of COPD has been submitted to the Japanese Ministry of Health, Labour and Welfare (MHLW). Trelegy Ellipta was approved in the US and in Europe for the treatment of COPD in 2017 and was approved in Canada earlier this year. The FDA … [Read more...] about GSK submits marketing application for Trelegy Ellipta in Japan
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Dry powder nitric oxide release formulation reduces bacterial load of NTM by 99% in preclinical study
Vast Therapeutics, which recently changed its name from Novoclem Therapeutics, has announced that its BIOC51 dry powder nitric oxide (NO)-release formulation reduced the bacterial load of nontuberculous mycobacteria (NTM) in the lungs of mice by 99% in a study conducted with Colorado State University. According to the company, BIOC51 has eradicated every bacterial … [Read more...] about Dry powder nitric oxide release formulation reduces bacterial load of NTM by 99% in preclinical study
Windtree Therapeutics gets $700,000 for follow-up to Phase 2b Aerosurf study
Windtree Therapeutics has received the remaining $700,000 from a Small Business Innovation Research Grant (SBIR) from the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) that was initially awarded in 2016 for Phase 2 development of Aerosurf. The company previously received a total of $1.9 million from that award, an … [Read more...] about Windtree Therapeutics gets $700,000 for follow-up to Phase 2b Aerosurf study
Sava Healthcare gets Russian GMP approval for Indian DPI capsule manufacturing line
Indian pharma company Sava Healthcare has announced that its DPI capsule manufacturing line has received approval from the Russian Ministry of Health (MOH). Sava said that it manufactures tiotropium, formoterol, salmeterol/fluticasone, and budesonide/formoterol DPIs for the Russian and CIS markets. According to Sava, its Surendranagar facility, which also … [Read more...] about Sava Healthcare gets Russian GMP approval for Indian DPI capsule manufacturing line
Glenmark submits NDA for Ryaltris nasal spray
Glenmark Pharmaceuticals has submitted an NDA for Ryaltris olopatadine hydrochloride/mometasone furoate nasal spray for the treatment of seasonal allergic rhinitis in patients aged 12 and older, the company said. In December 2017, the company announced that a Phase 3 trial of Ryaltris (GSP 301) had met its primary endpoint. Glenmark Pharmaceuticals President … [Read more...] about Glenmark submits NDA for Ryaltris nasal spray
FDA approves Arnuity Ellipta for pediatric use
According to GSK, the FDA has approved the company's sNDA for the use of Arnuity Ellipta fluticasone furoate DPI for the treatment of asthma in children aged 5-11 years. Arnuity Ellipta was approved by the FDA in 2014 for the treatment of asthma in patients 12 years old and older. GSK submitted the sNDA for pediatric use in July 2017. The new approval is for a … [Read more...] about FDA approves Arnuity Ellipta for pediatric use
Galecto Biotech names Richard Marshall as Chief Medical Officer
Galecto Biotech, which is developing an inhaled galectin-3 inhibitor for the treatment of idiopathic pulmonary fibrosis (IPF), has hired former GSK VP and Head of the Fibrosis & Lung Injury Discovery Performance Unit Richard Marshall as its Chief Medical Officer, the company said. Marshall held a number of positions in respiratory drug development at GSK over 15 … [Read more...] about Galecto Biotech names Richard Marshall as Chief Medical Officer
Adherium rebrands Smartinhaler as “Hailie”
Inhaler monitoring company Adherium has announced that its Smartinhaler platform has been rebranded as "Hailie." The rebranding includes includes the Hailie asthma and COPD tracking app and Hailie sensors, which will soon launch in the US. Earlier this year, the FDA granted 510(k) OTC clearance for the Smartinhaler SmartTouch sensor for use with Symbicort. The … [Read more...] about Adherium rebrands Smartinhaler as “Hailie”
Liquidia Technologies appoints Jeri Thomas Senior VP, Commercial
Liquidia Technologies has named Jeri Thomas as its new Senior VP Commercial, responsible initially for commercial plans for the company's LIQ861 treprostinil DPI, which is currently in Phase 3 development for the treatment of pulmonary arterial hypertension (PAH). According to Liquidia, Thomas was most recently Senior VP, Strategic Group Planning at healthcare … [Read more...] about Liquidia Technologies appoints Jeri Thomas Senior VP, Commercial
Insmed’s NDA for ALIS accepted by the FDA
The FDA has accepted Insned's NDA for ALIS (amikacin liposome inhalation suspension) for the treatment of nontuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC), with a PDUFA date of September 28, 2018, the company said. Insmed announced submission of the NDA in March 2018. Insmed President and CEO Will Lewis commented, "We … [Read more...] about Insmed’s NDA for ALIS accepted by the FDA