According to Verona Pharma's mid-year update, the company is developing MDI and DPI formulations of its RPL554, an inhaled PDE3/PDE4 inhibitor. Nebulized RPL554 is currently in Phase 2 development, and Verona reported positive results from a Phase 2a trial of RPL554 for the treatment of acute exacerbations in COPD patients in March 2016. The company said that it … [Read more...] about Verona Pharma developing MDI and DPI formulations of RPL554
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Innovus Pharma preparing fo upcoming launch of FlutiCare nasal spray in US
Innovus Pharmaceuticals says that it has ordered 220,000 units of FlutiCare, an OTC fluticasone propionate nasal spray, in preparation for its US launch in the fourth quarter of 2017. The company says that it will launch a 120 spray version of the product for the treatment of allergic rhinitis. Innovus acquired the FlutiCare brand in 2015 when it acquired Novalere … [Read more...] about Innovus Pharma preparing fo upcoming launch of FlutiCare nasal spray in US
Chiesi’s triple combination Trimbow MDI approved in EU
The European Commission has approved Chiesi's Trimbow beclometasone dipropionate/formoterol fumarate/glycopyrronium bromide MDI for the treatment of COPD in patients for whom an ICS/LABA combination is insufficient to control symptoms and prevent exacerbations, the company said. The EMA’s Committee for Medicinal Products for Human Use (CHMP) had issued a positive … [Read more...] about Chiesi’s triple combination Trimbow MDI approved in EU
Astech Projects certified to ISO 9001:2015 standard
Laboratory automation company Astech Projects, which manufactures the Xelair, Xelize, and Xelox ranges of automated inhaler testing systems, has announced a recent transition to the ISO 9001:2015 revised international standard for Quality Management Systems (QMS). The company said, "By meeting the criteria, Astech have displayed strong leadership and management … [Read more...] about Astech Projects certified to ISO 9001:2015 standard
Lonza acquires Micro-Macinazione
Lonza has announced the acquisition of Swiss contract micronization company Micro-Macinazione. The company recently completed its acquisition of Capsugel which had acquired US micronization specialist Powdersize in 2015. Capsugel announced an expansion of its micronization capacity at the former Powdersize facility in Quakertown, PA in 2016, and that capacity came on … [Read more...] about Lonza acquires Micro-Macinazione
Teva’s QVAR RediHaler approved by the FDA
The FDA has approved 40μg and 80μg strengths of Teva's QVAR RediHaler beclomethasone dipropionate breath-actuated MDI for treatment of asthma in patients aged 4 and older, the company said. Teva said that it expects to launch the product in the US in the first quarter of 2018. The current version of QVAR, which added a dose counter, was approved by the FDA in 2014. … [Read more...] about Teva’s QVAR RediHaler approved by the FDA
Insmed’s inhaled liposomal amikacin gets established name
The FDA has designated the established name for Insmed's inhaled amikacin, which is in Phase 3 development for the treatment of nontuberculous mycobacteria (NTM) lung infections, as "amikacin liposome inhalation suspension," the company said in a business update. Insmed has previously called its amikacin suspension Arikayce and is now referring to the product as … [Read more...] about Insmed’s inhaled liposomal amikacin gets established name
Endo files suit against Lupin for infringement of Nascobal nasal spray patents
Endo Pharmaceuticals filed suit against Lupin on July 28, 2017 alleging infringement of patents related to Par's Nascobal cyanocobalamin nasal spray. The suit was filed in the United States District Court for the Eastern District of Texas and was assigned to Judge Rodney Gilstrap. The patents cited in the suit include US patents 7,229,636; 7,404,489; 7,879,349; … [Read more...] about Endo files suit against Lupin for infringement of Nascobal nasal spray patents
Milestone Pharmaceuticals raises $55 million for development of intranasal etripamil
Milestone Pharmaceuticals has raised $55 million in a Series C financing round led by Novo Holdings A/S, the company said. The company plans to use the money to fund Phase 3 clinical development of etripamil, an intranasal calcium channel antagonist for the treatment of paroxysmal supraventricular tachycardia (PSVT). Earlier this year, Milestone announced positive … [Read more...] about Milestone Pharmaceuticals raises $55 million for development of intranasal etripamil
Indivior’s Nalscue naloxone nasal spray approved in France
According to Indivior, the French regulatory agency Agence nationale de sécurité du médicament et des produits de santé (ANSM) has approved the company's MAA for Nalscue naloxone hydrochloride nasal spray for the reversal of opioid overdose. Nalscue had been available in France under a Temporary Authorization for Use since July 2016. Indivior Chief Medical Officer … [Read more...] about Indivior’s Nalscue naloxone nasal spray approved in France