Theravance Biopharma and Mylan have announced that the NDA for revefenacin (TD-4208) inhalation solution for the treatment of COPD the companies submitted in November 2017 has been accepted for review by the FDA, with a PDUFA target date of November 13, 2018. According to the companies, the agency has said that it is not currently planning to have an advisory … [Read more...] about FDA accepts revefenacin NDA for review
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Aradigm receives CRL for Linhaliq
Aradigm Corporation has received a complete response letter from the FDA in response to its NDA for Linhaliq dual release inhaled ciprofloxacinfor the treatment of P. aeruginosa infections in non-cystic fibrosis bronchiectasis (NCFBE) patients, the company said. An FDA advisory committee recently voted against recommending approval of the application. According to … [Read more...] about Aradigm receives CRL for Linhaliq
CHMP adopts positive opinion on Relvar Ellipta for additional indication
According to GlaxoSmithKline and Innoviva, the EMA's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding approval of the Relvar Ellipta fluticasone furoate/vilanterol DPI for the treatment of asthma that is adequately controlled with an inhaled corticosteroid and a LABA. The companies said that they expect to get the final … [Read more...] about CHMP adopts positive opinion on Relvar Ellipta for additional indication
Liquidia announces positive results from Phase 1 trial of LIQ861 trepostinil DPI
Liquidia Technologies has presented preclinical and Phase 1 study results for its LIQ861 inhaled treprostinil for the treatment of pulmonary arterial hypertension at the Annual World Congress of the Pulmonary Vascular Research Institute (PVRI), noting that the data supported advancement of LIQ861 into the INSPIRE Phase 3 trial which was initiated earlier this month. … [Read more...] about Liquidia announces positive results from Phase 1 trial of LIQ861 trepostinil DPI
Hovione adds DPI capsule filling capacity
Hovione has announced the addition of a new MG2 Tekna capsule filler for filling DPI capsules at the company's Loures, Portugal facilities. The MG2 Tekna machine, which has a capacity of up to 110,000 capsules/hour with 100% fill weight check, can be used for filling highly potent compounds. The company said in the announcement, "This investment reinforces … [Read more...] about Hovione adds DPI capsule filling capacity
Iceland approves Penthrox inhaled methoxyflurane
The Icelandic Medicines Agency has approved an MAA filed by Medical Developments International (MVP) to allow marketing of Penthrox inhaled methoxyflurane for the treatment of pain due to traumatic injury. The company said that Penthrox would be available for sale in Iceland immediately after the approval, which was dated January 16, 2018. In December 2017, MVP … [Read more...] about Iceland approves Penthrox inhaled methoxyflurane
Pulmatrix announces Phase 1/1b study of Pulmazole inhaled intraconazole
The UK Medicines and Healthcare Products Regulatory Agency has approved a Clinical Trial Application filed by Pulmatrix for a Phase 1/1b study of Pulmazole (PUR1900) inhaled dry powder itraconazole for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in asthma patients, the company said. In October 2017, Pulmatrix announced that PUR1900 received … [Read more...] about Pulmatrix announces Phase 1/1b study of Pulmazole inhaled intraconazole
Adherium opens new corporate headquarters in US
Smartinhaler maker Adherium has opened a new corporate headquarters in San Mateo, California, the company said. In 2017, the company announced that it had sold more than 100,000 Smartinhaler inhaler monitoring systems. Adherium CEO Arik Anderson commented, “Our headquarters at 1800 Gateway Drive deepens our existing footprint in Silicon Valley, as we take the … [Read more...] about Adherium opens new corporate headquarters in US
Copley Scientific launches new Breath Actuation Controller for MDI testing
Copley Scientific has announced the launch of the BAC 2100 Breath Actuation Controller for automated flow control during cascade impaction and delivered dose uniformity testing of metered dose inhalers. The company is also launching the BAC 2100-R, with reversed flow inlet and outlets. The new versions of the BAC include automated cascade impactor leak testing, an … [Read more...] about Copley Scientific launches new Breath Actuation Controller for MDI testing
Roger Jeffs joins board of Spyryx Biosciences
Spyryx Biosciences, which recently initiated a Phase 2 study of its SPX-101 inhaled SPLUNC1-derived peptide for the treatment of cystic fibrosis, announced that former United Therapeutics CEO Roger Jeffs has joined its board of directors. Jeffs served as President and COO of United Therapeutics from 1998-2014 and as President and CEO from January 2015 until mid … [Read more...] about Roger Jeffs joins board of Spyryx Biosciences