According to Hikma Pharmaceuticals, the FDA has concluded the dispute resolution process regarding HIkma's ANDA for its generic version of the Advair fluticasone propionate/salmeterol DPI and has requested a new clinical study. The FDA issued a complete response letter to the ANDA in May 2017. The company affirmed that it "remains committed to bringing this … [Read more...] about FDA requests additional clinical trial for Hikma’s generic Advair
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Aradigm submits MAA for Linhaliq
Aradigm has submitted a marketing authorization application to the EMA for Linhaliq dual release inhaled ciprofloxacin for the treatment of chronic P. aeruginosa lung infections in non-cystic fibrosis bronchiectasis (NCFBE) patients, the company said. In January 2018, the FDA issued a CRL for Aradigm's NDA for Linhaliq. According to Aradigm, the MAA is supported by … [Read more...] about Aradigm submits MAA for Linhaliq
Label update for Relvar Ellipta approved by EC
A Type II variation application for the use of the Relvar Ellipta fluticasone furoate/vilanterol DPI in patients whose asthma is adequately controlled by an ICS/LABA combination has been approved by the EC, according to GSK and Innoviva. The application was submitted in July 2017, and the EMA's Committee for Medicinal Products for Human Use (CHMP) issued a … [Read more...] about Label update for Relvar Ellipta approved by EC
Hovione announces results of site inspections
CDMO Hovione has announced results from a total of 8 inspections at its manufacturing sites in 2017 as part of a new transparency effort. The report covers pre-approval, GMP, and surveillance inspections by regulators from the US, Russia, Japan, and the EU at sites in Portugal, Macau, and Ireland. Hovione recently announced the addition of commercial DPI capsule … [Read more...] about Hovione announces results of site inspections
Micro-Sphere announces successful GMP inspection of expanded facility
Swiss CDMO Micro-Sphere has announced the completion of a successful GMP inspection by Swissmedic of its facility in Lugano, Switzerland, which recently added to its spray drying and manufacturing capacity. Micro-Sphere offers a range of services for development and manufacturing of DPIs. In September 2017, the company announced that it had added a Harro Höfliger … [Read more...] about Micro-Sphere announces successful GMP inspection of expanded facility
MannKind initiates Phase 1 trial of Treprostinil Technosphere DPI for PAH
MannKind Corporation has announced the initiation of a Phase 1 clinical study of its dry powder formulation of treprostinil based on its Technosphere inhaled delivery technology for the treatment of pulmonary arterial hypertension (PAH). The company said that the Treprostinil Technosphere (TreT) study is being conducted under an IND filed with the FDA in January. … [Read more...] about MannKind initiates Phase 1 trial of Treprostinil Technosphere DPI for PAH
Copley Scientific joins IPAC-RS as an associate member
Inhaler testing equipment company Copley Scientific has joined the International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS) as an associate member, the company said. According to IPAC-RS, "A corporation is eligible for participation in IPAC-RS initiatives as an associate member if it develops or manufactures components and/or devices for … [Read more...] about Copley Scientific joins IPAC-RS as an associate member
Proveris Scientific spins off talking inhaler assistant technology to Uneva Health
OINDP testing specialist Proveris Scientific has spun off inhaler-specific talking guidance technology to a start up called Uneva Health, the company said. Uneva, which will be led by former Proveris President Sue Farina, is raising money for development of the SmartGuide Assistant platform, which verbally coaches the patient to properly perform each step of … [Read more...] about Proveris Scientific spins off talking inhaler assistant technology to Uneva Health
Ventolin, Seretide Diskus/Accuhalers recalled in multiple countries
Less than a week after GSK Canada said that it had recalled a lot of Ventolin Diskus in Canada due to “a manufacturing issue that may result in a small number of Ventolin Diskus devices not delivering the full number of doses in the device,” the MHRA announced a recall of 2 lots of Ventolin Accuhaler and 1 lot of Seretide Accuhaler in the UK due to the same issue. … [Read more...] about Ventolin, Seretide Diskus/Accuhalers recalled in multiple countries
Novi Systems launches DecaVision module for DecaVertus shake and fire system
Novi Systems has announced the launch of the DecaVision imaging module for its DecaVertus system, which can be configured for shake and fire testing of up to 10 pressurized metered dose inhalers at a time. The DecaVision module includes 10 cameras that photograph the dose counter of each device after each actuation, providing evidence to demonstrate that the … [Read more...] about Novi Systems launches DecaVision module for DecaVertus shake and fire system