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
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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
Study shows improved cardiac function for COPD patients using Ultibro Breezhaler
Results from the CLAIM study published online in Lancet Respiratory Medicine on February 21, 2018 show that COPD patients using Novartis's Ultibro Breezhalerindacaterol/glycopyrronium DPI had significantly decreased lung hyperinflation and improved cardiac function after 14 days compared to placebo. Ultibro Breezhaler has been approved for the treatment of COPD in … [Read more...] about Study shows improved cardiac function for COPD patients using Ultibro Breezhaler
HCmed partners with Pharos to market the Deepro vibrating mesh nebulizer in Indonesia
HCmed has announced that a partnership with pharmaceutical company Pharos Indonesia has led to approval for its Deepro vibrating mesh nebulizer from the Indonesian National Drug and Food Control Agency (BPOM), and the companies will now launch the Deepro device in Indonesia. Earlier this year, HCmed announced that it had received a strategic investment from Vivo … [Read more...] about HCmed partners with Pharos to market the Deepro vibrating mesh nebulizer in Indonesia
FluMist Quadrivalent intranasal flu vaccine gets renewed recommendation
AstraZeneca has announced that the US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) has voted to recommend the use of FluMist Quadrivalent intranasal live Influenza vaccine for the 2018-19 flu season based on positive results of a new study in children aged 2-4 years old. FluMist Quadrivalent was approved by the … [Read more...] about FluMist Quadrivalent intranasal flu vaccine gets renewed recommendation
Lonza announces addition of DPI capsule filling capabilities
Lonza has announced the installation of a new Harro Hӧfliger Modu-C MS encapsulation unit at its product development and manufacturing facility in Tampa, FL. The company said that installation and validation of the unit are expected to be complete by the end of the month. Lonza also said that it expects to open a new dispensing area and processing suites for highly … [Read more...] about Lonza announces addition of DPI capsule filling capabilities