Hovione Technology, a subsidiary of CDMO Hovione, announced that it has been granted a patent on a new method of particle size analysis that provides improved sample preparation for more accurate measurements and better repeatability. Hovione Technology primarily focuses on dry powder inhaler devices, including the 8Shot large dose DPI, the TwinMax DPI, the Papillon … [Read more...] about Hovione Technology gets patent for new particle size analysis method
Products and Services
CDE activates DMF for Lindal’s KHFA metering valve
Lindal Group announced that the Chinese National Medical Product Administration's (NMPA) Center for Drug Evaluation (CDE) has listed the drug master file (DMF) for Lindal's 20 mm male MDI metering valve as active following review. The company said that "the inclusion of the KHFA valve marks significant progress in Lindal headway into the Chinese aerosol dispensing … [Read more...] about CDE activates DMF for Lindal’s KHFA metering valve
Noble launches “Human Factors Plus” service
Aptar Pharma subsidiary Noble has launched a suite of services for makers of combination products such as OINDPs under the "Human Factors Plus" (HF+) brand. Noble, which was acquired by Aptar Pharma in 2019, makes respiratory and intranasal training devices and patient onboarding platforms. The HF+ umbrella includes a number of services related to regulatory strategy, … [Read more...] about Noble launches “Human Factors Plus” service
BreatheSuite raises $1.2 million for continued development of inhaler monitoring systems
Canadian inhaler tracking and training start-up BreatheSuite has announced the completion of a $1.2 million financing round and said that it intends to use the funds for expanded distribution of its MDI add-on device in North America and for development of additional inhaler tracking products. The company conducted patient testing of its MDI add-on and associated app … [Read more...] about BreatheSuite raises $1.2 million for continued development of inhaler monitoring systems
Copley Scientific launches e-training on OINDP testing methods
Copley Scientific has announced the launch of an e-training service that allows customers to get live-streamed instruction in the use of OINDP testing equipment for in vitro testing. Both standard e-training packages and custom live-streamed instruction are available; topics include installation qualification and operational qualification (IQ/OQ) as well as … [Read more...] about Copley Scientific launches e-training on OINDP testing methods
Monash selects Iconovo’s ICOone DPI for its inhaled oxytocin for the prevention of postpartum hemorrhage
Swedish DPI developer Iconovo announced that Monash University has acquired exclusive global rights for the use of Iconovo's ICOone single dose DPI for delivery of Monash's inhaled oxytocin for the prevention of postpartum hemorrhage. The agreement includes €900,000 in milestone payments, as well as royalties paid for 20 years after launch of the product. Successful … [Read more...] about Monash selects Iconovo’s ICOone DPI for its inhaled oxytocin for the prevention of postpartum hemorrhage
Novan selects Catalent for development of intranasal berdazimer sodium
Catalent will supply development services for an intranasal formulation of Novan's berdazimer sodium for COVID-19, the companies said. Berdazimer sodium is a nitric oxide-releasing polymer based on Novan's Nitricil platform, and the company is developing topical gel formulations for the treatment of viral dermatological infections, including molluscum and genital … [Read more...] about Novan selects Catalent for development of intranasal berdazimer sodium
Vectura to add facility for development of highly potent inhaled drugs
CDMO Vectura, which specializes in inhaled drug development and manufacturing, announced that it is adding new product development capabilities for handling highly potent APIs. The new laboratory, which will be located at the company's Chippenham, UK facility, is expected to be ready for use in early 2021. The new lab will have six containment isolators to house … [Read more...] about Vectura to add facility for development of highly potent inhaled drugs
Berry launches RS01X connected DPI
Berry Global has announced the launch of the RS01X connected dry powder inhaler, a new version of its RS01 single dose DPI that integrates with Amiko's Respiro inhaler monitoring platform. The RS01X includes an integral battery and does not require charging, the company said. The Respiro platform, which received the CE mark for use with the Spiromax, Nexthaler, and … [Read more...] about Berry launches RS01X connected DPI
AireHealth gets 510(k) clearance for connected nebulizer
According to Florida-based startup AireHealth, the company has received 510(k) clearance from the FDA for its VitalMed connected portable vibrating mesh nebulizer. Earlier this year, AireHealth acquired BreathResearch and its VitalBreath virtual respiratory health monitoring platform. In 2021, the company said, the VitalMed nebulizer will connect to a new app called … [Read more...] about AireHealth gets 510(k) clearance for connected nebulizer