In advertisements appearing in British nursing, pharmaceutical, and medical journals.the Prescription Medicines Code of Practice Authority (PMCPA), the administrator of the Association of the British Pharmaceutical Industry’s (ABPI) Code of Practice for the Pharmaceutical Industry, has called out AstraZeneca for misleading promotions of the Duaklir Genuair … [Read more...] about PMCPA accuses AstraZeneca of being misleading about Duaklir Genuair indications
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Sunovion gets US rights to Utibron, Seebri, and Arcapta Neohalers
Sunovion has acquired exclusive US marketing rights to three Novartis DPIs for the treatment of COPD, the company has announced. The company said that it plans to market the Utibron (indacaterol/glycopyrrolate) Neohaler, Seebri (glycopyrrolate) Neohaler, and Arcapta (indacaterol) Neohaler beginning in 2017. Novartis will continue to manufacture the three … [Read more...] about Sunovion gets US rights to Utibron, Seebri, and Arcapta Neohalers
Evoke Pharma reports positive pre-NDA meeting with FDA for intranasal metoclopramide
Evoke Pharma says that it recently had a positive pre-NDA meeting with the FDA regarding clinical data to be included in its planned 505(b)(2) NDA for Gimoti intranasal metoclopramide for the treatment of diabetic gastroparesis in adult women. The meeting was the second regarding Gimoti. After the first meeting, Evoke announced that it planned to move ahead with … [Read more...] about Evoke Pharma reports positive pre-NDA meeting with FDA for intranasal metoclopramide
GSK initiates Phase 3 study of triple therapy DPI for the treatment of asthma
GlaxoSmithKline and Innoviva have announced the initiation of a Phase 3 study of a fluticasone furoate/umeclidinium/vilanterol DPI compared to Relvar/Breo Ellipta for the treatment of asthma. GSK recently filed regulatory submissions for the FF/UMEC/VI DPI for the treatment of COPD in the United States and in the European Union. The Clinical study of Asthma … [Read more...] about GSK initiates Phase 3 study of triple therapy DPI for the treatment of asthma
DDL 27 showcased new technologies and targets for inhaled drugs
While acknowledging the 60th anniversary of the metered dose inhaler, the 27th annual Drug Delivery to the Lungs meeting devoted much of its program to looking forward beyond conventional devices, formulations, and targets. More than 700 delegates to DDL 27, held December 7-9 at the Edinburgh International Conference Center, heard presentations focused on the use of … [Read more...] about DDL 27 showcased new technologies and targets for inhaled drugs
Capsugel to be acquired by Lonza
Lonza Group will acquire capsule manufacturer and CDMO Capsugel from KKR for $5.5 billion, the company has announced. The deal has been approved by the boards of both companies and is expected to close by mid-2017. KKR acquired Capsugel from Pfizer in 2011 for a little less than $2.4 billion. Capsugel manufactures capsules for DPIs and offers development and … [Read more...] about Capsugel to be acquired by Lonza
Startup Cephalgia gets funding from University of Chicago Innovation Fund for intranasal IGF-1
Cephalgia, a startup spun out of the University of Chicago, will receive $250,000 from the university's Innovation Fund for development of intranasal IGF-1 for the treatment of migraine, according to the fund. The company was selected to receive the money after pitching its business plan in a live competition. University of Chicago Associate VP for Entrepreneurship … [Read more...] about Startup Cephalgia gets funding from University of Chicago Innovation Fund for intranasal IGF-1
Propeller Health platform will integrate with MIR spirometers
Propeller Health has announced that its inhaler monitoring platform will integrate with mobile and clinical spirometers from Medical International Research (MIR). According to Propeller, its platform "is the only commercially marketed respiratory digital health solution to include FDA cleared inhaler sensors, digital interfaces and truly mobile spirometers." … [Read more...] about Propeller Health platform will integrate with MIR spirometers
Adherium’s Smartinhaler platform selected for myAirCoach
Adherium has announced that its Smartinhaler has been selected for use in the myAirCoach project, which will study the effectiveness of mHealth systems for asthma control. The program, which includes participation by Imperial College London, the University of Manchester, and Leiden University Medical Center, is funded through the European Commission's Horizon 2020 … [Read more...] about Adherium’s Smartinhaler platform selected for myAirCoach
Mexichem discusses potential for using HFA 152a as pMDI propellant
Following the signing of an international phase-down agreement regarding fluorinated gases in October 2016, pMDI propellent supplier Mexichem stated that it "does not believe the recent Kigali Amendment to the Montreal Protocol, nor regulatory controls such as the European F-Gas Regulation or US SNAP, will affect the availability of HFA medical propellants in the … [Read more...] about Mexichem discusses potential for using HFA 152a as pMDI propellant