According to Teva Pharmaceutical Industries, the FDA has approved 3 strengths each for the AirDuo RespiClick fluticasone propionate/salmeterol DPI and the ArmonAir RespiClick fluticasone propionate DPI for the treatment of asthma in patients aged 12 and older. Both the AirDuo RespiClick and the ArmonAir RespiClick are approved for twice daily use and both are expected … [Read more...] about FDA approves Teva’s AirDuo RespiClick and ArmonAir Respiclick inhalers
News
OptiNose appoints Keith A. Goldan as CFO
OptiNose has announced that Keith A. Goldan has joined the company as Chief Financial Officer. Goldan was most recently Senior VP and CFO of Fibrocell and previously served as CFO at NuPathe, PuriCore (now Realm Therapeutics), and Biosyn. The announcement comes a few months after the company announced the appointment of Tom Gibbs as Chief Commercial Officer. In … [Read more...] about OptiNose appoints Keith A. Goldan as CFO
FDA grants pediatric exclusivity for Symbicort
AstraZeneca has announced that the FDA had granted 6 months of pediatric exclusivity for its Symbicort budesonide/formoterol MDI based on trials in asthmatic children aged 6-12. In August 2016, AstraZeneca announced that its CHASE 3 (ChildHood Asthma Safety and Efficacy) study met its primary endpoint and that it planned to submit the data to the FDA The Symbicort … [Read more...] about FDA grants pediatric exclusivity for Symbicort
FDA approves lower dose formulation of Narcan nasal spray
Adapt Pharma announced that it has received FDA approval for a 2 mg dose version of Narcan naloxone nasal spray for the treatment of opioid overdose for opioid-addicted patients who would likely experience severe withdrawal if given the 4 mg dose. The 4 mg per dose formulation of Narcan was approved by the FDA in November 2015, and Adapt launched the nasal spray … [Read more...] about FDA approves lower dose formulation of Narcan nasal spray
ISAM’s plans for 2017 include 21st Congress in Santa Fe, NM
The International Society for Aerosols in Medicine (ISAM) has planned a number of activities for 2017 in line with its mission “to stimulate and further the interdisciplinary cooperation and exchange of information in all aspects of aerosol research in medicine including health effects of inhaled aerosols and pulmonary drug delivery,” including the society’s 21st … [Read more...] about ISAM’s plans for 2017 include 21st Congress in Santa Fe, NM
FDA approves IND for Vectura’s VR647 nebulized budesonide
According to Vectura, the FDA has approved the company's investigational new drug (IND) application for VR647 nebulized budesonide, which the company is developing for the treatment of asthma in children aged 12 months to 8 years. VR647 is delivered by the Akita Jet smart nebulizer, a technology that Vectura acquired in 2014, when it acquired Activaero. … [Read more...] about FDA approves IND for Vectura’s VR647 nebulized budesonide
Cipla launches the Synchrobreathe inhaler in South Africa
Cipla has launched its Synchrobreathe breath actuated inhaler in South Africa, the company announced. In 2015, Cipla had said that it expected to launch the inhaler by the end of that year. Cipla Medpro CEO Paul Miller said, “Incorrect use of inhalers and non-adherence to treatment are major contributors to the poor levels of asthma control we experience in South … [Read more...] about Cipla launches the Synchrobreathe inhaler in South Africa
NasoShield developer Altimmune to merge with PharmAthene
Altimmune, which is developing intranasal vaccines against influenza and anthrax, is set to merge with vaccine developer PharmAthene, the companies have announced. Altimmune will become a wholly-owned subsidiary of PharmAthene subject to stockholder approval of the all-stock transaction, and the combined company will operate under the name Altimmune. After years … [Read more...] about NasoShield developer Altimmune to merge with PharmAthene
Pulmatrix gets QIDP designation for PUR1900
According to Pulmatrix, its PUR1900 itraconazole DPI for the treatment of pulmonary aspergillus infections in cystic fibrosis patients has received Qualified Infectious Disease Product (QIDP) designation from the FDA. Pulmatrix CEO Robert Clarke commented, "The new QIDP designation is a significant boost to our efforts to make this drug available as quickly as … [Read more...] about Pulmatrix gets QIDP designation for PUR1900
Adherium appoints Scott Fleming as Senior VP of Business Development, Europe
Smartinhaler maker Adherium has announced the appointment of former MicroDose Therapeutx co-founder Scott Fleming as Senior VP of Business Development, Europe, effective immediately. Fleming replaces John Tarplee who left the company at the end of 2016 "to pursue a new venture." After the sale of MicroDose Therapeutx to Teva in 2013, Fleming served as Senior … [Read more...] about Adherium appoints Scott Fleming as Senior VP of Business Development, Europe