Allergan, which recently acquired MAP Pharmaceuticals, has announced that it has received a Complete Response Letter (CRL) from the FDA in regard to its NDA for Levadex inhaled dihydroergotamine for the treatment of migraines. The company also announced that it has acquired CMO Exemplar, which had previously received a form 483 for problems with Levadex … [Read more...] about Allergan acquires Exemplar, gets Complete Response Letter for Levadex
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Positive Phase 3 results for Almirall and Forest’s aclidinium/formoterol DPI
Almirall and Forest Laboratories have announced that a 6-month Phase 3 study of their aclidinium bromide/formoterol fumarate dry powder fixed dose combination delivered by the Genuair (Pressair) inhaler for the treatment of COPD demonstrated statistically significant improvements with both doses tested. The study of more than 1,700 patients found that both the … [Read more...] about Positive Phase 3 results for Almirall and Forest’s aclidinium/formoterol DPI
Phase 3 trial of Amikacin Inhale gets underway
Bayer HealthCare has announced the initiation of its Phase 3 program to evaluate the efficacy and safety of Amikacin Inhale in patients with Gram-negative pneumonia who are intubated and mechanically ventilated and being treated with intravenous antibiotics. Bayer is developing Amikacin Inhale in partnership with Nektar, and the inhalation solution is delivered by … [Read more...] about Phase 3 trial of Amikacin Inhale gets underway
Discovery Labs says Aerosurf program “currently remains on track”
According to Discovery Laboratories its Aerosurf aerosolized surfactant development program "currently remains on track for the Phase 2 clinical program in the fourth quarter of 2013" and is unaffected by the FDA's recent questions about product specifications for Discovery Labs' Surfaxin intratracheal suspension surfactant. The company says that it will respond to … [Read more...] about Discovery Labs says Aerosurf program “currently remains on track”
Asmacure initiates Phase 1/2 trial of ASM-024 DPI
Canadian respiratory drug developer Asmacure has dosed the first subjects in a Phase 1/2 clinical trial of its ASM-024 inhalation powder for the treatment of asthma, the company says. According to the company, "ASM-024 has a novel multi-functional mechanism of action with nicotinic and muscarinic effects and has demonstrated anti-inflammatory effects, … [Read more...] about Asmacure initiates Phase 1/2 trial of ASM-024 DPI
Positive Phase 2 results for Activaero budesonide delivery study
According to Activaero, a Phase 2 trial of a budesonide suspension delivered using its FAVORITE (Flow and Volume Controlled Inhalation Technology) system in children with mild to moderate asthma improved asthma control, reduced treatment times, and required lower doses of the drug. In the proof-of-concept study, 41 German children aged 3 to 11 with mild to moderate … [Read more...] about Positive Phase 2 results for Activaero budesonide delivery study
FDA draft guidance on albuterol MDI bioequivalence includes recommendations for in vivo and in vitro studies
The FDA draft guidance on albuterol sulfate MDIs published April 8, 2013 includes recommendations for a total of 7 studies, including 5 in vitro studies, 1 PK study, and 1 PD study to establish bioequivalence. The recommendations for in vitro testing cover single actuation content, aerodynamic particle size distribution (APSD), spray pattern, plume geometry, and … [Read more...] about FDA draft guidance on albuterol MDI bioequivalence includes recommendations for in vivo and in vitro studies
Beximco announces board changes
Bangladeshi pharmaceutical company Beximco Pharma has announced the resignation of Ahsanul Karim from the Board of Directors effective as April 3, 2013 and the appointment of Faheemul Huq as a Non-Executive Director. Beximco manufactures a variety of dosage forms including metered dose inhalers, dry powder inhalers, inhalation solutions for nebulization, and nasal … [Read more...] about Beximco announces board changes
Asthmapolis raises $5 million
According to Asthmapolis, the company has raised $5 million in Series A financing from The Social+Capital Partnership (“Social Capital”) that it will use to "deliver new innovations and services for its comprehensive solution of sensors, leading mobile technology and personalized support, extending its reach to the more than 50 million people living with chronic … [Read more...] about Asthmapolis raises $5 million
Insmed gets orphan drug designation for Arikace, appoints new chief commercial officer
According to Insmed Incorporated, the US FDA has granted orphan drug designation to its Arikace liposomal amikacin for inhalation for the treatment of non-tuberculous mycobacteria (NTM) infections. Insmed is also developing Arikace for the treatment of P. aeruginosa infections in cystic fibrosis patients. The company also has announced the appointment of Matthew Pauls … [Read more...] about Insmed gets orphan drug designation for Arikace, appoints new chief commercial officer