Savara has received a development award of up to $5 million from Cystic Fibrosis Foundation Therapeutics (CFFT), which will support the Phase 3 AVAIL study of the AeroVanc DPI for the treatment of MRSA lung infections in cystic fibrosis patients, the company said. In 2013, CFFT awarded the company $1.7 million for Phase 2 development of AeroVanc. Savara announced … [Read more...] about Savara gets $5 million from CFFT for AeroVanc development
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Study shows improved lung function for patients switching from Seretide (Advair) to Ultibro (Utibron)
Novartis has announced that the FLASH study met its primary endpoint, demonstrating that switching COPD patients from Seretide (Advair) salmeterol/fluticasone Ultibro Breezhaler (Utibron Neohaler) indacaterol/glycopyrronium significantly improved lung function. The safety and tolerability of both inhalers was found to be similar. In 2014, Novartis announced results … [Read more...] about Study shows improved lung function for patients switching from Seretide (Advair) to Ultibro (Utibron)
Phase 3 study of inhaled amikacin in intubated and mechanically ventilated patients fails to meet primary endpoint
Bayer has announced the failure of the Phase 3 INHALE study of Amikacin Inhale inhalation solution for the treatment of gram-negative pneumonia in intubated and mechanically ventilated patients with Gram-negative pneumonia to demonstrate superiority in an inhaled placebo and therefore the failure of the study to meet either its primary or secondary endpoints. … [Read more...] about Phase 3 study of inhaled amikacin in intubated and mechanically ventilated patients fails to meet primary endpoint
GSK files sNDA for Trelegy
GlaxoSmithKline and Innoviva have announced the submission of a supplemental New Drug Application for broader use of Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol DPI for COPD based on data from the IMPACT study. Trelegy Ellipta was initially approved by the FDA in September 2017 for COPD patients already using the Breo Ellipta fluticasone … [Read more...] about GSK files sNDA for Trelegy
Chiesi and Kamada end agreement for European distribution of inhaled AAT
Kamada has announced that an agreement with Chiesi for European distribution of Kamada's inhaled Alpha-1 Antitrypsin (AAT) has been terminated. According to Kamada, the companies mutually agreed to end the agreement because Kamada recently withdrew its MAA for inhaled AAT, and "a European distribution agreement within the pact’s defined timeframe is not currently … [Read more...] about Chiesi and Kamada end agreement for European distribution of inhaled AAT
Cipla gets FDA approval for generic version of Pulmicort Respules
According to Cipla, the company's ANDA for generic budesonide inhalation suspension has been approved by the FDA for the treatment of asthma in children aged 12 months to 8 years. Cipla will market the generic version of Pulmicort Respules in 0.25mg/2mL, 0.5mg/2mL, and 1mg/2mL strengths, with product available for shipping immediately. Read the Cipla press … [Read more...] about Cipla gets FDA approval for generic version of Pulmicort Respules
FDA advisory committee recommends against approval of Bayer’s ciprofloxacin DPI
The FDA's Antimicrobial Drugs Advisory Committee (AMDAC) met on November 16, 2017 to consider Bayer HealthCare's NDA for ciprofloxacin inhalation powder for the reduction of exacerbations in non-cystic fibrosis bronchiectasis patients who have bacterial lung infections. After discussion, the members of the committee voted against recommendation of approval for both of … [Read more...] about FDA advisory committee recommends against approval of Bayer’s ciprofloxacin DPI
Propeller Health partners with Express Scripts to provide inhaler monitoring
Propeller Health has partnered with US pharmacy benefits manager Express Scripts to provide Propeller's inhaler monitoring platform to asthma and COPD patients enrolled in Express Scripts' Pulmonary Care Value Program. According to the companies, patients enrolled in a pilot program run by Express Scripts significantly improved adherence and used rescue inhalers 80% … [Read more...] about Propeller Health partners with Express Scripts to provide inhaler monitoring
Trelegy Ellipta approved in Europe
The European Commission has approved GSK's marketing authorization application for Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol DPI for the treatment of COPD, the company said. The EMA Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion regarding the Trelegy Ellipta MAA in September 2017. According to GSK, the … [Read more...] about Trelegy Ellipta approved in Europe
Pharmaterials acquired by Quotient Sciences
CDMO Pharmaterials, which offers a wide range of development and manufacturing services for inhaled drugs, has been acquired by Quotient Sciences, Quotient said. Pharmaterials was previously owned by PII, which acquired the company in 2008. In 2014, Pharmaterials announced that it was adding a dedicated inhalation development laboratory as part of an expansion of … [Read more...] about Pharmaterials acquired by Quotient Sciences