News
-
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… Read more . . .
-
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… Read more . . .
-
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… Read more . . .
-
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… Read more . . .
-
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… Read more . . .
-
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… Read more . . .
-
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.… Read more . . .
-
Innovus Pharmaceuticals says that it has launched FlutiCare fluticasone propionate nasal spray over the counter in the US in independent pharmacies and through its own online sites, as well as through Amazon and Walmart online… Read more . . .
-
Theravance Biopharma and Mylan have submitted an NDA to the FDA for revefenacin inhalation solution (TD-4208) for the treatment of COPD, the companies said. Theravance and Mylan announced their partnership on the development of nebulized… Read more . . .
-
Copley Scientific has announced the availability of 2 new breath simulators, the BRS 2100 and BRS 3100, that can generate patient-derived breathing profiles for inhaler and nebulizer testing in addition to the pharmacopeoeial standard breathing… Read more . . .

Upcoming Events
Sponsored by Intertek
Want information about upcoming OINDP-related events delivered directly to your inbox? click here
May 10-May 14: RDD 2026, Phoenix, AZ, USA
May 15-May 16: ATS Respiratory Innovation Summit 2026, Orlando, FL, USA
May 17-May 20: ATS International Conference 2026, Orlando, FL, USA
June 9-June 10: Nasal Drug Delivery Symposium: Current Status and Future Opportunities, Stockholm, Sweden
June 10: SMI.London 2026, London, UK

