Cohero Health and H&T Presspart have announced the availability of a new connected metered dose inhaler (eMDI). The eMDI collects actuation data from an integral sensor and transmits the data via Bluetooth to Cohero Health's tracking platform. According to the companies, the system is compatible with all canisters and valves. H&T Presspart Chairman Peter Schmelzer … [Read more...] about H&T Presspart and Cohero Health announce new eMDI
News
Chiesi reports significant growth in respiratory drug sales, R&D expenditures for 2015
Chiesi has reported a greater than 9% increase in revenue from 2014 to 2015, with an almost 20% increase in sales of Foster (Fostair) beclamethasone/formoterol inhalers and an unspecified increase in sales of Clenil beclamethasone products. The increase was also partly attributed to the "swift and smooth" integration of Cornerstone Therapeutics,which Chiesi acquired … [Read more...] about Chiesi reports significant growth in respiratory drug sales, R&D expenditures for 2015
FDA warns online retailer over unapproved epinephrine DPI
On March 10, 2016, the Philadelphia District Office of the FDA issued a warning letter to online retailer Dr Natural Healing about sales of epinephrine capsules packaged with a dry powder inhaler as a treatment for asthma. The letter gives the company 15 working days to respond. As of March 31, the website is still offering the "Prime Asthma Relief" products for sale, … [Read more...] about FDA warns online retailer over unapproved epinephrine DPI
Mundipharma submits MAA for flutiform K-Haler breath-activated MDI
Mundipharma has submitted a marketing application to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the flutiform fluticasone/formoterol K-Haler breath-activated MDI for the treatment of asthma, the company said. The submission will be reviewed through the decentralized procedure. In 2006, Mundipharma acquired European rights to flutiform … [Read more...] about Mundipharma submits MAA for flutiform K-Haler breath-activated MDI
FDA approves sNDA for Stiolto Respimat
According to Boehringer Ingelheim Pharmaceuticals, the FDA has approved a supplemental NDA for the Stiolto Respimat tiotropium/olodaterol SMI for a labeling change to add quality of life data obtained from the OTEMTO 1&2 studies. Stiolto Respimat, which was initially approved for the treatment of COPD by the FDA in May 2015, is approved as Spiolto Respimat in some … [Read more...] about FDA approves sNDA for Stiolto Respimat
Kamada submits MAA for inhaled AAT
Kamada has submitted a Marketing Authorization Application for its inhaled alpha-1 antitrypsin (AAT) therapy for the treatment of AAT deficiency to the European Medicines Agency, and the filing EMA has validated the application, the company said. In September 2014, Kamada announced that it planned to move forward with regulatory submissions for inhaled AAT despite … [Read more...] about Kamada submits MAA for inhaled AAT
BI and Propeller Health announce new partnership
Boehringer Ingelheim and Propeller Health have announced a new partnership that will allow COPD and asthma patients using Respimat inhalers "to enroll at select US health systems in a new program that is designed to determine how Propeller’s novel health technology tool for the Respimat inhaler impacts adherence rates and patient engagement." Propeller received 510(k) … [Read more...] about BI and Propeller Health announce new partnership
Raptor’s inhaled levofloxacin gets QIDP status
The FDA has granted Qualified Infectious Disease Product (QIDP) designation to Raptor Pharmaceutical's MP-376 inhaled levofloxacin for the treatment of chronic P. aeruginosa lung infections in patients with cystic fibrosis, non-cystic fibrosis bronchiectasis (BE), and nontuberculous mycobacteria (NTM). Raptor has previously received orphan designation from the FDA for … [Read more...] about Raptor’s inhaled levofloxacin gets QIDP status
Study shows effectiveness of teach-to-goal inhaler education
A study published online ahead of print in the Annals of the American Thoracic Society (AnnalsATS) finds that a "teach-to-goal" inhaler education strategy reduced rescue inhaler misuse to 11% compared to 60% for a "brief instruction" approach immediately after education. Clinical outcomes were significant better for the teach-to-goal group, especially among patients … [Read more...] about Study shows effectiveness of teach-to-goal inhaler education
Apotex launches generic version of Nasonex in the US
Apotex has launched a generic version of Merck's Nasonex mometasone furoate nasal spray in the United States, the company said. In June 2012, A US District Court judge upheld a Merck patent on mometasone furoate (US Patent No. 6,127,353) but ruled that Apotex's nasal spray did not infringe on that patent. According to the FDA, the agency approved Apotex's ANDA for … [Read more...] about Apotex launches generic version of Nasonex in the US