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 stores. The company said that it plans to introduce the product in large retail stores in the next phase of the launch. Earlier this year, … [Read more...] about Innovus launches FlutiCare OTC nasal spray in US
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Mylan and Theravance submit NDA for revefenacin inhlation solution
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 TD-4208 in early 2015. In October 2016, the companies reported positive results from 2 Phase 3 efficacy studies, with positive … [Read more...] about Mylan and Theravance submit NDA for revefenacin inhlation solution
Copley Scientific launches new breath simulators capable of generating patient-derived breathing profiles
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 profiles. Compared to previous generations, the new breath simulators are faster an more flexible, the company said. The … [Read more...] about Copley Scientific launches new breath simulators capable of generating patient-derived breathing profiles
Evoke Pharma selects Patheon for manufacture of Gimoti intranasal metoclopramide
Evoke Pharma has announced that has signed a 5-year agreement with CDMO Patheon for commercial manufacturing of Evoke's Gimoti intranasal metoclopramide for the treatment of diabetic gastroparesis. Patheon was acquired by Thermo Fisher earlier this year. In October 2017, Evoke announced that it plans to submit a 505(b)(2) NDA for Gimoti early in 2018 based on … [Read more...] about Evoke Pharma selects Patheon for manufacture of Gimoti intranasal metoclopramide
Neurelis gets Japanese patent for intranasal diazepam formulation
The Japan Patent Office has allowed JP Application No. 2014-515967 which covers Neurelis' NRL-1 intranasal diazepam formulation, the company said. In January 2017, Neurelis received Fast Track designation from the US FDA for NRL-1, which had previously received Orphan Drug designation in 2015. The company announced the initiation of pivotal trials for NRL-1 for … [Read more...] about Neurelis gets Japanese patent for intranasal diazepam formulation
Novoclem gets QIDP designation for its inhaled antimicrobial BIOC51
Novoclem Therapeutics says that its BIOC51 inhaled antimicrobial has received Qualified Infectious Disease Product (QIDP) designation from the FDA. The company says that BIOC51 could be delivered as either a dry powder or as an inhalation solution for the treatment of P. aeruginosa lung infections in cystic fibrosis patients. According to Novoclem, "BIOC51 is a … [Read more...] about Novoclem gets QIDP designation for its inhaled antimicrobial BIOC51
H&T Presspart opens manufacturing line for dose counter/indicator
In a series of tweets, H&T Presspart has announced the official opening of a new dose counter/dose indicator manufacturing line at its facility in Marsberg, Germany. In 2014, 3M Drug Delivery Systems announced that it had reached a licensing agreement with Presspart for sales of its Dose by Dose counter and dose indicator. According to H&T Presspart, the … [Read more...] about H&T Presspart opens manufacturing line for dose counter/indicator
Pneuma Respiratory introduces digital soft mist inhaler
US-based Pneuma Respiratory says that it has developed a digital,soft mist inhaler with an electronic droplet ejector system capable of delivering different droplet sizes. According to the company, the device has been validated by two clinical studies in COPD patients. The SMI is breath actuated and connects to a mobile app to track delivery data. Guangxi Li of the … [Read more...] about Pneuma Respiratory introduces digital soft mist inhaler
Therapix Biosciences appoints Ascher Shmulewitz as interim CEO
Intranasal cannabinoid developer Therapix Biosciences has announced the appointment of its Chairman of the Board Ascher Shmulewitz as interim CEO. In May 2017, the company said that it was looking for a US-based CEO after Elran Haber stepped down from the role. Therapix licensed an intranasal cannabinoid formulation from Hebrew University’s technology transfer … [Read more...] about Therapix Biosciences appoints Ascher Shmulewitz as interim CEO
Bayer launches line of pediatric saline nasal sprays in US
Bayer has launched a line of saline nasal sprays for children aged 6 months and older in the US, the company said. The products, which include hydraSense Ultra-Gentle Nasal Mist, hydraSense Nasal Care Single-Use Vials and hydraSense Soft Comfort Tip Nasal Aspirator, are available exclusively at Walgreens drug stores. The company is promoting the products as "made … [Read more...] about Bayer launches line of pediatric saline nasal sprays in US