Austrian biotech APEPTICO said that it has signed a grant agreement with the European Commission to accelerate the availability of the company's solnatide (AP301), an inhaled peptide, available for treatment of patients with severe COVID-19. APEPTICO had been invited to apply for a grant through the Horizon 2020 “Advancing knowledge for the clinical and public health … [Read more...] about APEPTICO signs grant agreement with EC to accelerate availability of inhaled solnatide for COVID-19
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Lee’s provides funding for Phase 2b study of Windtree’s Aerosurf for RDS in premature infants
Windtree Therapeutics has announced that Lee's Pharmaceutical Holdings will provide funding for a Phase 2b study of Windtree's Aerosurf inhaled KL4 surfactant for the treatment of respiratory distress syndrome in preterm infants. Windtree will repay 125% of the funding to Lee's from revenues or other payments resulting from activities related to the KL4 … [Read more...] about Lee’s provides funding for Phase 2b study of Windtree’s Aerosurf for RDS in premature infants
Nephron Pharmaceuticals looking to increase inhalation solution and suspension production capacity
Nephron Pharmaceuticals CEO Lou Kennedy spoke to local reporters in the company's home state of South Carolina on March 17, 2020, describing the company's efforts to increase production of its inhalation solutions and suspensions to meet demand during the COVID-19 pandemic. Nephron produces its own inhalation products; including albuterol, ipratroprium bromide, … [Read more...] about Nephron Pharmaceuticals looking to increase inhalation solution and suspension production capacity
Pharmascience launches its generic fluticasone propionate/salmeterol DPI in Canada
Montreal-based Pharmascience has announced the launch of its pms-fluticasone propionate/salmeterol DPI in Canada for the treatment of asthma and COPD. The company says that the DPI uses the same device as Advair Diskus. According to the Health Canada Drug Product Database, three strengths of pms-fluticasone propionate/salmeterol DPI (100mcg/50mcg, 250mcg/50mcg, and … [Read more...] about Pharmascience launches its generic fluticasone propionate/salmeterol DPI in Canada
MannKind to focus R&D on potential COVID-19 therapies, collaboration with Immix
Inhaled drug developer MannKind Corporation has announced that it "is committed to joining the global effort to overcome the COVID-19 crisis" and as a result "that it is adjusting research and development resources that were reserved for its pipeline of investigational products for treating serious lung diseases, with the goal of prioritizing work on new compounds … [Read more...] about MannKind to focus R&D on potential COVID-19 therapies, collaboration with Immix
Insmed submits NDA for Arikayce in Japan, announces COVID-19 measures
Insmed has announced its submission of a new drug application to Japan's Ministry of Health, Labour and Welfare (MHLW) for Arikayce amikacin liposome inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) who have not responded to other therapies sufficiently. Arikayce was approved by the … [Read more...] about Insmed submits NDA for Arikayce in Japan, announces COVID-19 measures
FDA lists Arcapta, Seebri, and Utibron Neohalers as discontinued (updated)
According to the FDA, three DPIs marketed by Sunovion in the US have been discontinued as of March 10, 2020. Sunovion acquired the US rights to Utibron (indacaterol/glycopyrrolate) Neohaler, Seebri (glycopyrrolate) Neohaler, and Arcapta (indacaterol) Neohaler from Novartis in December 2016. The inhalers are marketed elsewhere as Ultibro Breezhaler, Seebri Breezhaler, … [Read more...] about FDA lists Arcapta, Seebri, and Utibron Neohalers as discontinued (updated)
Senzer obtains IND data package for inhaled dronabinol from Insys Therapeutics
According to Senzer, the company has obtained the IND application and data package for its inhaled dronabinol from its former partner, Insys Therapeutics, and will now move ahead with development for the treatment of side effects from chemotherapy and for neuropathic pain. Insys filed for bankruptcy in June 2019. Senzer partnered with Insys in 2015 to develop … [Read more...] about Senzer obtains IND data package for inhaled dronabinol from Insys Therapeutics
Mylan launches Wixela Inhub in Canada
Mylan Pharmaceuticals has announced the launch of the Wixela Inhub fluticasone propionate/salmeterol DPI in Canada. According to the company, Health Canada approved Wixela Inhub, a generic version of Advair Diskus, in January 2020 for asthma and COPD. The inhaler will be available in 100 mcg/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg strengths for asthma and 250 … [Read more...] about Mylan launches Wixela Inhub in Canada
Neurelis launches Valtoco nasal spray in the US
Neurelis has announced the launch of Valtoco diazepam nasal spray for the treatment of seizure clusters in the US. The FDA approved Valtoco for the treatment of acute repetitive seizures in epilepsy patients aged 6 and older in January 2020. According to the company, patients can now obtain Valtoco through Maxor Specialty Pharmacy, which has already started filling … [Read more...] about Neurelis launches Valtoco nasal spray in the US