According to Pulmatrix, a dispute between Pulmatrix and Cipla over funding related to the development of Pulmazole intraconazole DPI (PUR 1900) has been resolved. In May 2021, Pulmatrix announced that Cipla had failed to provide 50% of the development costs for Pulmazole and had therefore breached the terms of their development and commercialization agreement for the … [Read more...] about Pulmatrix and Cipla resolve dispute over Pulmazole funding
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FDA tentatively approves Liquidia’s NDA for Yutrepia treprostinil DPI
According to Liquidia, the FDA has tentatively approved the company's NDA for its Yutrepia (LIQ861) treprostinil DPI for the treatment of pulmonary arterial hypertension (PAH). The FDA had previously issued a complete response letter to the NDA in November 2020. Liquidia refiled the LIQ861 NDA in May 2021, and in August 2021, the agency completed a pre-approval … [Read more...] about FDA tentatively approves Liquidia’s NDA for Yutrepia treprostinil DPI
Switzerland approves Bronchitol DPI as an add-on to other CF medications
According to EffRx Pharmaceuticals, Swissmedic has approved Bronchitol inhaled dry powder mannitol as an add-on to other medications for the treatment of cystic fibrosis in patients 6 years old and older. EffRx acquired Swiss rights to Bronchitol from Pharmaxis in 2019. The company said that it expects to launch the DPI in Switzerland in the second half of … [Read more...] about Switzerland approves Bronchitol DPI as an add-on to other CF medications
Covis acquires global rights to Eklira and Duaklir
Covis Pharma will pay AstraZeneca $270 million for global rights to the Eklira (Turdorza, Bretaris) aclidinium bromide and Duaklir (Brimica) aclidinium bromide/formoterol DPIs, the companies have announced. Both DPIs are marketed for the treatment of COPD. In addition to the $270 million payment, Covis said that it "will also cover certain ongoing development costs" … [Read more...] about Covis acquires global rights to Eklira and Duaklir
Perrigo launches Marinomed’s Carragelose nasal spray in France and Scandinavia
Marinomed Biotech has announced that it signed a distribution agreement with Perrigo for its Carragelose iota-carrageenan nasal spray, and Perrigo has already launched the product in Finland, Norway, Sweden and France. The OTC nasal spray is being marketed for the prevention of respiratory viruses under the name Physiomer in the Scandinavian countries and as Phytosun … [Read more...] about Perrigo launches Marinomed’s Carragelose nasal spray in France and Scandinavia
CF Foundation, Innoviva make equity investments in Armata Pharmaceuticals
Armata Pharmaceuticals announced that the Cystic Fibrosis Foundation has purchased $3 million worth of the company's common stock and that Innoviva subsidiary Innoviva Strategic Opportunities, which already held a significant number of shares in Armata, has invested a further $4 million. The funds will be used to support further development of the company's lead … [Read more...] about CF Foundation, Innoviva make equity investments in Armata Pharmaceuticals
Health Canada clears Phase 1 trial of TFF’s dry powder niclosamide
According to TFF Pharmaceuticals, Health Canada has issued a no objection letter regarding a Phase 1 clinical trial of TFF's dry powder inhaled niclosamide that will evaluate 0.5, 2, and 6 mg doses in healthy volunteers in the SAD phase and 3 and 6 mg doses twice a day for 5 days in the MAD phase. TFF said that it expects dosing to get underway in November 2021 and … [Read more...] about Health Canada clears Phase 1 trial of TFF’s dry powder niclosamide
Copley Scientific launches new nasal dose uniformity sampling apparatus interface
Inhaler testing equipment company Copley Scientific is introducing a new nasal dose uniformity sampling apparatus (DUSA) interface plate designed to work with the company's Vertus II/Plus shake and fire system for delivered dose uniformity testing of nasal products per Ph. Eur. 1 Chapter 0676 and USP Chapter <601>2. Earlier this year, the company announced the … [Read more...] about Copley Scientific launches new nasal dose uniformity sampling apparatus interface
Meissa says preliminary data from Phase 1 trial of its intranasal COVID-19 vaccine look promising
Meissa Vaccines has announced that interim data from a Phase 1 study of its MV-014-212 intranasal recombinant live attenuated COVID-19 vaccine demonstrate that a single dose produced a good nasal IgA response with no reported safety issues. In July 2020, the company said that the Phase 1 trial had begun dosing subjects. According to the new announcement, the interim … [Read more...] about Meissa says preliminary data from Phase 1 trial of its intranasal COVID-19 vaccine look promising
Nemera launches UniSpray device for nasal delivery of systemic drugs
Device company Nemera has announced the launch of a new single metered dose nasal pump called UniSpray, which is designed for delivery of systemic drugs. According to the company, UniSpray requires no priming, is compatible with standard containers, and can be used at any angle. According to the announcement, UniSpray is a "concept under development," and the … [Read more...] about Nemera launches UniSpray device for nasal delivery of systemic drugs