Glenmark Pharmaceuticals said that it plans to launch Ryaltris olopatadine / mometasone furoate nasal spray for the treatment of allergic rhinitis in 16 European Union countries and the UK after finalizing marketing approval. Menarini Group will commercialize Ryaltris in some of the companies, including France, Italy, Spain, and the Balkans, under a December 2020 … [Read more...] about Ryaltris nasal spray approved in the EU
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AireHealth names Kien Nguyen as CEO
Connected nebulizer maker AireHealth has announced the appointment of Kien Nguyen as its new CEO and as a member of its board. Nguyen was most recently Chief Commercial Officer at Progenerative Medical. In December 2020, AireHealth announced that it had received 510(k) clearance for its VitalMed connected portable vibrating mesh nebulizer. AireHealth Kien … [Read more...] about AireHealth names Kien Nguyen as CEO
Chiesi gets EC approval for Trimbow Nexthaler triple combination DPI for the treatment of COPD
The European Commission has approved Chiesi's Trimbow Nexthaler extrafine beclometasone dipropionate / formoterol fumarate / glycopyrronium DPI for the treatment of moderate to severe COPD in patients not adequately treated with an ICS/LABA or LABA/LAMA combination, the company said. Chiesi's Trimbow triple combination MDI was approved in Europe for the treatment … [Read more...] about Chiesi gets EC approval for Trimbow Nexthaler triple combination DPI for the treatment of COPD
Nob Hill Therapeutics names Paul Atkins as Executive Chairman
Dry powder nebulizer maker Nob Hill Therapeutics has named former Oriel Therapeutics President and CEO Paul Atkins as Executive Chairman. Atkins headed DPI developer Oriel until the company was acquired by Sandoz in 2010 and subsequently served as VP, Operations at Sandoz until 2020. According to the Nob Hill web site, its DryNeb "dry powder nebulizer is a … [Read more...] about Nob Hill Therapeutics names Paul Atkins as Executive Chairman
Hikma re-starts launch of its generic version of Advair Diskus
Hikma Pharmaceuticals said that the FDA has approved an amendment to the company's ANDA for its generic version of Advair Diskus fluticasone propionate / salmeterol DPI, and the company has subsequently restarted the launch of the inhaler. The FDA initially approved the ANDA in December 2020, and the company said that it was launching the DPI at that time. Hikma … [Read more...] about Hikma re-starts launch of its generic version of Advair Diskus
Inhalation Sciences takes steps to expand its business in the US
Swedish aerosol research instrument maker Inhalation Sciences (ISAB) says that the company intends to expand its presence in the US in 2021 and has signed agreements with lead generation company Cience and with CRO consultant Coelus Bio to help it achieve that goal. In October 2020, ISAB announced that it had been granted a US patent for its PreciseInhale laboratory … [Read more...] about Inhalation Sciences takes steps to expand its business in the US
NeuroRx and Relief Therapeutics publicly air disputes over Zyesami collaboration agreement
NeuroRx and Relief Therapeutics have each issued press releases enumerating disagreements between the companies regarding development of Zyesami aviptadil (RLF-100), a synthetic vasoactive intestinal peptide. The two companies are partnered on development of the formulation for the treatment of acute respiratory distress syndrome caused by COVID-19, for both … [Read more...] about NeuroRx and Relief Therapeutics publicly air disputes over Zyesami collaboration agreement
Phase 3 trial of ciclesonide MDI for the treatment of COVID-19 fails to meet primary endpoint
Covis Pharma said that a Phase 3 trial of Alvesco ciclesonide MDI for the treatment of COVID-19 in 400 patients who have not been hospitalized failed to meet its primary endpoint, which was freedom from COVID-19 symptoms for 24 continuous hours by Day 30. The difference in time to alleviation of patients' COVID-19 symptoms was 70.6% for the ciclesonide MDI and 63.5% … [Read more...] about Phase 3 trial of ciclesonide MDI for the treatment of COVID-19 fails to meet primary endpoint
United Therapeutics submits NDA for Tyvaso DPI
United Therapeutics said that it has submitted an NDA for its Tyvaso treprostinil DPI for the treatment of pulmonary arterial hypertension (PAH) and has applied a priority review voucher that it acquired for $105 million in December 2020. With the use of the priority review voucher, the FDA could issue a decision regarding the NDA by the end of 2021. In 2018, … [Read more...] about United Therapeutics submits NDA for Tyvaso DPI
Virpax says MMS019 nasal spray inhibits viral replication in pre-clinical study
Virpax Pharmaceuticals announced that a study of its MMS019 powder "masking spray" in mice demonstrated "a marked inhibition of viral replication in the mouse nasal passages" for mice infected with SARS-CoV-2 and then given MMS019 intranasally for 6 days. Virpax licensed MMS019 from Nanomerics in August 2020 and is developing the formulation for the prevention of … [Read more...] about Virpax says MMS019 nasal spray inhibits viral replication in pre-clinical study