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Glenmark gets Russian approval for Momate Rhino nasal spray

According to Glenmark Pharmaceuticals, the Russian Ministry of Healthcare has approved the company's Momate Rhino mometasone furoate nasal spray for over-the-counter sales for the treatment of allergic rhinitis in adults. Glenmark Pharmaceuticals Senior VP and Head,"Asia, Russia & CIS region, Csaba Kantor commented, "Glenmark has built strong capabilities in … [Read more...] about Glenmark gets Russian approval for Momate Rhino nasal spray

Marinomed Biotech says Phase 3 trial of Budesolv nasal spray met primary endpoint

Marinomed Biotech has announced that a Phase 3 trial of Budesolv budesonide nasal spray has met its primary endpoint. Without providing any specific data, the company said that, "The top line results are now available and show that Budesolv achieves at least the same effect as the product which is currently on the market, with a significantly lower dose." According to … [Read more...] about Marinomed Biotech says Phase 3 trial of Budesolv nasal spray met primary endpoint

Satsuma Pharmaceuticals raises $62 million for development of intranasal DHE

Satsuma Pharmaceuticals said that it has raised $62 million in Series B financing that will be used for Phase 3 development of its STS101 intranasal dry powder dihydroergotamine (DHE) for the treatment of migraines. Satsuma was spun off from SNBL in 2017 specifically to develop STS101 and at the time raised $12 million in Series A financing. Earlier this year, the … [Read more...] about Satsuma Pharmaceuticals raises $62 million for development of intranasal DHE

Boehringer Ingelheim completes expansion of Respimat manufacturing facilities

Boehringer Ingelheim said recently that it has completed a €105 million expansion of its facilities in Dortmund and Ingelheim, Germany to increase manufacturing capacity for its Respimat soft mist inhaler. The company said that the expansion has been completed in time to support its launch of a next generation Respimat in Europe this year. The new Respimat is … [Read more...] about Boehringer Ingelheim completes expansion of Respimat manufacturing facilities

Neurelis adds senior management personnel in anticipation of Valtoco nasal spray launch

Neurelis, which submitted an NDA for its Valtoco diazepam nasal spray in September 2018, has announced the appointments of a number of senior management personnel in anticipation of a launch. The appointments announced took place from late 2017 to 2019. The hires include George Stuart as Chief Financial Officer, Chuck DeWildt as Chief Commercial Officer, Adrian … [Read more...] about Neurelis adds senior management personnel in anticipation of Valtoco nasal spray launch

Phase 1 trials of intranasal MDI for otitis media meet primary endpoints

Novus Therapeutics said that two Phase 1 trials of its OP0201 intranasal MDI, which is in development for otitis media, both met their primary endpoints. In one of the studies, healthy adults received either a single 20 mg dose of OP0201 or placebo and were then exposed to pressure changes in a pressure chamber. In the other, adults with acute otitis media received 20 … [Read more...] about Phase 1 trials of intranasal MDI for otitis media meet primary endpoints

FDA approves Akorn’s ANDA for fluticasone propionate nasal spray

Akorn announced that the FDA has approved an ANDA for fluticasone propionate nasal spray submitted by Hi Tech Pharmacal, which was acquired by Akorn in 2014. The nasal spray is a generic of GSK's Flonase, which was approved for OTC sales in the US in 2014. Akorn President and CEO Douglas Boothe said, “We are excited to add to our fluticasone franchise and look … [Read more...] about FDA approves Akorn’s ANDA for fluticasone propionate nasal spray