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
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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
Theravance Biopharma opens corporate office in Dublin, Ireland
Theravance Biopharma has opened a corporate office in Dublin, Ireland and plans to hire 30 new employees over the next 2 years, the company said. The company also announced that it and its partner Mylan had presented additional data from 2 Phase 3 trials of TD-4208 inhaled revefenacin at the 2017 CHEST meeting. Topline results from the Phase 3 trials were released … [Read more...] about Theravance Biopharma opens corporate office in Dublin, Ireland
Cyrano Therapeutics partners with Shanghai Newsummit on intranasal theophylline for hyposmia
Cyrano Therapeutics has announced a partnership agreement with Chinese CRO Shanghai Newsummit Biopharma (Newsummit) for development of Cyrano's intranasal theophylline for the treatment of taste and smell disorders in China. Newsummit will provide development services to a new Cyrano subsidiary called Wenzhou Cyrano, with the goal of approval by the … [Read more...] about Cyrano Therapeutics partners with Shanghai Newsummit on intranasal theophylline for hyposmia
Savara to develop Molgradex for the treatment of NTM lung infections
Savara has announced that it will develop its Molgradex inhaled granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of nontuberculous mycobacterial (NTM) lung infection and plans to initiate a Phase 2a trial for that indication in early 2018. The company is also developing Molgradex for the treatment of autoimmune pulmonary alveolar … [Read more...] about Savara to develop Molgradex for the treatment of NTM lung infections
Sunovion launches Seebri Neohaler in the US
Sunovion has announced the US launch of Seebri Neohaler glycopyrrolate DPI for the treatment of COPD. Seebri Neohaler was approved by the FDA in October 2015. Sunovion acquired US rights to Seebri Neohaler, along with the Arcapta indacaterol and Utibron indacaterol/glycopyrrolate Neohalers, from Novartis in December 2016. Seebri Neohaler is known as Seebri … [Read more...] about Sunovion launches Seebri Neohaler in the US
Amneal and Impax announce merger agreement
Amneal Pharmaceuticals and Impax Laboratories have announced that the companies will merge, with the new company to be called Amneal Pharmaceuticals, Inc. The merger is expected to be complete by mid-2018. OINDPs marketed by Amneal include generic versions of TOBI inhalation solution and Astelin and Nasonex nasal sprays. Impax acquired US rights to Zolmig … [Read more...] about Amneal and Impax announce merger agreement
Aegis Therapeutics announces availability of intranasal hydromorphone formulation
Aegis Therapeutics says that it has developed an intranasal hydromorphone for the treatment of acute pain and is making the formulation available for license. According to the company, the formulation, which is based on the Intravail absorption enhancement technology, has demonstrated rapid onset and a Tmax of 7.5 minutes. A patent application filed by Aegis in … [Read more...] about Aegis Therapeutics announces availability of intranasal hydromorphone formulation
Engage Therapeutics closes $23 million series A financing round to fund development of inhaled alprazolam
Engage Therapeutics has closed a $23 million Series A financing round led by TPG Biotech that will fund a Phase 2b clinical trial of an inhaled alprazolam for the treatment of acute epileptic seizures. Alexza Pharmaceuticals, which has developed the Staccato alprazolam through Phase 2a, registered the trademark for Engage Therapeutics in 2015. According to one … [Read more...] about Engage Therapeutics closes $23 million series A financing round to fund development of inhaled alprazolam
Galen acquires US rights to Adasuve inhaled loxapine
Galen US has acquired US rights to Alexza Pharmaceuticals' Adasuve inhaled loxapine for the treatment of agitation in patients with schizophrenia or bipolar I. Adasuve was approved by the FDA in December 2012 for use in certain healthcare facilities enrolled in the Adasuve REMS program only. In May 2013, Teva announced that it had acquired US rights to Adasuve, and … [Read more...] about Galen acquires US rights to Adasuve inhaled loxapine