The FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) will meet on May 8, 2019 to consider Chiesi's NDA for Bronchitol mannitol DPI for the treatment of cystic fibrosis. According to Bronchitol developer Pharmaxis, its partner Chiesi resubmitted the NDA in December 2018. Bronchitol was approved for the treatment of CF in Europe in 2012, but the FDA issued a … [Read more...] about FDA advisory committee sets date for meeting to reconsider NDA for Bronchitol DPI
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Janssen partners with Monash University on development of inhaled oxytocin
Johnson & Johnson subsidiary Janssen Pharmaceutica has announced that it signed a sponsored research agreement with Monash University's Monash Institute of Pharmaceutical Sciences (MIPS) for development of an inhaled dry powder oxytocin for the prevention and treatment of postpartum hemorrhage. No financial details were included in the announcement. According … [Read more...] about Janssen partners with Monash University on development of inhaled oxytocin
Ultibro Breezhaler and Seebri Breezhaler launched in China
According to Sosei, Novartis has launched the Ultibro Breezhaler indacaterol/glycopyrronium DPI and the Seebri Breezhaler glycopyrronium DPI in China for the treatment of COPD. Huizheng Technology acquired the Chinese licenses for the inhalers from Novartis and has filed applications to add both DPIs to the national health insurance drug list, Sosei … [Read more...] about Ultibro Breezhaler and Seebri Breezhaler launched in China
CBC Corporation partners with Iconovo on generic Symbicort
Iconovo has announced that development of a generic budesonide/formoterol DPI based on its IcoRes inhaler has been transferred to CBC Corporation. Amneal signed a development and licensing deal for the generic version of Symbicort in 2016; CBC will now assume all of Amneal's obligations under that deal. The original agreement with Amneal was described as having … [Read more...] about CBC Corporation partners with Iconovo on generic Symbicort
Altimmune announces new funding, positive results for NasoVax flu vaccine
Altimmune announced that it has raised $14 million in a registered direct offering, with net proceeds of about $12.7 million. The company also said that an extension of a Phase 2 study of its NasoVax intranasal flu vaccine found that subjects were still protected against the flu more than a year after vaccination. The company said that 8 subjects from the original … [Read more...] about Altimmune announces new funding, positive results for NasoVax flu vaccine
Iconovo appoints Roger Lassing as VP Business Development
Swedish DPI company Iconovo has announced the appointment of Roger Lassing as Vice President Business Development. Lassing, who was most recently Senior Manager of Global Business Development at LEO Pharma, has previously held executive positions at Takeda, Nycomed, and AstraZeneca, where he was Global Brand Manager for Symbicort. Over the past few years, Iconovo … [Read more...] about Iconovo appoints Roger Lassing as VP Business Development
Phase 3 trial of Liquidia’s inhaled treprostinil meets primary endpoint
Liquidia Technologies has announced that the Phase 3 INSPIRE study of its LIQ861 DPI in pulmonary arterial hypertension (“PAH”) patients met its primary endpoint. In January 2019, the company announced encouraging preliminary results from the study. According to Liquidia, the 2-month study, which enrolled 109 patients, demonstrated that doses of up to 150 mcg of … [Read more...] about Phase 3 trial of Liquidia’s inhaled treprostinil meets primary endpoint
FDA approves Spravato esketamine nasal spray for the treatment of depression
The FDA announced that it has approved Janssen's NDA for Spravato esketamine nasal spray for the treatment of treatment-resistant depression. Spravato is to be used with an oral antidepressant and distribution will restricted under a risk evaluation and mitigation strategy (REMS). The FDA's Psychopharmacologic Drugs Advisory Committee (PDAC) and Drug Safety and … [Read more...] about FDA approves Spravato esketamine nasal spray for the treatment of depression
Endo files suit against Perrigo alleging infringement of Nascobal patents
Perrigo has announced that Endo Pharmaceuticals filed a patent suit on March 1, 2019 in the United States District Court for the District of Delaware in response to a Perrigo ANDA for a generic version of Nascobal cyanocobalamin nasal spray. Nascobal was originally approved by the FDA in 2015. The Orange Book lists 6 patents for Nascobal nasal spray, all with … [Read more...] about Endo files suit against Perrigo alleging infringement of Nascobal patents
FDA expresses concerns about Evoke’s NDA for Gimoti
Evoke Pharma said that it has received a multi-disciplinary review letter from the FDA regarding its NDA for Gimoti metoclopramide nasal spray for the treatment of diabetic gastroparesis in adult women. According to Evoke, the letter expressed concerns with quality control and reproducibility related to the delivery device, insufficient data supporting differences in … [Read more...] about FDA expresses concerns about Evoke’s NDA for Gimoti