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
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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
Verona announces positive interim data from Phase 2 study ensifentrine DPI
Verona Pharma said that it plans to initiate the second phase of a two-part Phase 2 trial of its RPL554 ensifentrine DPI in COPD patients after the first part of the study demonstrated that the DPI produced significant improvement in FEV1. The company announced initiation of the study in December 2018. The Phase 2 study enrolled 37 moderate-to-severe COPD patients … [Read more...] about Verona announces positive interim data from Phase 2 study ensifentrine DPI
Acorda launches Inbrija levodopa DPI in the US
Acorda Therapeutics has announced the US launch of the Inbrija levodopa dry powder inhaler in the US. In December 2018, he FDA approved Inbrija for the treatment of OFF episodes in Parkinson's disease patients taking carbidopa/levodopa. The DPI will be available to patients by prescription through certain specialty pharmacies. Acorda President and CEO Ron Cohen … [Read more...] about Acorda launches Inbrija levodopa DPI in the US
Oyster Point raises $93 million for Phase 3 development of intranasal dry eye therapies
Oyster Point Pharma said that it has raised $93 million in a Series B financing round and will use the proceeds for continued development of its OC-01 and OC-02 nicotine acetylcholine receptor (nAChR) agonist nasal sprays for the treatment of dry eye disease. In October 2018, Oyster Point announced that Phase 2b studies of each of the two nasal sprays had met … [Read more...] about Oyster Point raises $93 million for Phase 3 development of intranasal dry eye therapies