The US Patent and Trademark Office (USPTO) has granted OtiTopic, Inc. two patents covering its Asprihale (OTI-0726) inhaled aspirin formulation, which OtiTopic is developing as a rescue treatment for suspected myocardial infarction (MI), the company announced. According to OtiTopic, the Asprihale DPI is also covered by utility patents from the US, Japan, and … [Read more...] about OtiTopic gets patents for inhaled aspirin for the treatment of myocardial infarction
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Aradigm files for bankruptcy, plans to sell all assets
Inhaled liposomal ciprofloxacin developer Aradigm Corporation announced that it has filed for bankruptcy under Chapter 11 of the US Bankruptcy Code and plans to sell all of its assets. The company said that "Aradigm remains confident in the efficacy, safety and quality of Apulmiq (US)/Linhaliq (EMA). We are committed to continue working toward the approval of … [Read more...] about Aradigm files for bankruptcy, plans to sell all assets
Glenmark inhaled RORγt inhibitor to be developed by US spin-off
Glenmark Pharmaceuticals has announced that it plans to spin off a US-based company for development of innovative drugs, including GRC 39815, a retinoid-related orphan receptor gamma t (RORγt) inhibitor in pre-clinical development as a potential inhaled treatment for COPD. The new US-based company is expected to employ over 400 people, and all employees, assets, … [Read more...] about Glenmark inhaled RORγt inhibitor to be developed by US spin-off
VistaGen gets notice of allowance for patent covering PH10 nasal spray for the treatment of depression
The US Patent and Trademark Office (USPTO) has provided VistaGen a notice of allowance regarding a patent covering the use of its PH10 nasal spray for the treatment of depression, the company said. VistaGen announced that it had licensed PH10, a neurosteroid nasal spray, from Pherin Pharmaceuticals in October 2018. PH10 is currently in Phase 2 development for the … [Read more...] about VistaGen gets notice of allowance for patent covering PH10 nasal spray for the treatment of depression
FDA advisory committee recommends approval of Janssen’s intranasal esketamine
The FDA's Psychopharmacologic Drugs Advisory Committee (PDAC) and Drug Safety and Risk Management (DSaRM) Advisory Committee met on February 12, 2019 to consider Janssen's NDA for its esketamine nasal spray for the treatment of treatment-resistant depression in adults and voted in favor of approval. On the question, "Has the Applicant provided substantial evidence … [Read more...] about FDA advisory committee recommends approval of Janssen’s intranasal esketamine
GSK, Mylan launch generic versions of Advair Diskus in US
Both GSK and Mylan have announced the availability of generic versions of GSK's Advair Diskus fluticasone propionate/salmeterol DPI in the US. GSK made a statement regarding its authorized generic on February 8, 2019, and Mylan has responded by announcing the US launch of the Wixela Inhub fluticasone propionate/salmeterol DPI, which was recently approved by … [Read more...] about GSK, Mylan launch generic versions of Advair Diskus in US
Phase 2 trial of FluGen intranasal flu vaccine demonstrates protection against highly mismatched virus
FluGen has announced that preliminary data from a Phase 2 trial show that its intranasal M2SR manufactured with a strain of influenza that was used in vaccines during the 2008-2010 influenza seasons protected against a live H3N2 influenza virus from the 2014-15 flu season. Demonstrating protection against the highly mismatched virus is a "major step toward … [Read more...] about Phase 2 trial of FluGen intranasal flu vaccine demonstrates protection against highly mismatched virus
Pulmatrix gets five new patents for DPI formulations
Pulmatrix announced that it has received five new patents covering PUR1800 and PUR5700, which are inhaled narrow spectrum kinase inhibitors that Pulmatrix licensed from Janssen subsidiary RespiVert in June 2017. The new patents include two US patents (Nos. 9,884,845 B2 and 10,045,980 B2) and two European patents (Nos. 3105222 B1 and 3105223 B1) covering RV-7031, … [Read more...] about Pulmatrix gets five new patents for DPI formulations
Orion’s Easyhaler products to connect to Propeller Health inhaler montitoring platform
Orion and Propeller Health have announced that they will co-develop a custom sensor for Orion's Easyhaler devices that will allow the inhalers to connect to Propeller's digital inhaler monitoring platform. According to the companies, "Development of the sensor will begin in 2019, with clinical trials, possible real world evidence projects and a broader commercial … [Read more...] about Orion’s Easyhaler products to connect to Propeller Health inhaler montitoring platform
FDA clears IND for Phase 2 study of Pulmazole itraconazole DPI
The FDA has cleared Pulmatrix's investigational new drug application, giving the company the go-ahead to begin a Phase 2 clinical trial of Pulmazole (PUR1900) inhaled dry powder itraconazole for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in asthma patients. In November 2018, Pulmatrix said that it planned to initiate a Phase 2 trial by the end … [Read more...] about FDA clears IND for Phase 2 study of Pulmazole itraconazole DPI