Medical

Liquidia Technologies has presented preclinical and Phase 1 study results for its LIQ861 inhaled treprostinil for the treatment of pulmonary arterial hypertension at the Annual World Congress of the Pulmonary Vascular Research Institute (PVRI), noting that the data supported advancement of LIQ861 into the INSPIRE Phase 3 trial which was initiated earlier this month. … [Read more...] about Liquidia announces positive results from Phase 1 trial of LIQ861 trepostinil DPI

The UK Medicines and Healthcare Products Regulatory Agency has approved a Clinical Trial Application filed by Pulmatrix for a Phase 1/1b study of Pulmazole (PUR1900) inhaled dry powder itraconazole for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in asthma patients, the company said. In October 2017, Pulmatrix announced that PUR1900 received … [Read more...] about Pulmatrix announces Phase 1/1b study of Pulmazole inhaled intraconazole

Eurocine Vaccines has received authorization from the Swedish Medical Products Agency for a Phase 1/2 clinical study of its intranasal quadrivalent influenza vaccine Immunose Flu during the current flu season, the company said. Eurocine Vaccines also ran a Phase 1/2 study of Immunose Flu in 2016. Immunose Flu is based on the company's Endocine nasal vaccine … [Read more...] about Eurocine Vaccines announces Phase 1/2 study of Immunose Flu vaccine

Functional respiratory imaging specialist FLUIDDA has announced a new research collaboration with a team at the University of California, San Francisco led by Professor John Fahy that will use FLUIDDA technology "to understand the effects of pathologic mucus on lung function and on the deposition patterns of inhaled therapeutics." FLUIDDA CEO Jan De Backer said, … [Read more...] about FLUIDDA announces research collaboration with UCSF

A Phase 3 trial of Liquidia Technologies' LIQ861 treprostinil DPI for the treatment of pulmonary arterial hypertension (PAH) is underway, the company said. The study is expected to enroll a minimum of 100 PAH patients in the US, with topline data anticipated in 2019. LIQ861, a dry powder formulation based on Liquidia’s PRINT particle engineering technology, is one … [Read more...] about Liquidia announces initiation of Phase 3 trial of trepostinil DPI for PAH

Janssen Research & Development has published data from a Phase 2 study of its intranasal esketamine that demonstrate rapid improvement of symptoms in patients with treatment-resistant depression. The study was conducted from 2014-2015, and results were published in JAMA Psychiatry on December 27, 2017. The trial enrolled 126 patients diagnosed with major … [Read more...] about Janssen publishes results from Phase 2 trial of intranasal esketamine for depression

Glenmark Pharmaceuticals has announced that a 52-week Phase 3 trial of its Ryaltris mometasone furoate/olopatadine hydrochloride nasal spray for the treatment of perennial allergic rhinitis (PAR) met its primary and secondary endpoints. The company said that it plans to submit an NDA for Ryaltris for seasonal allergic rhinitis (SAR) early in 2018. Earlier this … [Read more...] about Phase 3 trial of Glenmark’s Ryaltris nasal spray meets its primary endpoint

Insys Therapeutics has announced the initiation of a Phase 1 proof-of-concept study to determine whether an epinephrine nasal spray for the treatment of anaphylaxis is bioequivalent to intramuscular injection of epinephrine. The trial will compare both aqueous and hydro-alcoholic formulations of intranasal epinephrine to EpiPen. The study, which is expected to … [Read more...] about Insys initiates Phase 1 study of intranasal epinephrine

Mucodel Pharma has announced that a PK study of its intranasal naloxone met its endpoints and showed that the formulation based on its Co-Gel technology delivered the dose of naloxone faster than both an intranasal spray and intramuscular injection. in February 2017, the Mucodel filed a citizen petition with the FDA challenging the the safety of intranasal … [Read more...] about Mucodel announces positive results for study of intranasal naloxone