According to AstraZeneca, the EMA's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the company’s Trixeo Aerosphere formoterol fumarate/ glycopyrronium bromide / budesonide MDI for the treatment of patients with moderate to severe COPD that is not treated adequately an ICS/LABA or LABA/LAMA combination. Trixeo Aerosphere is known … [Read more...] about CHMP recommends approval of Trixeo (Breztri) Aerosphere
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Arcinova adds 3P Innovation micro-dosing system
CDMO Arcinova has added a 3P Innovation R1000 micro-dosing system at its facility in Alnwick, UK in what it called its "Fill-Inova" project, the company said. The R1000 machine includes two of 3P's Fill2Weight filling modules, which can be used to fill API-only or lactose blend formulations into inhalers, capsules, and blisters. According to Arcinova, the new machine … [Read more...] about Arcinova adds 3P Innovation micro-dosing system
Synspira gets additional CF Foundation funding for development of inhaled glycopolymer
The Cystic Fibrosis Foundation (CFF) has awarded Synspira Therapeutics up to $14 million in additional funding for development of two Synspira candidates including SNSP113, an inhaled polycationic glycopolymer for the treatment of CF. The foundation had previously awarded Synspira $8.55 million in 2017. SNSP113, which is currently in Phase 2 development, received … [Read more...] about Synspira gets additional CF Foundation funding for development of inhaled glycopolymer
Positive Phase 1 and Phase 2a results for clinical trials of Respira’s vardenafil DPI
Respira Therapeutics has announced that the results of Phase 1 and Phase 2a clinical studies of RT234-PAH dry powder vardenafil "support its further development as an as-needed (PRN) treatment that will allow patient-controlled dosing to acutely improve episodic symptoms and exercise capacity in pulmonary arterial hypertension (PAH) patients." The company is … [Read more...] about Positive Phase 1 and Phase 2a results for clinical trials of Respira’s vardenafil DPI
Avalyn announces results of Phase 1/2 study of inhaled pirfenidone in IPF patients
Avalyn Pharma said that idiopathic pulmonary fibrosis (IPF) patients who received the higher dose tested in a Phase 1/2 study of the company's AP01 pirfenidone inhalation solution "had a trend toward stabilization of lung function," while those on the lower dose continued a decline in lung function over 24 weeks. As a result, all of the patients who are continuing in … [Read more...] about Avalyn announces results of Phase 1/2 study of inhaled pirfenidone in IPF patients
Armata Pharmaceuticals announces plans for Phase 1b/2a trial of inhaled phage in CF patients
Armata Pharmaceuticals announced that it plans to initiate clinical development of inhaled AP-PA02, a phage cocktail the company is developing for the treatment of P. aeruginosa infections in cystic fibrosis patients. The SAD portion of the Phase 1b/2a SWARM-P.a. study is expected to begin by the end of 2020. Armata Pharmaceuticals CEO Todd R. … [Read more...] about Armata Pharmaceuticals announces plans for Phase 1b/2a trial of inhaled phage in CF patients
US PTAB institutes inter partes review of Tyvaso patent
Liquidia Technologies said that the US Patent Trial and Appeal Board (PTAB) has issued decisions on two patents related to Tyvaso treprostinil inhalation solution, which is marketed by United Therapeutics for the treatment of pulmonary arterial hypertension (PAH). Liquidia filed petitions with the US Patent and Trademark Office seeking to invalidate the two patents in … [Read more...] about US PTAB institutes inter partes review of Tyvaso patent
CPhI awards recognize OINDP companies
With CPhI 2020 having been converted into the virtual "Festival of Pharma" due to the COVID-19 pandemic, the CPhI Pharma Awards ceremony took place online via a live streamed event on October 13. Winners in were announced in 13 categories, including a new category specifically devoted to COVID-19 responses. A number of OINDP companies were among the finalists, … [Read more...] about CPhI awards recognize OINDP companies
Phase 1 study of Ionis inhaled antisense therapy in CF patients demonstrates significant reduction in ENaC messenger RNA
Ionis Pharmaceuticals has announced data from a Phase 1 SAD/MAD study of its IONIS-ENAC-2.5Rx nebulized antisense therapy in cystic fibrosis patients demonstrating a mean 55.6% reduction of epithelial sodium channel (ENaC) messenger RNA in cystic fibrosis patients who received a 75 mg dose in the MAD portion of the study. According to the company, preclinical studies … [Read more...] about Phase 1 study of Ionis inhaled antisense therapy in CF patients demonstrates significant reduction in ENaC messenger RNA
Nasus Pharma says its Taffix intranasal HPMC significantly reduced SARS-CoV-2 infection in real world superspreader event
Israeli biopharma company Nasus Pharma says that it provided its Taffix intranasal hydroxypropyl methylcellulose (HPMC) powder to members of a synagogue for use during Rosh Hashana celebrations, and worshippers who used Taffix were infected with SARS-CoV-2 at one quarter the rate of those who did not use the nasal powder. The members of the synagogue were in close … [Read more...] about Nasus Pharma says its Taffix intranasal HPMC significantly reduced SARS-CoV-2 infection in real world superspreader event