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CHMP recommends approval of Arikayce inhaled liposomal amikacin for NTM lung infections

According to Insmed, the EMA's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion regarding approval of the company's Arikayce nebulized liposomal amikacin for the treatment of non-tuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC) in patients who do not have cystic fibrosis. According to … [Read more...] about CHMP recommends approval of Arikayce inhaled liposomal amikacin for NTM lung infections

Milestone Pharmaceuticals raises $25 million, provides update on etripamil development

Milestone Pharmaceuticals said that it has raised $25 million from RTW Investments in a private placement and indicated that the proceeds would be sufficient for company operations through the second quarter of 2022. The company also announced that it had reached an agreement with the FDA regarding modifications to the design of a pivotal trial of its etripamil nasal … [Read more...] about Milestone Pharmaceuticals raises $25 million, provides update on etripamil development

United Therapeutics gets new patent for Tyvaso, adds to patent infringement claims against Liquidia

United Therapeutics announced that it has been issued a new US patent covering Tyvaso treprostinil inhalation solution for the treatment of pulmonary arterial hypertension and that it has subsequently amended its recently filed suit against Liquidia Technologies to include infringement of the new patent. The patent infringement suit initially referenced two US … [Read more...] about United Therapeutics gets new patent for Tyvaso, adds to patent infringement claims against Liquidia

VistaGen announces details of proposed Phase 3 trial of PH94B nasal spray for anxiety

 VistaGen Therapeutics said that the FDA has agreed to details of a proposed Phase 3 trial of the company's PH94B aloradine nasal spray for the treatment of social anxiety disorder (SAD). PH94B was granted Fast Track designation for that indication in December 2019. According to VistaGen, the Phase 3 trial will include "a single-event, laboratory-simulated public … [Read more...] about VistaGen announces details of proposed Phase 3 trial of PH94B nasal spray for anxiety

Janssen announces launch of Spravato esketamine nasal spray in Canada

Health Canada has issued a Notice of Compliance for Janssen Pharmaceutical's Spravato esketamine nasal spray for the treatment of major depressive disorder, and the product is now available to Canadian patients, the company said. Spravato is meant to be used under direct supervision of a healthcare professional, and in combination with an oral antidepressant, when … [Read more...] about Janssen announces launch of Spravato esketamine nasal spray in Canada

MannKind names Alejandro Galindo as Chief Commercial Officer

MannKind Corporation has announced the appointment of Alejandro Galindo as Chief Commercial Officer. Galindo most recently headed the Intensive Insulin Management business unit at Medtronic and previously served in a number of roles at GE Healthcare. In addition to marketing its Afrezza inhaled insulin, which was approved by the FDA in 2014, MannKind is partnered … [Read more...] about MannKind names Alejandro Galindo as Chief Commercial Officer

Synairgen’s inhaled interferon-beta-1a demonstrates significant benefit in hospitalized COVID-19 patients

Synairgen has announced that a Phase 2 clinical trial of its SNG001 nebulized interferon-beta-1a demonstrated that hospitalized COVID-19 patients receiving the drug were two times more likely to recover over the course of treatment; had significantly less dyspnea; and had a 79% lower risk of requiring ventilation and/or dying than patients receiving a a placebo. … [Read more...] about Synairgen’s inhaled interferon-beta-1a demonstrates significant benefit in hospitalized COVID-19 patients

Verona Pharma raises approximately $200 million for Phase 3 development of nebulized ensifentrine

Verona Pharma announced that it has raised approximately $200 million in a private placement, with net proceeds of ~$183 million to be used for Phase 3 development of nebulized ensifentrine for the treatment of COPD. The company said that the Phase 3 ENHANCE (Ensifentrine as a Novel inHAled Nebulized COPD thErapy) program is expected to begin later this year. In … [Read more...] about Verona Pharma raises approximately $200 million for Phase 3 development of nebulized ensifentrine

Atossa to advance AT-301 nasal spray into clinical development for COVID-19

Atossa Therapeutics said that preclinical testing of its AT-301 nasal spray in VERO cells has demonstrated that it can limit SARS-CoV-2 infectivity, and the company has contracted with Australian CRO Advance Clinical for a Phase 1 trial, which is expected to begin this quarter. The company also said that it has filed provisional patent applications in the US to cover … [Read more...] about Atossa to advance AT-301 nasal spray into clinical development for COVID-19