The FDA has approved Janssen Pharmaceutical's sNDA for the expanded use of Spravato esketamine CIII nasal spray for the treatment of major depressive disorder with acute suicidal ideation or behavior, the company said. Spravato was initially approved by the FDA in March 2019 for the treatment of treatment-resistant depression, and Janssen announced the … [Read more...] about FDA approves Spravato esketamine nasal spray for depression with suicidal ideation
Regulatory
FDA approves Breztri Aerosphere for the treatment of COPD
AstraZeneca has announced that its Breztri Aerosphere (PT010) budesonide / glycopyrrolate / formoterol fumarate MDI has been approved by the FDA for the treatment of COPD. The FDA had previously issued a complete response letter to AstraZeneca’s NDA for PT010 in the fall of 2019. In August 2019, the company announced that the Phase 3 ETHOS trial of Breztri had … [Read more...] about FDA approves Breztri Aerosphere for the treatment of COPD
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
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
Ferring issues recall of desmopressin nasal sprays
According to the UK's Medicines & Healthcare products Regulatory Agency (MHRA), Ferring Pharmaceuticals has recalled multiple batches of Desmospray 0.1 mg/ml desmopressin, Aspire branded desmopressin 0.1 mg/ml, and Octim desmopressin 1.5 mg/ml nasal sprays "due to a lower volume of solution being observed in the bottles, and out of specification results for the … [Read more...] about Ferring issues recall of desmopressin nasal sprays
Enerzair Breezhaler approved in EC with optional Propeller Health sensor and app
Novartis's Enerzair Breezhaler (QVM149) indacaterol / glycopyrronium / mometasone furoate DPI has been approved by the EC for the treatment of asthma, the company said. The inhaler can now be marketed with an optional Propeller Health sensor and mobile app throughout the EU, and in the UK, Iceland, Norway, and Liechtenstein. The EMA's Committee for Medicinal Products … [Read more...] about Enerzair Breezhaler approved in EC with optional Propeller Health sensor and app
Enerzair and Atectura Breezhalers approved in Japan
The Japanese Ministry of Health, Labour and Welfare has approved two Novartis DPIs -- Enerzair Breezhaler glycopyrronium / indacaterol/ mometasone furoate and Atectura indacaterol / mometasone furoate -- for the treatment of asthma, the company said. The two DPIs were part of a batch of five Novartis drugs approved simultaneously by the MHLW. Sosei Heptares, which … [Read more...] about Enerzair and Atectura Breezhalers approved in Japan
ISAM calls on pharmaceutical industry and regulators to prioritize development of inhaled therapies for COVID-19
Over a dozen well-known OINDP specialists have issued a call for accelerated development of inhaled therapies for COVID-19, with the goal of getting these products to patients faster. Writing to the editor of the Journal of Aerosol Medicine and Pulmonary Drug Delivery, members of the Regulatory and Standardization Issues Networking Group of the International Society … [Read more...] about ISAM calls on pharmaceutical industry and regulators to prioritize development of inhaled therapies for COVID-19