Opiant Pharmaceuticals said that it has filed the first part of a 505(b)(2) NDA for OPNT003 intranasal nalmefene for the treatment of opioid overdose and that it expects to complete the submission later this year. The company recently announced that a PD study of OPNT003 met its primary endpoint. Opiant President and CEO Roger Crystal commented, "The opioid … [Read more...] about Opiant begins rolling NDA submission for OPNT003 intranasal nalmefene
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FDA clears IND for Codagenix intranasal RSV vaccine
According to Codagenix, the FDA has cleared the company's IND for CodaVax-RSV intranasal live-attenuated vaccine (LAIV) for the prevention of respiratory syncytial virus (RSV) infection, and plans are in progress for a Phase 1 study in children aged 6 months to 5 years. Codagenix previously conducted a Phase 1 study of CodaVax-RSV in adults aged … [Read more...] about FDA clears IND for Codagenix intranasal RSV vaccine
FDA accepts Avillion’s NDA for PT027 albuterol/budesonide MDI
According to Avillion, the FDA has accepted the company's NDA for AstraZeneca's PT027 albuterol/budesonide MDI for the treatment of asthma in patients aged 4 and older for review. In March 2018, Avillion announced that it was partnering with Pearl Therapeutics on development of PT027; Pearl was acquired by AstraZeneca in 2013. AstraZeneca has an option to … [Read more...] about FDA accepts Avillion’s NDA for PT027 albuterol/budesonide MDI
Adherium names Tara Creaven-Capasso as VP of Quality, Regulatory and Clinical Affairs
Hailie inhaler monitoring system maker Adherium has announced the appointment of Tara Creaven-Capasso as VP of Quality, Regulatory and Clinical Affairs. Creaven-Capasso has been a long-time regulatory affairs consultant; earlier in her career, she also held QA positions at several companies, including Xoma and Medtronic. Adherium received 510(k) clearance for its next … [Read more...] about Adherium names Tara Creaven-Capasso as VP of Quality, Regulatory and Clinical Affairs
Gerresheimer to manufacture ICOone DPI for Phase 3 trials of ISR’s intranasal COVID-19 vaccine
Gerresheimer has announced that it will manufacture supplies of Iconovo's IcoOne dry powder inhaler for Phase 3 trials of ISR's intranasal COVID-19 vaccine and has started the design process for molding and manufacturing the device. In March 2021, Iconovo announced that it would develop an inhaled vaccine for ISR, and in July 2021, Icovono said that it was developing … [Read more...] about Gerresheimer to manufacture ICOone DPI for Phase 3 trials of ISR’s intranasal COVID-19 vaccine
Upperton Pharma Solutions announces plans to build new facility
CDMO Upperton Pharma Solutions, which recently launched a new nasal delivery development platform, has announced that it will invest £15 million in a new 50,000 sq ft facility in Nottingham, UK that will include new laboratory space and 10 times more GMP manufacturing space than the company has currently. The new facility will also have the ability to handle highly … [Read more...] about Upperton Pharma Solutions announces plans to build new facility
FDA approves Tyvaso DPI for the treatment of PAH and PH-ILD
United Therapeutics has announced the FDA's approval of its NDA for Tyvaso treprostinil DPI for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). United Therapeutics licensed Treprostinil Technosphere from MannKind Corporation in September 2018 and submitted the NDA for Tyvaso DPI in … [Read more...] about FDA approves Tyvaso DPI for the treatment of PAH and PH-ILD
Blue Lake’s intranasal RSV vaccine gets Fast Track designation
According to CyanVac subsidiary Blue Lake Biotechnology, the FDA has granted Fast Track designation for the company's BLB-201 intranasal vaccine against respiratory syncytial virus (RSV) in children under 2 and adults over 60. The vaccine is based on an attenuated strain of canine parainfluenza virus (PIV5). In March 2022, Blue Lake announced that the FDA had … [Read more...] about Blue Lake’s intranasal RSV vaccine gets Fast Track designation
Lonza announces expansion of DPI testing capacity
CDMO Lonza has announced that it is adding dry powder inhaler testing capabilities at its facility in Tampa, FL, USA for increased DPI development capacity. Lonza, which established a Center of Excellence for DPI particle engineering and formulation in Bend, OR, USA in 2020, said that the new laboratories in the Florida location will include capabilities for handling … [Read more...] about Lonza announces expansion of DPI testing capacity
FDA accepts Biohaven’s NDA for intranasal zavegepant for the treatment of migraine
According to Biohaven Pharmaceuticals, the FDA has accepted the company's NDA for its zavegepant (BHV-3500) calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the treatment of migraine and has set a PDUFA goal date in the first quarter of 2023. In December 2019, Biohaven announced positive results from a Phase 2/3 pivotal trial of the nasal … [Read more...] about FDA accepts Biohaven’s NDA for intranasal zavegepant for the treatment of migraine