Liquidia Technologies has announced interim data from the Phase 3 INSPIRE trial of its LIQ861 DPI treprostinil for the treatment of pulmonary arterial hypertension demonstrating that LIQ861 was well-tolerated at doses of up to about 125 μg in PAH patients after two weeks, a safety endpoint requested by the FDA. The company announced initiation of the study in January … [Read more...] about Liquidia announces interim results from Phase 3 INSPIRE trial of inhaled treprostinil
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Nanoform appoints Gonçalo Rebelo de Andrade as Chief of Business Operations
Finnish nanotechnology company Nanoform has named Gonçalo Rebelo de Andrade, former Hovione Business Development Manager for inhalation and respiratory product development, as Chief of Business Operations. The company recently announced that it is building a new 600m2 GMP manufacturing facility in Helsinki. Andrade also served as Managing Director of Hovione … [Read more...] about Nanoform appoints Gonçalo Rebelo de Andrade as Chief of Business Operations
Positive Phase 1 results for Orexo’s intranasal naloxone
Orexo has announced results from a PK study of its OX124 naloxone nasal spray in 20 healthy volunteers that compared 4 development formulations of OX124 to Narcan naloxone nasal spray. According to the company, all 4 formulations of OX124 demonstrated "substantially higher" plasma concentrations of naloxone compared to Narcan, with equal or faster onset times. The … [Read more...] about Positive Phase 1 results for Orexo’s intranasal naloxone
Impel Neuropharma announces results of Phase 1 trial of INP105 intranasal olanzapine
Impel NeuroPharma has announced results from a Phase 1 PK trial of INP105 intranasal olanzapine demonstrating that the intranasal formulation achieved Tmax two times faster than Zyprexa intramuscular olanzapine and ten times faster than Zyprexa Zydis orally disintegrating tablets, with similar Cmax and AUC to the intramuscular formulation and higher plasma levels … [Read more...] about Impel Neuropharma announces results of Phase 1 trial of INP105 intranasal olanzapine
Senzer’s SiDD inhaler wins Good Design Award
Senzer has announced that its breath-activated Systemic inhaled Delivery Device (SiDD) inhaler has won a 2018 Good Design award in the medical category. The Good Design Awards are presented by The Chicago Athenaeum: Museum of Architecture and Design "for the most innovative and cutting-edge industrial, product, and graphiτc designs produced around the world." In … [Read more...] about Senzer’s SiDD inhaler wins Good Design Award
Stem Cell Medicine licenses intranasal MSC-exo technology for the treatment of autism
Biotech company Stem Cell Medicine (SCM) has announced that it licensed intranasal MSC-exo technology for the treatment of autism spectrum disorder (ASD) from Ramot, the Tel Aviv University Business Engagement Center. Preclinical studies have shown that intranasally delivered MSC-exo demonstrated significant improvement in autistic behaviors in a mouse … [Read more...] about Stem Cell Medicine licenses intranasal MSC-exo technology for the treatment of autism
Syqe Medical raises $50 million for inhaler development
According to a report in Israeli financial newspaper Globes, Tel Aviv-based Syqe Medical has raised $50 million in a financing round led by Shavit Capital for continued development of its medicinal plants inhaler. Shavit Capital has posted the news report on its website. The Syqe inhaler delivers metered doses using heat and a controlled flow of air through … [Read more...] about Syqe Medical raises $50 million for inhaler development
FDA approves Inbrija inhaled levodopa for the treatment of Parkinson’s disease
The FDA has approved Acorda's Inbrija levodopa DPI for the treatment of OFF episodes in Parkinson's disease patients taking carbidopa/levodopa, the company said. Inbrija is expected to be available to patients in the US in the first quarter of 2019. Acorda initially submitted a 505(b)(2) NDA for Inbrija in June 2017, and the FDA issued a refuse to file letter in … [Read more...] about FDA approves Inbrija inhaled levodopa for the treatment of Parkinson’s disease
FDA approves ProAir Digihaler
According to Teva, the FDA has approved the company's sNDA for ProAir Digihaler dry powder albuterol smart inhaler for the treatment or prevention of bronchospasm in patients aged 4 and over. The FDA initially approved Teva's ProAir Respiclick albuterol DPI in 2015, and the agency approved ProAir Respiclick for pediatric use in 2016. The company said that a … [Read more...] about FDA approves ProAir Digihaler
NPXe initiates Phase 3 trial of inhaled xenon for post cardiac arrest syndrome
NPXe has announced the enrollment of the first patient in a Phase 3 study of Xenex inhaled xenon gas for the treatment of post cardiac arrest syndrome (PCAS). The FDA granted Fast Track designation to Xenex for this indication earlier this year. The trial is expected to enroll 1,436 cardiac arrest patients and will compare treatment with Xenex over 24 hours in … [Read more...] about NPXe initiates Phase 3 trial of inhaled xenon for post cardiac arrest syndrome