According to Liquidia Corporation, United Therapeutics has filed a new patent infringement suit in the US District Court for the District of Delaware in response to Liquidia's submission of an sNDA for Yutrepia treprostinil DPI to add pulmonary hypertension associated with interstitial lung disease (PH-ILD) as an indication. Yutrepia was tentatively approved … [Read more...] about United Therapeutics files new suit alleging that Liquidia’s Yutrepia treprostinil DPI infringes a patent covering Tyvaso
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Krystal Biotech gets orphan drug designation for KB408 inhaled gene therapy for AAT deficiency
According to Krystal Biotech, the FDA has granted orphan drug designation to the company's KB408 nebulized gene therapy for the treatment of alpha-1 antitrypsin (AAT) deficiency. Krystal, which is also developing inhaled gene therapies for the treatment of cystic fibrosis (KB407) and solid tumors (KB707), says that KB408 is intended to deliver 2 copies of the … [Read more...] about Krystal Biotech gets orphan drug designation for KB408 inhaled gene therapy for AAT deficiency
Insmed announces results of the Phase 3 ARISE study of Arikayce for NTM lung infections caused by MAC
Insmed announced that the Phase 3 ARISE study of Arikayce amikacin liposome inhalation suspension demonstrated the effectiveness of the QOL-B questionnaire for patient-reported outcomes. The ARISE study of Arikayce in patients with nontuberculous mycobacterial (NTM) lung infection caused by Mycobacterium avium complex (MAC) was initiated in December 2020 with the … [Read more...] about Insmed announces results of the Phase 3 ARISE study of Arikayce for NTM lung infections caused by MAC
ENA Respiratory announces new funding, personnel to support Phase 2b study of INNA-051 antiviral nasal spray
ENA Respiratory announced preparations for a Phase 2b study of its INNA-051 pegylated TLR2/6 agonist nasal spray for the prevention of respiratory viruses in people aged 65 and older will be supported by an additional $3.8 million from the US Department of Defense (DOD) as well as by several new clinical appointments. In January 2023, the company said that it had … [Read more...] about ENA Respiratory announces new funding, personnel to support Phase 2b study of INNA-051 antiviral nasal spray
Orexo gets US patent related to its OX640 intranasal dry powder epinephrine
According to Orexo, the United States Patent and Trademark Office (USPTO) has issued the company US patent No. 11,737,980 ("Pharmaceutical composition for drug delivery") which provides protection for OX640 epinephrine nasal powder. Orexo notes that it also received a European patent covering OX640 in 2022. The company announced Phase 1 results for OX640 in October … [Read more...] about Orexo gets US patent related to its OX640 intranasal dry powder epinephrine
PureIMS announces planned Phase 1 trial of Levodopa Cyclops
PureIMS has announced that it intends to initiate a dose-finding study of its Levodopa Cyclops DPI titled "A pilot open-label, randomized, crossover, comparative bioavailability study of levodopa administered via Levodopa Cyclops (test product) relative to Inbrija (reference product) in healthy adult subjects" by the end of this year. In April 2023, PureIMS announced … [Read more...] about PureIMS announces planned Phase 1 trial of Levodopa Cyclops
Immune Biosolutions reports results from Phase 1 and 2 trials of IBIO123 inhaled antibody therapy for COVID-19
Immune Biosolutions has announced the publication of results from Phase 1 and 2 trials of the company's IBIO123 inhaled antibody therapy in patients with COVID-19 in The Lancet Infectious Diseases. Immune Bio announced the initiation of the Phase 1 trial in October 2021. According to the journal article, the Phase 2 study was stopped early because COVID-19 became … [Read more...] about Immune Biosolutions reports results from Phase 1 and 2 trials of IBIO123 inhaled antibody therapy for COVID-19
Honeywell and Recipharm partner on development of MDIs using Solstice Air HFO-1234ze(e) propellant
Propellant manufacturer Honeywell and CDMO Recipharm are partnering on development of MDIs formulated with Honeywell’s Solstice Air lower-GWP propellant, the companies said. Honeywell announced in October 2022 that it had started large scale manufacturing of medical grade Solstice Air HFO-1234ze(e) for use in metered dose inhalers and has previously announced a … [Read more...] about Honeywell and Recipharm partner on development of MDIs using Solstice Air HFO-1234ze(e) propellant
FDA issues warning letter to AstraZeneca over efficacy claims for Breztri MDI
The FDA issued a warning letter to AstraZeneca dated August 4, 2023 that cites multiple "false or misleading claims and/or representations" about the efficacy of the company's Breztri Aerosphere (PT010) budesonide / glycopyrrolate / formoterol fumarate MDI. Breztri was approved by the FDA for the treatment of COPD in July 2020. According to the warning letter, the … [Read more...] about FDA issues warning letter to AstraZeneca over efficacy claims for Breztri MDI
Lupin launches its generic tiotropium bromide DPI in the US
Lupin has launched its generic version of Spiriva HandiHaler tiotropium bromide DPI for the treatment of COPD in the US, the company said. The FDA approved Lupin's ANDA for the tiotropium bromide inhaler in June 2023. The generic of Spiriva HandiHaler was recently approved in Australia and has also been approved in the UK and Canada. Lupin CEO Vinita Gupta … [Read more...] about Lupin launches its generic tiotropium bromide DPI in the US