AstraZeneca has announced the US launch of its Airsupra albuterol / budesonide MDI, which was approved by the FDA in January 2023 for the treatment of asthma in people aged 18 and over. Airsupra (PT027) was developed by AstraZeneca subsidiary Pearl Therapeutics. The company points out that the MDI is the only approved SABA/ICS inhaler and the only one that includes … [Read more...] about AstraZeneca launches Airsupra albuterol / budesonide MDI in the US
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Cyrano raises $9 million for continued development of CYR-064 intranasal theophylline for the treatment of hyposmia
Cyrano Therapeutics said that the company will use proceeds from a $9 million Series B financing round to fund an ongoing Phase 2 trial of CYR-064 theophylline nasal spray for the treatment of loss of smell due to viral infection. Cyrano previously announced in December 2020 that it had raised $12.8 million in Series A financing for a Phase 2 trial of CYR-064. In … [Read more...] about Cyrano raises $9 million for continued development of CYR-064 intranasal theophylline for the treatment of hyposmia
Pulmatrix to stop Phase 2b trial of PUR1900 itraconazole DPI; Cipla to take over development
Pulmatrix announced that it will halt a Phase 2b trial of PUR1900 dry powder itraconazole (Pulmazole) in patients with allergic bronchopulmonary aspergillosis (ABPA) that was initiated in February 2023. The company says that the move is part of an amended agreement with Cipla, which has been partnered with Pulmatrix on development of PUR1900 for the treatment of ABPA … [Read more...] about Pulmatrix to stop Phase 2b trial of PUR1900 itraconazole DPI; Cipla to take over development
Essential Pharma acquires European rights to Colobreathe colistimethate sodium DPI from Teva
Essential Pharma announced that it has acquired European rights to Teva's Colobreathe colistimethate sodium inhalation powder from Teva. Colobreathe, which was developed by Forest Laboratories, was approved by the EMA for the treatment of P. aeruginosa infections in cystic fibrosis patients aged 6 and older in 2012. According to Essential, Colobreathe is marketed in … [Read more...] about Essential Pharma acquires European rights to Colobreathe colistimethate sodium DPI from Teva
Atai Life Sciences announces strategic investment in Beckley Psytech
Atai Life Sciences announced that it has invested a total of $50 million to acquire 35.5% of Beckley Psytech, which is developing BPL-003 intranasal synthetic 5-MeO-DMT (mebufotenin). Atai's subsidiary Innaris Bio is developing a gelling excipient for use in intranasal drugs for the treatment of mental health disorders. The deal includes the right of first … [Read more...] about Atai Life Sciences announces strategic investment in Beckley Psytech
MannKind sells 1% royalty in Tyvaso treprostinil DPI for up to $200 million
According to MannKind Corporation, Sagard Healthcare is paying $150 million and a potential milestone payment of as much as $50 million for a 1% royalty on net sales of Tyvaso treprostinil DPI between October 1, 2023 and December 31, 2042. Tyvaso DPI is marketed by United Therapeutics, which licensed Treprostinil Technosphere from MannKind Corporation in September … [Read more...] about MannKind sells 1% royalty in Tyvaso treprostinil DPI for up to $200 million
Firebrick no longer seeking approval of Nasodine nasal spray in Australia
Firebrick Pharmaceuticals announced that it has withdrawn its appeal of a decision by the Therapeutic Goods Administration (TGA), which refused to approve the company's Nasodine povidone-iodine nasal spray as a treatment for the common cold. Firebrick said that the withdrawal was due to "the significant distraction and legal costs associated with proceeding," … [Read more...] about Firebrick no longer seeking approval of Nasodine nasal spray in Australia
Court upholds PTAB ruling invalidating United Therapeutics’ patent at center of suit delaying final approval Liquidia’s Yutrepia treprostinil DPI
According to Liquidia Corporation, the company will immediately take steps toward getting final FDA approval of Yutrepia treprostinil DPI now that the US Court of Appeals has upheld a decision by the Patent Trial and Appeal Board (PTAB) invalidating all of the claims of US Patent No. 10,716,793. Earlier this year, the Court of Appeals upheld a District Court ruling … [Read more...] about Court upholds PTAB ruling invalidating United Therapeutics’ patent at center of suit delaying final approval Liquidia’s Yutrepia treprostinil DPI
Harm Reduction announces availability of RiVive naloxone nasal spray in the US
Non-profit Harm Reduction Therapeutics (HRT) announced that it has filled the first order for RiVive naloxone nasal spray, which was approved by the FDA in July 2023 as an over-the-counter medication for the treatment of opioid overdose. RiVive, which is being manufactured by Catalent at its Morrisville, North Carolina facility, will be more available more broadly in … [Read more...] about Harm Reduction announces availability of RiVive naloxone nasal spray in the US
Vivaldi gets grant to fund preclinical transmission study of its DeltaFlu intranasal universal flu vaccine
Vivaldi Biosciences announced that the Flu Lab has provided a grant to fund a transmission study of the company's DeltaFLU intranasal universal influenza vaccine. According to the company, the study will evaluate the ability of DeltaFlu to protect against transmission of "broadly divergent wild-type influenza type A and B strains" among ferrets. The company noted … [Read more...] about Vivaldi gets grant to fund preclinical transmission study of its DeltaFlu intranasal universal flu vaccine