Liquidia Corporation announced that it has initiated the ASCENT open-label safety and tolerability study of Yutrepia (LIQ861) treprostinil DPI in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). The 52-week study is expected to enroll 60 PH-ILD patients. The FDA tentatively approved Yutrepia for the treatment of pulmonary … [Read more...] about Liquidia announces initiation of safety and tolerability study of Yutrepia in PH-ILD patients and provides update on L606 liposomal treprostinil inhalation suspension
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US Senate committee launches investigation of inhaler prices
Members of the United States Senate Committee on Health, Education, Labor, and Pensions (HELP) have sent letters to the CEOs of AstraZeneca, Boehringer Ingelheim, GSK, and Teva asserting that "There is no reason for inhalers to be so expensive" and that each company "has manipulated the regulatory system to extend its monopolies over its inhaler products." The letters … [Read more...] about US Senate committee launches investigation of inhaler prices
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
Theravance says Phase 4 trial fails to demonstrate superiority to Yupelri inhalation solution over Spiriva HandiHaler for the treatment of severe COPD
Theravance Biopharma announced that the Phase 4 PIFR-2 study of nebulized Yupelri revefenacin inhalation solution versus Spiriva HandiHaler tiotropium DPI in patients with severe to very severe COPD failed to demonstrate any significant difference in the improvement in lung function between the two arms. The company announced the initiation of the 12-week Phase 4 … [Read more...] about Theravance says Phase 4 trial fails to demonstrate superiority to Yupelri inhalation solution over Spiriva HandiHaler for the treatment of severe COPD
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
NanoPhoria publishes data on the efficacy of its inhaled lung-to-heart therapy in a pig model
Italian start-up NanoPhoria has announced the publication of an article titled “Lung-to-Heart Nano-in-Micro Peptide Promotes Cardiac Recovery in a Pig Model of Chronic Heart Failure” in the Journal of the American College of Cardiology (JACC). The study, which evaluated a dry powder inhalation formulation of mimetic peptide loaded onto calcium phosphate nanoparticles … [Read more...] about NanoPhoria publishes data on the efficacy of its inhaled lung-to-heart therapy in a pig model
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
FDA issues Refuse to File letter in response to Milestone’s NDA for etripamil nasal spray
According to Milestone Pharmaceuticals, the FDA has refused to file the company's NDA for etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT) and has "requested clarification about the time of data recorded for adverse events" during Phase 3 trials. Milestone submitted the NDA in October 2023. Milestone initiated the Phase 3 … [Read more...] about FDA issues Refuse to File letter in response to Milestone’s NDA for etripamil nasal spray
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