North Carolina-based Renovion said that it has raised $8.1 million in a Series A financing round for development of its ARINA-1 nebulized glutathione/bicarbonate/ascorbic acid formulation for the treatment of chronic lung diseases. ARINA-1, which is delivered via the PARI eFlow nebulizer system, has been granted orphan drug designation by the FDA for the treatment of … [Read more...] about Renovion raises $8.1 million for development of inhaled mucolytic
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Tonix Pharmaceuticals acquires intranasal oxytocin from Trigemina
Tonix Pharmaceuticals has announced that it will acquire assets from Trigemina, Inc that include intranasal oxytocin for the treatment of migraine headaches. Trigemina had licensed the nasal spray, now called TNX-1900, from Stanford University, and Tonix will assume that license. Trigemina Chief Medical Officer Shashidar H. Kori said, “We are excited that Tonix … [Read more...] about Tonix Pharmaceuticals acquires intranasal oxytocin from Trigemina
Positive Phase 3 results for Impel’s INP104 intranasal DHE for the treatment of migraine
Impel NeuroPharma has announced that the Phase 3 STOP 301 study of INP104 intranasal dihydroergotamine mesylate (DHE) for the treatment of acute migraine met its primary objectives, with 66.3% of patients experiencing pain relief and 38% experiencing freedom from pain two hours post dose. Pain relief began as early as 15 minutes post dose for 16.3% of patients using … [Read more...] about Positive Phase 3 results for Impel’s INP104 intranasal DHE for the treatment of migraine
Vectura and Aerami partner on development of inhaled imatinib for PAH
Inhalation CDMO Vectura and inhaled drug developer Aerami Therapeutics (formerly Dance Biopharm) have signed an agreement for development of inhaled imatinib for the treatment of pulmonary arterial hypertension (PAH), the companies said. Aerami will pay nothing up front, but will make milestone payments and pay development fees and royalties on any sales. Aerami will … [Read more...] about Vectura and Aerami partner on development of inhaled imatinib for PAH
Inhalation Sciences appoints Daniel Spasic as Chairman of the Board
Inhalation Sciences (ISAB) has named TFS Trial Form Support International Founder Daniel Spasic as Chairman of the Board. Spasic serves on the boards of several other companies, including connected spirometer maker NuvoAir. In May 2019, Inhalation Sciences announced that it intended to validate its PreciseInhale dosing system, which produces aerosols at a specified … [Read more...] about Inhalation Sciences appoints Daniel Spasic as Chairman of the Board
United Therapeutics alleges that Liquidia has infringed on its Tyvaso patents
United Therapeutics has filed a patent infringement suit against Liquidia Technologies in the US District Court for the District of Delaware alleging infringement of US patents 9,604,901 and 9,593,066, which protect Tyvaso treprostinil inhalation solution. Both patents are titled "Process to prepare treprostinil, the active ingredient in Remodulin" and both expire … [Read more...] about United Therapeutics alleges that Liquidia has infringed on its Tyvaso patents
UCB acquires Engage Therapeutics, Staccato alprazolam
UCB said that it is paying $125 million up front, plus up to $145 million in potential milestone payments, to acquire Engage Therapeutics. Engage has a single candidate, Staccato inhaled alprazolam, which is in Phase 2 development for the treatment of epileptic seizures. Engage acquired Staccato alprazolam from Alexza in 2017, and UCB says that it will continue to … [Read more...] about UCB acquires Engage Therapeutics, Staccato alprazolam
Phase 3 trial of Enerzair Breezhaler for uncontrolled asthma meets primary endpoint
Novartis has announced results from the Phase 3b ARGON study of Enerzair Breezhaler (QVM149) indacaterol/glycopyrronium/mometasone for the treatment of uncontrolled asthma, with the data published in the journal Respiratory Medicine. The 24-week study met its primary endpoint, demonstrating non-inferiority of high and medium doses of once-daily Enerzair Breezhaler to … [Read more...] about Phase 3 trial of Enerzair Breezhaler for uncontrolled asthma meets primary endpoint
FDA issues additional product-specific guidances for OINDPs
The FDA has issued new and revised product-specific guidances (PSGs) for a number of OINDPs as of June 3, 2020. The agency also updated its list of planned PSGs for complex generics, adding a number of PSGs for OINDPs to that list. New PSGs issued on June 3 include: Glycopyrrolate/indacaterol maleate inhalation powderRevefenacin inhalation solution Revised … [Read more...] about FDA issues additional product-specific guidances for OINDPs
Intravacc, Wageningen Bioveterinary Research, and Utrecht University partner on intranasal COVID-19 vaccine
Dutch vaccine maker Intravacc has announced that it is partnering with Wageningen Bioveterinary Research (WBVR) and Utrecht University on development of an intranasal Newcastle disease virus (NDV) vector vaccine for the prevention of COVID-19 in humans. The company said that its Vero cell platform, which is FDA approved, would serve as the basis for a scalable … [Read more...] about Intravacc, Wageningen Bioveterinary Research, and Utrecht University partner on intranasal COVID-19 vaccine