According to Liquidia Corporation, United Therapeutics has agreed to a court judgment finding that Liquidia did not infringe United Therapeutic's US Patent No. 9,604,901. In October 2021, an inter partes review by the US Patent Trial and Appeal Board (PTAB) determined that 7 of the 9 claims in that patent were invalid. United Therapeutics initially filed suit … [Read more...] about Only one patent remains in contention in the United Therapeutics effort to delay final FDA approval of Liquidia’s Yutrepia treprostinil DPI
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EnBiotix raises $11 million in financing round led by Vectura for further development of ColiFin, murepavidin
EnBiotix, which is in the process of merging with inhaled murepavadin developer Polyphor, announced that it has raised $11 million in a financing round led by inhaled drug CDMO Vectura. Sanford Biosciences and the Cystic Fibrosis Foundation (CFF) also contributed to the financing, which will fund further development of ColiFin nebulized colistimethate sodium in … [Read more...] about EnBiotix raises $11 million in financing round led by Vectura for further development of ColiFin, murepavidin
Teva, Sandoz launch generics of Narcan naloxone nasal spray in US
Both Teva and Sandoz have announced launches of generic naloxone nasal spray for the reversal of opioid overdose in the US, with Teva claiming first-to-market status. The Sandoz version is an authorized generic of Emergent BioSolution's Narcan nasal spray. Teva's version of Narcan was approved by the FDA in April 2019. Opiant initially developed Narcan nasal … [Read more...] about Teva, Sandoz launch generics of Narcan naloxone nasal spray in US
Australian researchers get $4.2 million grant for trial of intranasal heparin for COVID-19
According to Australian healthcare system Northern Health, the government of the state of Victoria will provide a $4.2 million grant to the University of Melbourne and Monash University to fund a clinical trial of intranasal heparin for the prevention and treatment of COVID-19. The Intra Nasal HEpaRin Trial (INHERIT) trial, which will be run by Northern Health, is … [Read more...] about Australian researchers get $4.2 million grant for trial of intranasal heparin for COVID-19
Aridis says its inhaled mAb candidate can neutralize all SARS-CoV-2 variants, including Omicron, plus additional coronaviruses
Aridis Pharmaceuticals said that in vitro testing has demonstrated that its AR-701 monoclonal antibody (mAb) cocktail AR-701 has the ability to neutralize all SARS-CoV-2 variants, including Omicron, as well as the coronaviruses that cause SARS, MERS, and the common cold. The company also said that AR-701 is expected to provide protection against those viruses for 6 … [Read more...] about Aridis says its inhaled mAb candidate can neutralize all SARS-CoV-2 variants, including Omicron, plus additional coronaviruses
ISAB announces positive results from PreciseInhale clinical trial
According to Inhalation Sciences (ISAB), topline data from a clinical trial of ISAB’s PreciseInhale aerosol generating system successfully demonstrated that the system is capable of targeting a dose to a specific lung region and that the dosing from PreciseInhale is more precise than doses delivered from a standard inhaler. The trial, which enrolled 12 healthy … [Read more...] about ISAB announces positive results from PreciseInhale clinical trial
Phase 1 trial of inhaled murepavadin gets underway
Polyphor and EnBiotix have announced the initiation of Phase 1 trial of nebulized murepavadin in healthy volunteers; Polyphor had announced approval of a Phase 1 study by the MHRA in December 2020. The murepavadin inhalation solution, which is delivered via the PARI eFlow nebulizer, is in development for the treatment of P. aeruginosa lung infections in cystic … [Read more...] about Phase 1 trial of inhaled murepavadin gets underway
DDL 2021 tackled timely issues
The 2021 Drug Delivery to the Lungs conference featured a variety of topics of particular interest to the OINDP community in 2021, including COVID-19, digitalization, nasal drug delivery, and reducing the environmental impact of MDIs, as well as how to deal with the tobacco industry's entry into the field. In addition, topics of perennial interest such as formulation … [Read more...] about DDL 2021 tackled timely issues
H&T Presspart to market Biocorp’s Inspair MDI sensor
Device maker H&T Presspart has acquired the rights to market Biocorp’s Inspair inhaler sensor, the two companies have announced. The Inspair sensor, which fits onto standard metered dose inhalers, records inhaler usage data; provides audio and visual feedback on the patient's inhalation technique; and can be reused for up to two years. H&T Presspart will … [Read more...] about H&T Presspart to market Biocorp’s Inspair MDI sensor
Aerovate initiates Phase 2b/3 trial of AV-101 inhaled imatinib for PAH
Aerovate Therapeutics has initiated a Phase 2b/3 trial of its AV-101 imatinib DPI for the treatment of pulmonary arterial hypertension (PAH), the company said. The IMPAHCT trial is expected to enroll 462 PAH patients; the Phase 2b portion of the trial will evaluate three doses of AV-101 versus placebo to select a dose for the Phase 3 portion. Topline results from the … [Read more...] about Aerovate initiates Phase 2b/3 trial of AV-101 inhaled imatinib for PAH