Particle engineering company Crystec has announced a new partnership with SignalRx Pharmaceuticals for development of an inhaled dry powder formulation of SignalRx's SF2523 PI3K-BRD4 inhibitor for the treatment of pulmonary fibrosis, lung cancer, and COVID-19. The project is supported by Swiss life sciences investment company ADYA Consulting. According to the … [Read more...] about Crystec and SignalRx partner on development of inhaled P13K-BRD4 inhibitor
News
FDA pre-approval inspection of Liquidia manufacturing facility has been completed
According to Liquidia Corporation, the FDA has completed a pre-approval inspection of Liquidia's facility in Morrisville, North Carolina, USA, where the company will manufacture LIQ861 dry powder treprostinil if approved. No Form 483 observations were issued. The company added that it has received notice that the agency will also require a pre-approval inspection of a … [Read more...] about FDA pre-approval inspection of Liquidia manufacturing facility has been completed
Positive Phase 1 results for Receptor Life Sciences’ RLS103 CBD DPI
Receptor Life Sciences (RLS) has published data from a Phase 1 PK trial of its RLS103 dry powder cannabidiol (CBD) in the Journal of Pharmaceutical Sciences demonstrating significantly greater bioavailability for the inhaled CBD than for Epidiolex oral CBD solution. RLS announced completion of its pre-IND meeting with the FDA in January 2021. Receptor licensed … [Read more...] about Positive Phase 1 results for Receptor Life Sciences’ RLS103 CBD DPI
Cellics partners with HCmed on delivery of inhaled nanosponges
Nebulizer maker HCmed Innovations and Cellics Therapeutics have agreed to collaborate on inhaled delivery of cellular nanosponges as antibacterial and anti-inflammatory therapies. Cellics is currently developing nanosponges based on red blood cells and macrophages, and the company expects to advance its CTI-005 RBC nanosponge into clinical development for the … [Read more...] about Cellics partners with HCmed on delivery of inhaled nanosponges
Virpax says it intends to submit NDA for its MMS019 nasal spray as an OTC anti-viral barrier
Virpax Pharmaceuticals said that it is encouraged by the FDA response to its IND for MMS019 "high-density molecular masking spray" which the company is developing as an anti-viral barrier. According to Virpax, the company now intends to begin clinical development with the goal of submitting an NDA for MMS019 to the FDA's Office of Non-Prescription Drugs. The company … [Read more...] about Virpax says it intends to submit NDA for its MMS019 nasal spray as an OTC anti-viral barrier
Positive results from pilot study of Tiziana’s intranasal Foralumab in mild to moderate COVID-19
Tiziana Life Sciences has published results from a pilot study of its intranasal Foralumab in mild to moderate COVID-19 demonstrating that nasal administration of the human anti-CD3 monoclonal antibody was well tolerated and significantly reduced lung inflammation in non-hospitalized patients. In 2019, the company announced positive Phase 1 results for the intranasal … [Read more...] about Positive results from pilot study of Tiziana’s intranasal Foralumab in mild to moderate COVID-19
Aptar Pharma gets option to acquire Pharmaxis’s Orbital DPI
Aptar Pharma will have 12 months to decide whether to exercise an exclusive option to acquire worldwide rights to Pharmaxis's high payload Orbital dry powder inhaler under a new agreement, the company said. The Orbital DPI, which can deliver up to 400 mg of powder in divided doses, was designed for delivery of Pharmaxis's Bronchitol inhaled mannitol, and Pharmaxis … [Read more...] about Aptar Pharma gets option to acquire Pharmaxis’s Orbital DPI
FDA indicates that Merxin’s MRX004 SMI could be used for generics of Spiriva Respimat
According to a LinkedIn post by generic device maker Merxin, the FDA has indicated that Merxin's MRX004 soft mist inhaler is suitable for an ANDA submission for a generic version of Boehringer Ingelheim's Spiriva Respimat tiotropium bromide SMI. Merxin recently announced that it would sponsor doctoral research at the University of Hertfordshire to support development … [Read more...] about FDA indicates that Merxin’s MRX004 SMI could be used for generics of Spiriva Respimat
Philip Morris acquires Asprihale developer OtiTopic
Philip Morris International (PMI) has acquired inhaled drug developer OtiTopic, as "part of PMI’s strategic plan to leverage its expertise, scientific know-how, and capabilities in inhalation to grow a pipeline of inhaled therapeutics and respiratory drug delivery Beyond Nicotine," the company said. PMI recently announced a £1 billion offer for inhalation CDMO … [Read more...] about Philip Morris acquires Asprihale developer OtiTopic
Ji Xing acquires Chinese rights to two Oyster Point nasal sprays for dry eye
Ji Xing Pharmaceuticals has acquired Chinese development and commercialization rights to Oyster Point Pharma's OC-01 varenicline nasal spray and OC-02 simpinicline nasal spray for the treatment of dry eye disease in a deal that includes a $17.5 million upfront payment and up to $204.8 million in milestone payments and royalties. Earlier this year, Ji Xing acquired … [Read more...] about Ji Xing acquires Chinese rights to two Oyster Point nasal sprays for dry eye