Avalyn Pharma has published data from its Phase 1b ATLAS study evaluating the safety of AP01 nebulized pirfenidone in patients with idiopathic pulmonary fibrosis over 72 weeks. In the article, the authors report that treatment-related adverse events were mild-to-moderate and less frequent than side effects associated with oral pirfenidone. They also reported that … [Read more...] about Avalyn reports data from Phase 1b study of AP01 inhaled pirfenidone in IPF patients
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In Memoriam: Charles G. Thiel
Charles G. Thiel, one of the most influential scientists working in respiratory drug delivery over the past 7 decades, passed away on March 10, 2023 at the age of 94. In 1956, Thiel and co-workers at Riker Laboratories developed the first pressurized metered dose inhaler for delivery of medication to the lungs. Following the 1970 acquisition of Riker by 3M (now … [Read more...] about In Memoriam: Charles G. Thiel
Catalent to manufacture HRT’s RiVive naloxone nasal spray
Catalent and Harm Reduction Therapeutics (HRT) announced that they have signed a commercial supply agreement for the manufacture of HRT's RiVive intranasal naloxone. The news comes shortly after HRT said that it would receive an additional $9 million in funding from Purdue Pharma that would be used to prepare for possible commercialization of RiVive. The FDA … [Read more...] about Catalent to manufacture HRT’s RiVive naloxone nasal spray
Harm Reduction Therapeutics to get an additional $9 million from Purdue for development of RiVive naloxone nasal spray
According to Harm Reduction Therapeutics (HRT), the court handling the bankruptcy of Purdue Pharma has approved an additional $9 million in Purdue funds to be used by HRT to prepare for possible commercialization of RiVive intranasal naloxone. HRT notes that "neither Purdue nor any of its creditors will receive any revenues, royalties, or profits associated with … [Read more...] about Harm Reduction Therapeutics to get an additional $9 million from Purdue for development of RiVive naloxone nasal spray
Vistagen announces results from Phase 3 safety trial of fasedienol (PH94B) nasal spray for social anxiety
Vistagen said that a Phase 3 open label safety study of fasedienol (PH94B, aloradine) nasal spray for the treatment of social anxiety disorder (SAD) found that up to 4 daily doses of 3.2 µg was well-tolerated, with no new safety findings. The company said that on the secondary endpoint of change from baseline on the Liebowitz Social Anxiety Scale (LSAS), "Analysis of … [Read more...] about Vistagen announces results from Phase 3 safety trial of fasedienol (PH94B) nasal spray for social anxiety
Firebrick Pharma restarts Phase 3 trial of Nasodine nasal spray for the common cold
Firebrick Pharma announced that it is re-starting a Phase 3 clinical trial of Nasodine povidone-iodine nasal spray as the 2023 common cold season begins in the Southern Hemisphere. According to the company, the trial, which is taking place in Australia and South Africa, was paused for the summer after having fulfilled half of its recruitment goal during the 2022 cold … [Read more...] about Firebrick Pharma restarts Phase 3 trial of Nasodine nasal spray for the common cold
Allermi raises $3.5 million for direct-to-consumer customized nasal spray
US start-up Allermi said that it has raised $3.5 million in a seed round led by Nelstone Ventures for "the world’s first custom approach offered by Allermi that combines and adjusts the doses of multiple clinically-proven medications into one nasal spray bottle to address patients’ specific symptoms." The company says that its nasal spray service is currently … [Read more...] about Allermi raises $3.5 million for direct-to-consumer customized nasal spray
Stevanato Group to supply syringes for Recipharm’s Resyca syringe-based SMIs
The Stevanato Group has announced that it will manufacture pre-fillable glass syringes for Recipharm's Resyca pre-filled syringe soft mist inhalers for the delivery of biologics. According to Stevanato Group, the interior of the Alba glass syringe has a silicone oil-based coating for improved particle release. The Resyca SMI is the product of a 2020 joint … [Read more...] about Stevanato Group to supply syringes for Recipharm’s Resyca syringe-based SMIs
RDD Europe 2023 returns to Antibes
RDD Europe 2023, organized by RDD Online and Aptar Pharma, returns to Antibes, France, May 2-5 at the Palais des Congrès Antipolis. Richard Dalby of RDD Online says that conference center (previously called the Palais des Congrès Antibes) proved popular with attendees at RDD Europe 2015 and 2017, which took place at the same venue. Dalby expects that attendance will … [Read more...] about RDD Europe 2023 returns to Antibes
Phase 2a study of Aridis’s AR-501 inhaled gallium in CF patients meets primary and secondary endpoints
Aridis Pharmaceuticals has announced that a Phase 2a study of the company's AR-501 nebulized gallium in cystic fibrosis patients with P. aeruginosa lung infections met its primary and secondary endpoints, with all 3 dose levels tested being well tolerated. According to Aridis, uptake of AR-501 in the respiratory track was up to 10 times higher than previously reported … [Read more...] about Phase 2a study of Aridis’s AR-501 inhaled gallium in CF patients meets primary and secondary endpoints