SaNOtize has initiated a Phase 2 study of its nitric oxide nasal spray (NONS) for the treatment of recurrent acute rhinosinusitis, the company said. The trial is expected to enroll 186 patients who will receive either the NO nasal spray or placebo at the beginning of an episode of sinusitis, with time to symptom resolution as a primary endpoint. Previous trials of … [Read more...] about SaNOtize initiates Phase 2 trial of its nitric oxide nasal spray in patients with sinusitis
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Krystal Biotech’s KB707 inhaled gene therapy for the treatment of lung tumors gets Fast Track designation
Krystal Biotech announced that inhaled KB707 gene therapy for the treatment of metastasized tumors in the lung that are not successfully treated with standard therapy has been granted Fast Track designation by the FDA. The FDA had previously granted Fast Track designation to intra-tumoral KB707 for the treatment of melanoma. In July 2023, Krystal announced that it … [Read more...] about Krystal Biotech’s KB707 inhaled gene therapy for the treatment of lung tumors gets Fast Track designation
Oragenics CEO Kimberly Murphy resigns
Oragenics, which describes itself as "a company focused on developing unique, intranasal nanoparticle pharmaceuticals for the treatment of neurological disorders" has announced the resignation of CEO Kimberly Murphy as part of "a mutually agreeable Separation Agreement." The company specified that Murphy's resignation "was not due to any disagreement with the Company … [Read more...] about Oragenics CEO Kimberly Murphy resigns
Catalent adds DPI capsule filling capacity for potent drugs
CDMO Catalent has announced the addition of DPI capsule filling capacity for potent drugs at its facility in the Boston, MA, USA area, including isolators for processing of potent compounds and cleanroom upgrades. According to Catalent, spray drying capacity has also increased, giving the company the largest cGMP manufacturing capacity for DPI capsules. The CDMO … [Read more...] about Catalent adds DPI capsule filling capacity for potent drugs
Adherium announces the appointment of Paul Mastoridis as CEO
Adherium has announced that former Novartis executive Paul Mastoridis will succeed Rick Legleiter as CEO of the Hailie inhaler monitoring system maker. Legleiter recently announced his resignation from the company. Mastoridis was most recently Global Medical Head of Respiratory at Novartis and previously served as a brand director for respiratory at that company. … [Read more...] about Adherium announces the appointment of Paul Mastoridis as CEO
Lupin launches cyanocobalamin nasal spray in US
Lupin announced that it has launched its generic cyanocobalamin nasal spray for the prevention and treatment of vitamin B12 deficiency in the US. The FDA approved the company's ANDA for the 500 mcg/spray intranasal cyanocobalamin in June 2023. The Lupin cyanocobalamin nasal spray is a generic of Par Pharmaceutical's Nascobal nasal spray, which was approved by the … [Read more...] about Lupin launches cyanocobalamin nasal spray in US
Microbion’s pravibismane gets orphan drug designation for NTM indication
Microbion Corporation announced that the FDA has granted orphan drug designation for pravibismane for the treatment of non-tuberculous mycobacterial (NTM) infections. Pravibismane, which Microbion is developing as a topical treatment as well as an inhalation suspension, already had orphan drug designation for the treatment of lung infections in cystic fibrosis … [Read more...] about Microbion’s pravibismane gets orphan drug designation for NTM indication
Kindeva opens new laboratories, launches analytical services business
Kindeva Drug Delivery has announced the opening of a 32,000 sq ft laboratory facility in Woodbury, MN, USA that will be home to the company's new analytical services business unit. According to the announcement, the analytical services offered include medical device, container closure, and extractables and leachables testing. The company said that extractables and … [Read more...] about Kindeva opens new laboratories, launches analytical services business
Defender gets CRL in response to its DPI-386 intranasal scopolamine NDA
Defender Pharmaceuticals announced that the FDA has issued a complete response letter in response to the NDA for DPI-386 scopolamine nasal gel that the company submitted in July 2023. The FDA accepted the NDA for review in September 2023, with a PDUFA goal date of January 26, 2024. Defender President and CEO Barry I. Feinberg commented, “Following our review of … [Read more...] about Defender gets CRL in response to its DPI-386 intranasal scopolamine NDA
Dr. Ferrer BioPharma wins Pharmapack award for its GentleMist nasal delivery technology
The Patient-Centric Design award at CPHI Pharmapack 2024 went to Florida-based Dr. Ferrer BioPharma for its GentleMist nozzle for intranasal delivery devices, which was developed as part of a partnership with researchers at South Dakota State University, Bona Pharma, and the Cleveland Clinic. According to the company, "GentleMist Technology utilizes advanced fluid … [Read more...] about Dr. Ferrer BioPharma wins Pharmapack award for its GentleMist nasal delivery technology