In addition to ongoing litigation against Liquidia Corporation alleging infringement of patents covering Tyvaso inhaled treprostinil by Liquidia's Yutrepia treprostinil DPI, United Therapeutics Corporation announced that it is now suing the FDA over its handling of Liquidia's sNDA to add PH-ILD as an indication for Yutrepia. United Therapeutics calls the sNDA … [Read more...] about United Therapeutics sues the FDA alleging improper handling of Liquidia’s sNDA for Yutrepia treprostinil DPI
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ARS Pharma announces results of Neffy intranasal epinephrine study, plans to file response to CRL
ARS Pharmaceuticals said that it intends to file a response to the September 2023 complete response letter to its NDA for Neffy epinephrine nasal spray “early in the second quarter of 2024,” with the response supported by data from a repeat dose study with nasal allergen challenge as requested by the FDA. According to ARS, topline results from the study, which … [Read more...] about ARS Pharma announces results of Neffy intranasal epinephrine study, plans to file response to CRL
LTR Pharma initiates BE study of Spontan vardenafil nasal spray
LTR Pharma has announced the initiation of a bioequivalence study of its Spontan vardenafil nasal spray, which the company is developing for the treatment of erectile dysfunction. According to LTR, the study will compare a single dose of Spontan, 5 mg (2 sprays of 2.5 mg each) to 10 mg tablets of vardenafil in healthy adult males. The company says that it intends to … [Read more...] about LTR Pharma initiates BE study of Spontan vardenafil nasal spray
Apotex recalls two lots of APO-Mometasone nasal spray
Health Canada has announced that Apotex is recalling 2 lots of its mometasone nasal spray, a generic of Nasonex, due to possible contamination with Burkholderia cepacia complex. Lot TX5343 has an expiration date of September 2025, and lot TZ2586 has an expiration date in October 2025. APO-Mometasone nasal spray is approved in Canada for the treatment of allergies … [Read more...] about Apotex recalls two lots of APO-Mometasone nasal spray
Q&A with Copley’s Clair Brooks on in vitro testing for LGWP MDI reformulation
Copley Application Specialist Clair Brooks discusses new EMA guidance on data requirements associated with the transition to low global warming potential (LGWP) propellants in metered dose inhalers and strategies for the successful application of in vitro testing within this context. How does the 2023 EMA Q&A clarify data requirements for the LGWP transition … [Read more...] about Q&A with Copley’s Clair Brooks on in vitro testing for LGWP MDI reformulation
SaNOtize initiates Phase 2 trial of its nitric oxide nasal spray in patients with sinusitis
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
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