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ReCode Therapeutics initiates Phase 1 trial of RCT2100 inhaled mRNA therapy for CF

ReCode Therapeutics has announced the initiation of a Phase 1 safety and tolerability study of RCT2100 inhaled CFTR mRNA-based therapy, which the company is developing for cystic fibrosis patients who do not benefit from CFTR modulators. The study is expected to enroll 32 healthy adults and will evaluate a single dose of nebulized RCT2100 against placebo. According … [Read more...] about ReCode Therapeutics initiates Phase 1 trial of RCT2100 inhaled mRNA therapy for CF

United Therapeutics sues the FDA alleging improper handling of Liquidia’s sNDA for Yutrepia treprostinil DPI

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

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

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