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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

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

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