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Teva launches generic version of Perforomist inhalation solution in the US

Teva Pharmaceuticals said that it has launched a generic version of Perforomist formoterol fumarate inhalation solution for the treatment of COPD in the US. Perforomist was approved by the FDA in 2007; Teva first submitted an ANDA for its generic inhalation solution in 2009; the Teva ANDA was tentatively approved in May 2020; and Mylan's covering Perforomist expired … [Read more...] about Teva launches generic version of Perforomist inhalation solution in the US

Phase 2 study of Theravance’s nezulcitinib inhaled pan-JAK inhibitor for COVID-19 fails to meet primary endpoint

Theravance Biopharma said that a Phase 2 study of its inhaled nezulcitinib (TD-0903) pan-JAK inhibitor in hospitalized COVID-19 patients failed to meet its primary endpoint of respiratory failure free days at Day 28. The study did demonstrate some improvement in all-cause mortality, and in patients with C-reactive protein levels below 150 mg/L, nezulcitinib … [Read more...] about Phase 2 study of Theravance’s nezulcitinib inhaled pan-JAK inhibitor for COVID-19 fails to meet primary endpoint

PARI Pharma names Stefan Seemann as its new President

PARI Pharma has named Stefan Seemann as its new President, effective July 1, 2021. Seeman will take over from Martin Knoch, who is retiring after more than 30 years at PARI Pharma, where he oversaw development of the company's eFlow nebulizer technology. Seeman, who joined PARI Pharma in 2000 after several years at Boehringer Inhgelheim, was most recently VP for eFlow … [Read more...] about PARI Pharma names Stefan Seemann as its new President

Valeo launches Enerzair Breezhaler and Atectura Breezhaler in Canada

 Valeo Pharma has announced the launch of the Enerzair Breezhaler indacaterol / glycopyrronium / mometasone furoate and Atectura Breezhaler indacaterol / mometasone furoate DPIs in Canada. The company acquired Canadian rights to the two Novartis dry powder inhalers in March 2021. Enerzair (QVM149) and Atectura (QMF149) are also approved in Europe and in … [Read more...] about Valeo launches Enerzair Breezhaler and Atectura Breezhaler in Canada

Incannex signs agreement with Vectura for preclinical development of its inhaled CBD/isoflurane for the treatment of TBI

Inhalation CDMO Vectura has announced an agreement to provide preclinical development services for Incannex Healthcare's IHL-216A CBD/isoflurane, which Incannex is developing for the treatment of traumatic brain injury. In addition to performing screening, stability, and optimization studies, Vectura will manufacture the IHL-216A needed for toxicology studies. Monash … [Read more...] about Incannex signs agreement with Vectura for preclinical development of its inhaled CBD/isoflurane for the treatment of TBI

Oyster Point initiates Phase 2 trial of OC-01 varenicline nasal spray for neurotrophic keratopathy

Oyster Point Pharma has announced the initiation of the OLYMPIA Phase 2 clinical trial of its OC-01 varenicline nasal spray for the treatment of neurotrophic keratopathy. The company's NDA for OC-01 for the treatment of dry eye disease is currently under review by the FDA. The OLYMPIA study is expected to enroll approximately 100 patients with Stage 1 neurotrophic … [Read more...] about Oyster Point initiates Phase 2 trial of OC-01 varenicline nasal spray for neurotrophic keratopathy

ENA Respiratory gets AU$32 million for development of INNA-051 antiviral nasal spray for COVID-19

ENA Respiratory said that it has raised up to AU$32 million for development of its INNA-051 pegylated TLR2/6 agonist nasal spray for the prevention of respiratory viruses, including COVID-19, and plans to initiate a Phase 1 study of the nasal spray within a few weeks. In September 2020, the company announced a preclinical study demonstrated that INNA-051 reduced … [Read more...] about ENA Respiratory gets AU$32 million for development of INNA-051 antiviral nasal spray for COVID-19