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Neurelis acquires Aegis Therapeutics

US Pharmaceutical company Neurelis, which recently submitted an NDA for Valtoco diazepam nasal spray, has acquired Aegis Therapeutics and its Intravail transmucosal absorption technology, a component of the Valtoco formulation. In addition to Intravail, Aegis Therapeutics offers two other excipients that can be used in nasal formulations, ProTek and Aegis Hydrogels, … [Read more...] about Neurelis acquires Aegis Therapeutics

Proveris Scientific appoints Alberto Correia as VP of Technical Services

Aerosol characterization company Proveris Scientific Corporation, has announced the appointment of Alberto Correia as VP of Technical Services. Correia has held executive positions at a number of companies, including Horizon Technologies, SeqLL, Harvard Apparatus Regenerative Technology (now Biostage), and Cambridge Biomedical. In his new role, Correia will … [Read more...] about Proveris Scientific appoints Alberto Correia as VP of Technical Services

FDA issues revised draft guidances for sumatriptan and zolmitriptan nasal sprays

Revised draft guidances for sumatriptan and zolmitriptan nasal sprays are included in the most recent batch of product-specific guidances for generic drug development issued by the FDA. The agency says that it "publishes these product-specific guidances to foster drug product development, and ANDA submission and approval, ultimately providing increased access to safe, … [Read more...] about FDA issues revised draft guidances for sumatriptan and zolmitriptan nasal sprays

Phase 1 study of Novus Therapeutics’ OP0201 intranasal surfactant gets underway

Novus Therapeutics said that it has initiated a Phase 1 clinical trial of OP0201, an intranasal surfactant that the company is developing for the treatment of otitis media. The 2-week study will evaluate daily administration of 30 mg and 60 mg doses of OP0201, delivered intranasally via MDI, in 30 healthy adults. Earlier this year, the company announced that it had … [Read more...] about Phase 1 study of Novus Therapeutics’ OP0201 intranasal surfactant gets underway

Theravance initiates Phase 1 trial of TD-8236 inhaled JAK inhibitor

According to Theravance Biopharma, the first subject has been dosed in a Phase 1 clinical trial of TD-8236, a JAK inhibitor that the company is developing as a DPI for the potential treatment of asthma, COPD, and other respiratory diseases. The company said that in preclinical studies, TD-8236 has demonstrated inhibition of JAK/STAT cytokines in disease relevant … [Read more...] about Theravance initiates Phase 1 trial of TD-8236 inhaled JAK inhibitor

Phase 3 trial of VR475 inhalation suspension fails to meet primary endpoint, Vectura discontinues development

Vectura has announced that a Phase 3 study of VR475 budesonide inhalation suspension for the treatment of severe uncontrolled asthma in adult and adolescent patients failed to meet its primary endpoint. As a result, the company said that it would discontinue development of VR475 (formerly known as Favolir), which it acquired when it acquired Activaero in … [Read more...] about Phase 3 trial of VR475 inhalation suspension fails to meet primary endpoint, Vectura discontinues development

Pulmatrix announces plans for Phase 2 study of Pulmazole itraconazole DPI

Pulmatrix said that based on final results from a Phase 1/1b study of its Pulmazole (PUR1900) itraconazole DPI, which it is developing for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in asthma patients, the company now plans to begin a Phase 2 trial by the end of the year. The company previously reported top line data from the study showing … [Read more...] about Pulmatrix announces plans for Phase 2 study of Pulmazole itraconazole DPI