Vast Therapeutics (formerly Novoclem) has announced that Shionogi & Co. was the sole investor in a Series A financing round that will fund pre-clinical and Phase 1 development of the company's dry powder nitric oxide for the treatment of respiratory infections in cystic fibrosis patients, with the expectation of a licensing agreement. The amount of the investment was … [Read more...] about Shionogi invests in inhaled nitric oxide powder developer Vast Therapeutics
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Propeller Health to be acquired by ResMed
Connected health company ResMed has announced it will pay $225 million to acquire inhaler monitoring company Propeller Health. ResMed has previously focused primarily on products for sleep apnea, including continuous positive airway pressure (CPAP) machines, as well as non-invasive ventilation (NIV) devices that can be used by COPD patients. Propeller health will … [Read more...] about Propeller Health to be acquired by ResMed
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
MedPharm appoints Eugene Ciolfi as President and CEO
CDMO MedPharm has announced the appointment of former DPT Laboratories executive Eugene Ciolfi as President and CEO, replacing Co-Founder Andy Muddle, who will remain "in an ambassadorial role." Ciolfi was most recently VP and Site Head at Torrent Pharma. According to MedPharm, Ciolfi will guide the company as it expands into commercial manufacturing and new … [Read more...] about MedPharm appoints Eugene Ciolfi as President and CEO
Tiziana initiates Phase 1 trial of intranasal foralumab
Tiziana Life Sciences has announced that the FDA approved the company's IND for intranasal foralumab human anti-CD3 antibody, and a Phase 1 clinical trial has begun. Tiziana licensed foralumab from Novimmune in 2014 and is developing the nasal formulation for the treatment of neurodegenerative diseases such as multiple sclerosis. The dose escalating trial, … [Read more...] about Tiziana initiates Phase 1 trial of intranasal foralumab
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