Nemera and Nipro Pharma Packaging have announced the conclusion of compatibility testing of Nemera’s UniSpray nasal pump with Nipro’s unit dose "microvials." According to the companies, the tests demonstrated complete compatibility and meet requirements for reliability and dose delivery. Nemera announced the launch of the UniSpray single metered dose nasal pump, … [Read more...] about Nemera and Nipro announce compatibility of Nemera’s UniSpray nasal pump and Nipro’s unit dose vials
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Emergent BioSolutions acquires US and Canadian rights to Hikma’s Kloxxado naloxone nasal spray
Emergent BioSolutions announced that it has signed an agreement to acquire marketing rights to Hikma Pharmaceuticals’ Kloxxado naloxone nasal spray in the US and Canada. Kloxxado, which delivers an 8 mg dose, was approved by the FDA for the reversal of opioid overdose in September 2021. Emergent previously acquired Narcan nasal spray, which delivers a 4 mg dose of … [Read more...] about Emergent BioSolutions acquires US and Canadian rights to Hikma’s Kloxxado naloxone nasal spray
Vistagen initiates Phase 2 repeat dose study of fasendiol nasal spray
Vistagen has announced the initiation of a Phase 2 repeat dose study of fasedienol nasal spray, which the company is developing for the treatment of social anxiety disorder. The Phase 3 PALISADE-3 and PALISADE-4 trials of fasendiol for that indication are ongoing. According to Vistagen, the design of the Phase 2 repeat dose trial is basically the same as the … [Read more...] about Vistagen initiates Phase 2 repeat dose study of fasendiol nasal spray
Orexo says study demonstrated that OX640 intranasal dry powder epinephrine is absorbed faster in subjects with allergic rhinitis
Orexo has announced topline results from its OX640-002 PK/PD study of OX640 intranasal dry powder epinephrine in people with allergic rhinitis. According to the company, the study, which was initiated in October 2024, demonstrated that absorption of OX640 occurred significantly faster in subjects with allergic rhinitis symptoms than in those without rhinitis symptoms. … [Read more...] about Orexo says study demonstrated that OX640 intranasal dry powder epinephrine is absorbed faster in subjects with allergic rhinitis
DFE Pharma adds services for DPIs at Center of Excellence in Hyderabad
Lactose supplier DFE Pharma has announced the availability of analytical services for dry powder inhaler formulations at its Closer to the Formulator (C2F) Center of Excellence in Hyderabad, India, in response to growing demand. According to DFE, the center opened in 2022 but only offered services for oral solid dosage forms until now. Newly available services at … [Read more...] about DFE Pharma adds services for DPIs at Center of Excellence in Hyderabad
Lonza to develop spray dried formulations of a dry powder intranasal biologic for Iconovo
Spray drying experts Lonza will develop spray dried dry powder formulations for delivery by Iconovo's ICOone Nasal device, the companies announced. According to the announcement, the collaboration involves "a reformulated substance for obesity." In May 2024, Iconovo said that it intended to develop inhaled GLP-1 receptor agonists for the treatment of … [Read more...] about Lonza to develop spray dried formulations of a dry powder intranasal biologic for Iconovo
Rein Therapeutics announces name change, upcoming Phase 2 trial of LTI-03 DPI for IPF
A Texas-based company founded as Lung Therapeutics in 2013 and acquired by Aileron Therapeutics in 2023 announced that it has now changed its name to Rein Therapeutics. Lung Therapeutics spun off TFF Pharmaceuticals in 2018 to develop dry powders based on thin film freezing technology licensed from the University of Texas. Rein Therapeutics President and CEO … [Read more...] about Rein Therapeutics announces name change, upcoming Phase 2 trial of LTI-03 DPI for IPF
GH Research says it has completed studies related to IND hold on GH001 inhaled mebufotenin and announces results of Phase 2a trials
Irish biopharm company GH Research said that it has completed inhalation toxicology studies of GH001 inhaled mebufotenin (5-MeO-DMT) necessary to address the FDA's 2023 clinical hold on an IND that the company had submitted for a Phase 1 study of GH001 for the treatment of treatment-resistant depression. In addition, the company announced that 2 Phase 2a proof of … [Read more...] about GH Research says it has completed studies related to IND hold on GH001 inhaled mebufotenin and announces results of Phase 2a trials
Leyden Labs raises $70 million for development of its intranasal vaccine platform
Intranasal vaccine developer Leyden Laboratories announced the closing of a $70 million funding round, with proceeds going to support development of prophylactic nasal sprays based on the company's "Mucosal Protection Platform." Leyden Labs, which initiated a Phase 1 trial of its lead candidate, PanFlu intranasal CR9114 anti-hemagglutinin stem human antibody, in … [Read more...] about Leyden Labs raises $70 million for development of its intranasal vaccine platform
Aer Therapeutics initiates Phase 2a trial of inhaled fexlamose (AER-01) in COPD patients
Aer Therapeutics has announced the initiation of the AER-01-002 Phase 2a proof-of-concept study of nebulized fexlamose (formerly AER-01) in COPD patients with high mucus plug scores. The trial is expected to enroll 100 patients with moderate-to-severe COPD who will receive daily fexlamose for 28 days. Aer said that it expects to have top-line data available in January … [Read more...] about Aer Therapeutics initiates Phase 2a trial of inhaled fexlamose (AER-01) in COPD patients