Nasal drug developer Leyden Laboratories announced that former Moderna vaccine development executive Jintanat Ananworanich has joined the company as Chief Medical Officer. Ananworanich was most recently Executive Director of clinical development at Moderna, and her previous experience includes roles as Clinical Development Leader at the Bill and Melinda Gates Medical … [Read more...] about Leyden Labs names Jintanat Ananworanich as new Chief Medical Officer
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TFF Pharmaceuticals partners with Emory University on mRNA-based antiviral DPI with BARDA funding
TFF Pharmaceuticals announced that it will study the feasibility of formulating Emory University's mRNA-based Cas13a antiviral for the treatment of SARS-CoV-2 and influenza A and B as a dry powder using the company's thin film freezing technology. Funding for the study is provided by the Biomedical Advanced Research and Development Authority (BARDA) as part of its … [Read more...] about TFF Pharmaceuticals partners with Emory University on mRNA-based antiviral DPI with BARDA funding
Human Factors (HF) Considerations for Generic Inhalers Using Off-the-shelf Devices
By Yvonne Limpens, Managing Human Factors Specialist at Emergo by UL While the time to market for generic inhalers is much shorter compared to novel inhalers because there is no requirement for generic product manufacturers to repeat clinical research on ingredients or dosage forms already approved for safety and effectiveness, one aspect often overlooked during … [Read more...] about Human Factors (HF) Considerations for Generic Inhalers Using Off-the-shelf Devices
Roivant’s Pulmovant subsidiary developing mosliciguat DPI licensed from Bayer for the treatment of PH-ILD
Roivant has revealed that its Pulmovant subsidiary is developing inhaled dry powder mosliciguat for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD), and Pulmovant presented a poster with data from the Phase 1b ATMOS study of mosliciguat at the 2024 ERS Congress. Roivant says that it paid approximately $14 million up front … [Read more...] about Roivant’s Pulmovant subsidiary developing mosliciguat DPI licensed from Bayer for the treatment of PH-ILD
Silo Pharma says that it completed pre-IND meeting with the FDA regarding SPC-15 intranasal ketamine for PTSD and anxiety
Silo Pharma announced that it has received responses from the FDA following a pre-IND meeting regarding SPC-15 soft mist intranasal ketamine for post-traumatic stress disorder (PTSD) and stress-induced anxiety disorder. Silo is planning to take advantage of the 505(b)(2) pathway for SPC-15, which it has licensed from Columbia University. In November 2023, Silo … [Read more...] about Silo Pharma says that it completed pre-IND meeting with the FDA regarding SPC-15 intranasal ketamine for PTSD and anxiety
Aptar Pharma to offer services for development projects based on Pulmotree’s Kolibri nebulizer platform
Aptar Pharma announced that it has signed a development and promotion agreement with Pulmotree related to Pulmotree's Kolibri mesh nebulizer, which it refers to as a non-propellant liquid inhaler (NPLI) platform. The company says that its subsidiaries, including inhalation CRO Nanopharm and human factors specialist Noble, will support Kolibri development projects for … [Read more...] about Aptar Pharma to offer services for development projects based on Pulmotree’s Kolibri nebulizer platform
AstraZeneca says that it has completed studies to support regulatory submissions for LGWP propellant version of Breztri (Trixeo) Aerosphere MDI
AstraZeneca announced that it now has the data to support regulatory submissions for a new formulation of of Breztri (Trixeo) Aerosphere budesonide / glycopyrronium / formoterol using Honeywell's Solstice Air HFO 1234ze(e), a low global warming potential (LGWP) propellant. The company says that it now plans to initiate submissions for the reformulated MDI by the end … [Read more...] about AstraZeneca says that it has completed studies to support regulatory submissions for LGWP propellant version of Breztri (Trixeo) Aerosphere MDI
ARS Pharmaceuticals submits sNDA for Neffy 1 mg epinephrine nasal spray for anaphylaxis in small children
ARS Pharmaceuticals announced that it has submitted a supplemental NDA for Neffy 1 mg epinephrine nasal spray for the treatment of anaphylaxis in children weighing 15 to 30 kg (33-66 lbs). The FDA recently approved a 2 mg dose of Neffy for the treatment of anaphylaxis in patients weighing 30 kg or more. At that time, the company said that it intended to submit the … [Read more...] about ARS Pharmaceuticals submits sNDA for Neffy 1 mg epinephrine nasal spray for anaphylaxis in small children
Ji Xing’s Chinese Phase 3 trial of Milestone’s etripamil nasal spray meets primary endpoint
According to Milestone Pharmaceuticals, a Phase 3 trial of etripamil nasal spray in patients with paroxysmal supraventricular tachycardia (PSVT) that was conducted by Ji Xing Pharmaceuticals in China met its primary endpoint of the proportion of patients converting to sinus rhythm within 30 minutes post-dose. Ji Xing acquired the Chinese rights to etripamil for PVST … [Read more...] about Ji Xing’s Chinese Phase 3 trial of Milestone’s etripamil nasal spray meets primary endpoint
ENA Respiratory gets additional funding from the US Department of Defense for development of INNA-051 intranasal antiviral
ENA Respiratory announced that it has received a contract extension from the US Department of Defense (DoD), providing additional funds for continued development of INNA-051, a dry powder intranasal TLR2/6 agonist. In January 2023, ENA Respiratory announced that the DoD had provided funding to develop a dry powder formulation of the antiviral, which had previously … [Read more...] about ENA Respiratory gets additional funding from the US Department of Defense for development of INNA-051 intranasal antiviral