CDMO Ritedose Corporation announced that it will manufacture Verona Pharma's Ohtuvayre nebulized ensifentrine, which was approved by the FDA in June 2024 for the treatment of COPD. Also in June 2024, Ritedose announced that it was adding blow-fill-seal (BFS) capacity for an additional 180 million unit doses at its manufacturing facility in Columbia, SC, … [Read more...] about Ritedose to manufacture Verona’s Ohtuvayre inhaled ensifentrine
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Serán Bio gets $200 million investment to support new commercial manufacturing facility
CDMO Serán Bioscience announced "a strategic growth transaction" led by Bain Capital Life Sciences that is worth more than $200 million, with the funds intended to support completion of a new commercial-scale manufacturing facility in Bend, Oregon, where the company is headquartered. According to Serán Bio, the commercial-scale facility, which is expected to be … [Read more...] about Serán Bio gets $200 million investment to support new commercial manufacturing facility
Vectura to be acquired by Phillips Medisize parent Molex
Inhalation CDMO Vectura has been sold to Molex for £150 million up front and up to an additional £148 million in potential payments, the companies have announced. Following the acquisition, Vectura will be operated by Phillips Medisize, which was acquired by Molex in 2016. The sale is expected to close by the end of this year. According to the Vectura Fertin press … [Read more...] about Vectura to be acquired by Phillips Medisize parent Molex
Nuance to market Altamira’s Bentrio bentonite-based nasal spray in additional Asian countries
Altamira Therapeutics has announced an extension of its 2022 license and distribution agreement that gave Nuance Pharma the rights to market Altamira's Bentrio nasal spray in China, Hong Kong, Macau and South Korea. According to Altamira, Nuance has recently submitted a marketing application for Bentrio in China. The revised deal adds Singapore, Malaysia, Thailand, … [Read more...] about Nuance to market Altamira’s Bentrio bentonite-based nasal spray in additional Asian countries
Leyden Labs names Jintanat Ananworanich as new Chief Medical Officer
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
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