News
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SpliSense announced that it has initiated the Phase 2b portion of the SPL84-02 trial of the SPL84 inhaled antisense oligonucleotide in CF patients with the 3849+10kb C→T splicing mutation in the CFTR gene. The Phase… Read more . . .
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California-based SMSbiotech announced that the FDA has cleared its IND for a Phase 1b trial of its inhaled small mobile stem (SMS) cell therapy in patients with COPD and that the company intends to initiate… Read more . . .
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US-based CDMO Ritedose Corporation, which manufactures its own inhalation products in addition to offering contract manufacturing services, has announced the appointment of experienced inhalation business executive Carolyn Berg as VP of Strategic Growth. Berg was most recently… Read more . . .
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According to Aurobindo Pharma, the FDA has issued a final approval of the company’s ANDA for 40 mcg and 80 mcg dose versions of a generic equivalent of Teva’s QVAR beclomethasone HFA MDI for the… Read more . . .
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Drug delivery specialist Zeteo Biomedical has announced the availability of its first device for delivery to the lung, the AriesMR DPI, which the company describes as “a reloadable active dry powder inhaler designed for controlled… Read more . . .
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Agomab Therapeutics has announced that the final part of a Phase 1 study of its AGMB-447 inhaled ALK5 inhibitor, which enrolled patients with idiopathic pulmonary fibrosis, demonstrated “a generally favorable safety and tolerability profile” in… Read more . . .
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The Cystic Fibrosis Foundation has agreed to invest up to $7.3 million in Ride Therapeutics to support identification of potential delivery vehicles for inhaled genetic therapies for CF. According to the CFF, Ride plans to test millions… Read more . . .
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According to Nasus Pharma, the FDA has cleared an IND for a study of Nasus’s NS002 intranasal dry powder epinephrine for the treatment of anaphylaxis. Nasus says that it also plans to initiate a pivotal… Read more . . .
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Aptar Pharma will provide nasal delivery technology for a project led by Massachusetts General Hospital Assistant Professor Alice Stanton to develop a platform designed to improve development of therapies intended for nose-to-brain delivery. The company… Read more . . .
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According to Hikma Pharmaceuticals, regulators in the US, Europe, and the UK have accepted submissions for the company’s epinephrine nasal spray for the treatment of anaphylaxis, and the company has also filed a submission in… Read more . . .
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