Rein Therapeutics says that the US Patent and Trademark Office (USPTO) has recently granted US Patents No. 12,280,088 and No. 12,280,089, which cover the dry powder peptide formulation of the company's lead candidate, LTI-03. Both of the new patents are titled "Dry Powder Formulation of Caveolin-1 Peptides and Methods of Use Thereof." Earlier this year, Rein … [Read more...] about Rein Therapeutics gets 2 new US patents covering its LTI-03 DPI
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Kindeva names Melanie Cerullo as Chief Quality Officer
CDMO Kindeva has announced the appointment of Melanie Cerullo as Chief Quality Officer. Cerullo was most recently Chief Quality and Regulatory Officer at Recipharm's ReciBioPharm business unit and previously served in quality roles at Wave Life Sciences, Ameridose, and Amgen. Since the beginning of 2024, Kindeva has expanded its facilities with the acquisition of … [Read more...] about Kindeva names Melanie Cerullo as Chief Quality Officer
Nanopharm announces clinical study to validate SmartTrack platform for demonstration of BE for inhaled drug products
AptarGroup announced that its subsidiary Nanopharm is initiating a clinical study to validate the SmartTrack in-vitro-in-silico modeling platform as an alternative to clinical endpoint studies for determining bioequivalence of inhaled drug products. The study will also collect PK data for validation of Nanopharm's Simhalation physically-based pharmacokinetic (PBPK) … [Read more...] about Nanopharm announces clinical study to validate SmartTrack platform for demonstration of BE for inhaled drug products
FDA approves Neurelis’s Valtoco diazepam nasal spray for use in children aged 2-5
Neurelis announced that the FDA has approved the use of Valtoco diazepam nasal spray for the treatment of seizure clusters in children aged 2 years of age and older. The FDA approved Valtoco for use in patients 6 years old and older in January 2020, and the company initiated a Phase 1/2a trial of Valtoco in epilepsy patients aged 2-5 the next year. According to a … [Read more...] about FDA approves Neurelis’s Valtoco diazepam nasal spray for use in children aged 2-5
Aurobindo says FDA issued Form 483 following inspection of North Carolina inhaler manufacturing facility
Aurobindo has reported to the National Stock Exchange of India that the FDA issued a Form 483 on April 11, 2025, one day after the agency completed an inspection of a manufacturing facility in North Carolina, USA. According to the company, the Form 483, which has not yet been published by the FDA, includes 11 observations that "are procedural in nature." The Raleigh … [Read more...] about Aurobindo says FDA issued Form 483 following inspection of North Carolina inhaler manufacturing facility
AATec Medical raises €4 million for development of ATL-105 inhaled recombinant AAT
German biotech startup AATec Medical announced that it has raised €4 million prior to a series A financing, with the funds going to development of the company's ATL-105 inhaled recombinant alpha-1 antitrypsin (AAT) for the treatment of non-cystic fibrosis bronchiectasis (NCFB). The funding came from the German Federal Agency for Disruptive Innovation (SPRIND) as well … [Read more...] about AATec Medical raises €4 million for development of ATL-105 inhaled recombinant AAT
Orexo announces data from study of intranasal dry powder flu vaccine in rats
According to Orexo, a dry powder formulation of an intranasal influenza vaccine formulated with the company's AmorphOX powder engineering platform has produced a similar immune response in rats compared to a liquid formulation of the same vaccine. The company said that the proof of concept study demonstrated strong mucosal immune response in the nose and in the lung … [Read more...] about Orexo announces data from study of intranasal dry powder flu vaccine in rats
University of Maryland researchers to conduct Phase 2 trial of ENA Respiratory’s INNA-051 dry powder nasal TLR2/6 agonist
ENA Respiratory has announced that researchers at the University of Maryland School of Medicine’s Center for Vaccine Development and Global Health will conduct a Phase 2 study of ENA's INNA-051 intranasal dry powder TLR2/6 agonist, which the company is developing for the treatment of viral respiratory infections. Earlier this year, the company announced that it had … [Read more...] about University of Maryland researchers to conduct Phase 2 trial of ENA Respiratory’s INNA-051 dry powder nasal TLR2/6 agonist
Lonza to develop spray dried formulations of Ethris’s nasal mRNA-based vaccines
Inhaled vaccine developer Ethris and CDMO Lonza have announced that Lonza will develop spray-dried formulations of Ethris mRNA-based vaccine candidates. Earlier this year, Ethris announced that it would receive $5 million from the Coalition for Epidemic Preparedness Innovations (CEPI) for development of spray-dried RNA vaccines for nasal delivery. The companies said … [Read more...] about Lonza to develop spray dried formulations of Ethris’s nasal mRNA-based vaccines
Avalyn announces plans to advance AP02 inhaled nintedanib into Phase 2 trial in IPF patients
According to Avalyn Pharma, Phase 1 trials of AP02 inhaled nintedanib demonstrated that all dose levels of the nebulized formulation were safe and well tolerated and that the company now plans to advance AP02 into a Phase 2 trial in patients with idiopathic pulmonary fibrosis (IPF). Avalyn said that it will present top-line data from the Phase 1 studies at the … [Read more...] about Avalyn announces plans to advance AP02 inhaled nintedanib into Phase 2 trial in IPF patients