Insilico Medicine, which claims to be "a generative artificial intelligence (AI)-driven clinical-stage drug discovery company," said that it is "the first AI drug discovery company to venture into nebulized formulations" as the company plans to file an IND for its ISM001-055 inhalation solution for the treatment of idiopathic pulmonary fibrosis. According to the … [Read more...] about Insilico Medicine says it intends to file IND for ISM001-055 inhalation solution for IPF
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Lupin launches Luforbec beclometasone / formoterol MDI in Germany
Lupin announced that its German subsidiary Hormosan Pharma has launched Luforbec beclometasone / formoterol MDI for the treatment of asthma and COPD in Germany. According to Lupin, the price of the MDI, which is a generic of Chiesi's Foster (Fostair), will be set at just over half the reference price. Luforbec has been available in the UK since 2021. Hormosan … [Read more...] about Lupin launches Luforbec beclometasone / formoterol MDI in Germany
Pharma Nordic gets rights to market Altamira’s Bentrio nasal spray in Norway
Altamira Therapeutics announced that Pharma Nordic will market and distribute Bentrio bentonite-based OTC nasal spray for protection against allergens in Norway as part of a deal that could potentially expand to include Sweden, Finland, and Denmark, "subject to meeting certain milestones." Pharma Nordic will begin selling Bentrio in Norway in 2024, the company … [Read more...] about Pharma Nordic gets rights to market Altamira’s Bentrio nasal spray in Norway
FDA approves OTC switch for Padagis’s generic of Narcan naloxone nasal spray
The FDA has approved Padagis's supplemental application for over-the-counter sales of the company's generic version of Narcan naloxone nasal spray, 4 mg, for the reversal of opioid overdose. Padagis initially launched its generic in the US in June 2022. In February 2023, an FDA advisory committee in favor of over-the-counter use of Narcan, and the agency approved … [Read more...] about FDA approves OTC switch for Padagis’s generic of Narcan naloxone nasal spray
Zambon says COVID-disrupted Phase 3 PROMIS-II trial of its CMS I-neb nebulized dry powder colistimethate sodium for NCFB failed to meet its primary endpoint
Zambon said that the Phase 3 PROMIS-II trial of its CMS I-neb inhaled dry powder colistimethate sodium for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult patients with chronic P. aeruginosa lung infections failed to meet its primary endpoint due to disruptions caused by the COVID-19 pandemic; those disruptions also resulted in the early … [Read more...] about Zambon says COVID-disrupted Phase 3 PROMIS-II trial of its CMS I-neb nebulized dry powder colistimethate sodium for NCFB failed to meet its primary endpoint
Advent gets $3 million grant for development of inhaled vitamin A palmitate for the prevention of BPD in newborns
Advent Therapeutics announced that the company has received a $3 million Small Business Innovation Research (SBIR) Phase 2B grant from the National Institutes of Health for continued development of the company's inhaled vitamin A (retinol) palmitate formulation for the prevention of bronchopulmonary dysplasia (BPD) in newborn infants. According to the company, the … [Read more...] about Advent gets $3 million grant for development of inhaled vitamin A palmitate for the prevention of BPD in newborns
Tonix announces initiation of Phase 2 trial of TNX-1900 intranasal potentiated oxytocin for social anxiety disorder
Tonix Pharmaceuticals announced that researchers at the University of Washington have initiated a placebo-controlled Phase 2 trial of Tonix's TNX-1900 potentiated intranasal oxytocin for social anxiety disorder (SAD). The company said that the study is expected to enroll 50 subjects with diagnosed SAD and 50 matched healthy subjects. Researchers will evaluate how a … [Read more...] about Tonix announces initiation of Phase 2 trial of TNX-1900 intranasal potentiated oxytocin for social anxiety disorder
Q&A with Intertek’s Chris Vernall on in-vitro only BE and the new nasal bioequivalence guidances
Intertek Pharmaceutical Services Commercial Director Chris Vernall on how the new FDA nasal bioequivalence guidances support an in vitro only bioequivalence pathway and continue wider industry focus on evolving analytical and in silico tools for generic OINDP testing What is the main difference in in-vitro bioequivalence (IVBE) recommendations between the May 2023 … [Read more...] about Q&A with Intertek’s Chris Vernall on in-vitro only BE and the new nasal bioequivalence guidances
Kindeva, H&T Presspart, and Chiesi sign deal for dose counters
H&T Presspart will expand cleanroom facilities and add a new production line to manufacture Kindeva Drug Delivery's dose counters and dose indicators for use in Chiesi MDIs, the companies have announced. According to the announcement, the dose counters will be used in Chiesi's new lower-GWP MDIs. H&T Presspart previously signed a licensing deal with 3M (now … [Read more...] about Kindeva, H&T Presspart, and Chiesi sign deal for dose counters
Tonix initiates Phase 2 trial of TNX-1900 intranasal potentiated oxytocin for the treatment of obesity in pediatric patients
Tonix Pharmaceuticals has announced the initiation of the Phase 2 POWER study of its TNX-1900 potentiated oxytocin nasal spray in subjects aged 12-18 whose body mass index (BMI) is in the 95th percentile or higher for their age and gender. The study, which is taking place at Massachusetts General Hospital, is expected to enroll 75 participants who will use either … [Read more...] about Tonix initiates Phase 2 trial of TNX-1900 intranasal potentiated oxytocin for the treatment of obesity in pediatric patients