Krystal Biotech announced that it will develop injectable and inhaled versions of its KB707 gene therapy for the treatment of malignant solid tumors, including metastatic cancer. The company said that it intends to amend an existing IND to add a clinical trial of the inhaled formulation by the end of the year, with the trial expected to begin by mid-2024. Krystal … [Read more...] about Krystal Biotech says that it will develop an inhaled formulation of its KB707 gene therapy for the treatment of solid tumors
Medical
Insilico Medicine says it intends to file IND for ISM001-055 inhalation solution for IPF
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
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
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
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
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
Pendopharm recalls one lot of Rhinaris Nasal Mist in Canada
Health Canada announced that Pharmascience's Pendopharm division is recalling one lot of Rhinaris Nasal Mist saline nasal spray after "testing showed that the preservative in the product may not be as effective as expected." Specifically, the agency said that testing indicated the potential for P. aeruginosa to grow in the product. The lot affected by the recall is … [Read more...] about Pendopharm recalls one lot of Rhinaris Nasal Mist in Canada
Cipla recalls some albuterol MDIs due to a reported valve leak
Cipla US has announced a voluntary recall of 6 batches of albuterol MDIs after a report of valve leakage in a single inhaler manufactured in November 2021. The company said that no adverse events have been reported and that it is recalling all batches of the metered dose inhalers that used the same lot of valves out of "an abundance of precaution." The recalled … [Read more...] about Cipla recalls some albuterol MDIs due to a reported valve leak
Krystal Biotech initiates Phase 1 study of KB407 inhaled gene therapy for CF
Krystal Biotech has announced the initiation of the Phase 1 CORAL-1/US dose escalation trial of its KB407 inhaled gene therapy for the treatment of cystic fibrosis. The Phase 1 study, which is being conducted at the Cystic Fibrosis Institute of Chicago, is expected to enroll approximately 20 CF patients who will receive either KB407 delivered over 30 minutes on 1 day, … [Read more...] about Krystal Biotech initiates Phase 1 study of KB407 inhaled gene therapy for CF
Phase 2/3 trial of MannKind’s MNKD-101 clofazimine inhalation suspension faces delay
MannKind Corporation has filed a notice with the US Securities and Exchange Commission (SEC) stating that manufacturing of clinical trial supplies for its planned Phase 2/3 study of MNKD-101 clofazimine inhalation suspension in patients with nontuberculous mycobacteria (NTM) lung infections will be delayed up to 6 months due to a fire at the facility that was set to … [Read more...] about Phase 2/3 trial of MannKind’s MNKD-101 clofazimine inhalation suspension faces delay