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
Business
Appeals court upholds previous rulings in United Therapeutics suit against Liquidia over Yutrepia
The Court of Appeals for the Federal Circuit has upheld rulings by the United States District Court for the District of Delaware in a patent infringement suit filed by United Therapeutics against Liquidia Corporation alleging that Liquidia's Yutrepia treprostinil DPI infringes patents covering Tyvaso inhaled treprostinil. The FDA tentatively approved Liquidia's NDA … [Read more...] about Appeals court upholds previous rulings in United Therapeutics suit against Liquidia over Yutrepia
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
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
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
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
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
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