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
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Amneal submits ANDA for generic of ProAir HFA albuterol MDI
Amneal Pharmaceuticals announced that it has submitted ANDAs for three complex generics, including a generic version of Teva's ProAir HFA albuterol sulfate metered dose inhaler. Currently, the only listed therapeutic equivalent for ProAir HFA is Lupin's generic, which was approved by the FDA in 2020. Amneal Co-CEOs Chirag and Chintu Patel commented, "We continue … [Read more...] about Amneal submits ANDA for generic of ProAir HFA albuterol MDI
Lupin’s tiotropium bromide DPI approved in Australia
According to Lupin, the company's generic version of Boehringer Ingelheim's Spiriva Handihaler tiotropium bromide DPI has been approved for the treatment of COPD by Australia's Therapeutic Goods Administration (TGA). Lupin said that it will manufacture the inhalation powder at its plant in Pithampur, India. The company's generic version of Spiriva Handihaler has … [Read more...] about Lupin’s tiotropium bromide DPI approved in Australia
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
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