Missoula, Montana-based Inimmune Corporation has announced the initiation of Phase 1/1b trial of its INI-2004 intranasal toll-like receptor 4 agonist, which the company is developing for the treatment of allergic rhinitis. According to the company, the Phase 1 SAD portion of the study, which is taking place in Australia, will enroll healthy volunteers and patients … [Read more...] about Inimmune initiates Phase 1/1b trial of INI-2004 intranasal TLR4 agonist
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Viatris and Kindeva launch Breyna budesonide / formoterol fumarate MDI in the US
Viatris and Kindeva Drug Delivery have announced the launch of Breyna budesonide / formoterol fumarate MDI, a generic version of AstraZeneca's Symbicort, for the treatment of asthma in patients aged 6 and over and for the treatment of COPD. The FDA tentatively approved Breyna in March 2021 and issued a final approval in March 2022 amid patent litigation from … [Read more...] about Viatris and Kindeva launch Breyna budesonide / formoterol fumarate MDI in the US
Marinomed’s Carragelose nasal spray gets marketing authorization in Mexico
Marinomed Biotech said that its partner M8 Pharmaceuticals has received marketing authorization for Carragelose iota-carrageenan nasal spray in Mexico. M8 acquired the rights to market the nasal spray in Mexico and Brazil in 2021. According to the announcement, the product will be marketed in Mexico as "Barlo," with a launch "envisaged for the next season." … [Read more...] about Marinomed’s Carragelose nasal spray gets marketing authorization in Mexico
Defender Pharmaceuticals submits NDA for DPI-386 scopolamine nasal gel for the prevention of motion sickness
Defender Pharmaceuticals announced that it has submitted an NDA for its DPI-386 scopolamine nasal gel for the prevention of motion sickness in adults. According to the company's web site, Defender has worked with the US Navy and with the National Aeronautics and Space Administration (NASA) on development of DPI-386. Epiomed Therapeutics, which was founded by … [Read more...] about Defender Pharmaceuticals submits NDA for DPI-386 scopolamine nasal gel for the prevention of motion sickness
FDA approves Harm Reduction’s RiVive naloxone nasal spray
The FDA announced that it has approved Harm Reduction Therapeutic's NDA for RiVive naloxone nasal spray for the reversal of opioid overdose. Harm Reduction initiated a rolling NDA submission for RiVive in October 2022, and the agency accepted the NDA for priority review in December 2022. RiVive is approved for OTC sales; however, Harm Reduction's web site says that … [Read more...] about FDA approves Harm Reduction’s RiVive naloxone nasal spray
Liquidia submits sNDA for Yutrepia treprostinil DPI to add PH-ILD indication
Liquidia Corporation announced that it has submitted an sNDA for its Yutrepia treprostinil DPI, which was tentatively approved by the FDA in November 2021 for the treatment of pulmonary arterial hypertension (PAH). The supplemental application is for the use of Yutrepia to treat pulmonary hypertension associated with interstitial lung disease (PH-ILD). According to … [Read more...] about Liquidia submits sNDA for Yutrepia treprostinil DPI to add PH-ILD indication
Krystal Biotech says that it will develop an inhaled formulation of its KB707 gene therapy for the treatment of solid tumors
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
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