According to a LinkedIn post by generic device maker Merxin, the FDA has indicated that Merxin's MRX004 soft mist inhaler is suitable for an ANDA submission for a generic version of Boehringer Ingelheim's Spiriva Respimat tiotropium bromide SMI. Merxin recently announced that it would sponsor doctoral research at the University of Hertfordshire to support development … [Read more...] about FDA indicates that Merxin’s MRX004 SMI could be used for generics of Spiriva Respimat
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Philip Morris acquires Asprihale developer OtiTopic
Philip Morris International (PMI) has acquired inhaled drug developer OtiTopic, as "part of PMI’s strategic plan to leverage its expertise, scientific know-how, and capabilities in inhalation to grow a pipeline of inhaled therapeutics and respiratory drug delivery Beyond Nicotine," the company said. PMI recently announced a £1 billion offer for inhalation CDMO … [Read more...] about Philip Morris acquires Asprihale developer OtiTopic
Ji Xing acquires Chinese rights to two Oyster Point nasal sprays for dry eye
Ji Xing Pharmaceuticals has acquired Chinese development and commercialization rights to Oyster Point Pharma's OC-01 varenicline nasal spray and OC-02 simpinicline nasal spray for the treatment of dry eye disease in a deal that includes a $17.5 million upfront payment and up to $204.8 million in milestone payments and royalties. Earlier this year, Ji Xing acquired … [Read more...] about Ji Xing acquires Chinese rights to two Oyster Point nasal sprays for dry eye
Positive preclinical results for ReCode Therapeutics’ inhaled mRNA therapy for primary ciliary dyskinesia
According to ReCode Therapeutics, studies of its nebulized lipid nanoparticle DNAI1 mRNA therapy for the treatment of primary ciliary dyskinesia in non-human primates demonstrated that a single dose of the mRNA could be delivered successfully for good distribution in the lungs. Along with the in vivo studies, tests in human and mouse cell models confirmed that DNAI1 … [Read more...] about Positive preclinical results for ReCode Therapeutics’ inhaled mRNA therapy for primary ciliary dyskinesia
Insmed launches Arikayce in Japan, advances TPIP into Phase 2 trials
According to an Insmed update, the company launched recently launched Arikayce amikacin liposome inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) in Japan. The Japanese Ministry of Health, Labour and Welfare approved Arikayce for that indication in March 2021. The company also … [Read more...] about Insmed launches Arikayce in Japan, advances TPIP into Phase 2 trials
Berry Global to build new R&D and manufacturing facility in India
Berry Global has announced that it will construct a new facility in Bangalore, India that will serve as an R&D center and will add manufacturing capacity for devices, including nasal spray pumps and inhalers, to meet demand in South Asia. Berry already has one manufacturing facility in Bangalore. Berry Global Chairman and CEO Tom Salmon commented, "Investing in … [Read more...] about Berry Global to build new R&D and manufacturing facility in India
NRx, MannKind partner on possible Zyesami aviptadil DPI
MannKind and NRx Pharmaceuticals will work together on a possible inhaled dry powder aviptadil based on MannKind's Technosphere particle technology, the companies have announced. MannKind said that it would conduct the feasibility study at its facility in Danbury, CT, USA. TFF Pharmaceuticals had previously announced that it was conducting a feasibility study to … [Read more...] about NRx, MannKind partner on possible Zyesami aviptadil DPI
Relief Therapeutics acquires AdVita Lifescience, gets orphan drug designation for inhaled aviptadil for sarcoidosis
According to Relief Therapeutics, the FDA has granted orphan drug designation for RLF-100 inhaled aviptadil for the treatment of sarcoidosis; RLF-100 is currently in Phase 2 development for that indication. Relief also recently acquired German company AdVita Lifescience, which has been developing inhaled aviptadil for human and veterinary use, with Relief citing the … [Read more...] about Relief Therapeutics acquires AdVita Lifescience, gets orphan drug designation for inhaled aviptadil for sarcoidosis
Sanofi to acquire Translate Bio
Sanofi has agreed to pay approximately $3.2 billion for Translate Bio, which is developing inhaled mRNA therapies for cystic fibrosis, primary ciliary dyskinesia, and pulmonary arterial hypertension in addition to a number of intramuscular mRNA vaccines, including vaccines against COVID-19 and influenza. Sanofi is currently partnered with Translate on the … [Read more...] about Sanofi to acquire Translate Bio
Glenmark acquires rights to market SaNOtize’s nitric oxide nasal spray for COVID-19 in a number of Asian markets
Glenmark Pharmaceuticals has acquired the rights to manufacture and sell SaNOtize's nitric oxide nasal spray (NONS) in India and at least a dozen other markets in Asia for the treatment of COVID-19, the companies have announced. Glenmark expects to be ready to launch the nasal spray as "FabiSpray" in India by the fourth quarter of this year following completion of a … [Read more...] about Glenmark acquires rights to market SaNOtize’s nitric oxide nasal spray for COVID-19 in a number of Asian markets