News
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Insmed announced that the first patient has been dosed in a Phase 3b trial of its Arikayce amikacin liposome inhalation suspension in patients with nontuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC). Arikayce is delivered… Read more . . .
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California-based Arcturus Therapeutics announced that it will develop its ARCT-032 aerosolized CFTR mRNA formulation for the treatment of cystic fibrosis. According to Arcturus, preclinical studies of ARCT-032, which is based on the company’s LUNAR (lipid-enabled… Read more . . .
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United Therapeutics announced that it has agreed to pay $105 million for a rare pediatric disease priority review voucher that the company plans to use to get an 8-month FDA review of an NDA for… Read more . . .
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The FDA has issued a clinical hold on Altimmune’s IND for its AdCOVID intranasal COVID-19 vaccine candidate, the company said. Altimmune submitted the IND to the agency in November 2020. According to the company, the… Read more . . .
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Menarini will pay Glenmark an undisclosed amount up front plus milestone payments for exclusive rights to market Ryaltris olopatadine/mometasone furoate nasal spray in 33 European countries, Ryaltris developer Glenmark has announced. Glenmark will be continue… Read more . . .
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According to Polyphor, the UK’s MHRA has authorized a Phase 1 study of the company’s murepavadin inhalation solution, which the company is developing for the treatment of Pseudomonas aeruginosa lung infections in cystic fibrosis patients.… Read more . . .
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Swedish DPI developer Iconovo announced that Monash University has acquired exclusive global rights for the use of Iconovo’s ICOone single dose DPI for delivery of Monash’s inhaled oxytocin for the prevention of postpartum hemorrhage. The… Read more . . .
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Several months after acquiring the rights to TNX-1900 oxytocin nasal spray for the treatment of migraine headaches from Trigemina, Tonix Pharmaceuticals announced that it has acquired an exclusive license to technology from the University of… Read more . . .
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Catalent will supply development services for an intranasal formulation of Novan’s berdazimer sodium for COVID-19, the companies said. Berdazimer sodium is a nitric oxide-releasing polymer based on Novan’s Nitricil platform, and the company is developing… Read more . . .
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Oyster Point Pharma has announced its submission of a 505(b)(2) NDA for its OC-01 varenicline nasal spray for the treatment of dry eye disease. In May 2020, Oyster Point announced positive results from the the… Read more . . .
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