Bausch Health has acquired the rights to commercialize Glenmark’s Ryaltris olopatadine / mometasone furoate nasal spray in Canada, Glenmark has announced. According to Glenmark, which is responsible for regulatory approval under the agreement with Bausch, Health Canada is currently reviewing the company's marketing application for Ryaltris for the treatment of … [Read more...] about Bausch Health gets Canadian rights to Glenmark’s Ryaltris nasal spray
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Insmed’s Arikayce inhalation suspension approved in Japan for the treatment of NTM lung disease caused by MAC
The Japanese Ministry of Health, Labour and Welfare has approved Insmed's Arikayce amikacin liposome inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) in patients who have not been successfully treated with a multi-drug regimen, and the company says that it expects to launch Arikayce … [Read more...] about Insmed’s Arikayce inhalation suspension approved in Japan for the treatment of NTM lung disease caused by MAC
Summit Biosciences to produce multidose nasal spray version of Altimmune’s AdCOVID vaccine
Altimmune announced that it has signed a manufacturing agreement with Summit Biosciences for a multidose version of Altimmune's AdCOVID intranasal vaccine against COVID-19. The announcement comes shortly after Altimmune announced an agreement with Lonza for manufacturing of the single dose version of the vaccine in a dedicated suite at Lonza's Texas facility. A Phase … [Read more...] about Summit Biosciences to produce multidose nasal spray version of Altimmune’s AdCOVID vaccine
Copley launches Inhalytix cascade impactor software
Copley Scientific has launched a new software package for cascade impactor management and data analysis called "Inhalytix," which succeeds the company's long-established CITDAS cascade impactor software. The new software, which is 21 CFR Part 11 compliant, can be used with a variety of cascade impactors, including the NGI, the Andersen impactor, and the Fast Screening … [Read more...] about Copley launches Inhalytix cascade impactor software
Sandoz acquires rights to Proventil HFA MDI and authorized generic
Sandoz said that the company has acquired distribution rights to the brand and to an authorized generic of Proventil HFA albuterol MDI from Kindeva Drug Delivery and has already launched the generic MDI in the US. Proventil HFA was first marketed in the US by Schering and then by Merck. In April 2019, Par Pharmaceuticals announced that it had launched an … [Read more...] about Sandoz acquires rights to Proventil HFA MDI and authorized generic
Chiesi launches Bronchitol mannitol DPI in the US
Chiesi USA has announced the US launch of Bronchitol dry powder mannitol for the treatment of cystic fibrosis in adult patients. The FDA approved the Bronchitol DPI in November 2020. The company also announced the publication of data from its Phase 3 trial of Bronchitol in the Journal of Cystic Fibrosis. Chiesi also distributes the DPI, which was developed by … [Read more...] about Chiesi launches Bronchitol mannitol DPI in the US
Phase 2b study of Galecto’s galectin-3 DPI for IPF to discontinue higher dose arm
Galecto has announced that the company's Phase 2b GALACTIC-1 study of GB0139 (formerly TD139) galectin-3 inhibitor DPI for the treatment of idiopathic pulmonary fibrosis (IPF) will discontinue the higher dose (10 mg) arm and will limit enrollment in the lower dose (3 mg) arm to patients who are not taking nintedanib or pirfenidone. The company said that it is making … [Read more...] about Phase 2b study of Galecto’s galectin-3 DPI for IPF to discontinue higher dose arm
FDA clears Meissa’s IND for a Phase 1 study of its intranasal vaccine against COVID-19
Meissa Vaccines announced that the FDA has cleared the company's IND for a Phase 1 clinical study of its MV-014-212 intranasal live attenuated vaccine candidate against SARS-CoV-2. The company announced that it had held a pre-IND meeting with the agency regarding an intranasal vaccine against SARS-CoV-2 in June 2020. The Phase 1 study is expected to enroll 130 healthy … [Read more...] about FDA clears Meissa’s IND for a Phase 1 study of its intranasal vaccine against COVID-19
Positive Phase 1 results for inhaled Ampion for COVID-19
Ampio Pharmaceuticals said that preliminary results from its AP-014 Phase 1 clinical trial of inhaled Ampion for the treatment of COVID-19 demonstrate a significant reduction in all-cause mortality and shorter hospital stays for patients receiving Ampion compared to standard of care alone. Ampio initiated the Phase 1 trial in October 2020. Based on the initial … [Read more...] about Positive Phase 1 results for inhaled Ampion for COVID-19
Lonza to dedicate manufacturing suite to Altimmune’s AdCOVID intranasal vaccine
In an expansion of a manufacturing agreement between Altimmune and Lonza that was announced in November 2020, Lonza has agreed to dedicate a manufacturing suite at its Texas facility for production of Altimmune's AdCOVID intranasal vaccine. The FDA cleared Altimmune's IND for a Phase 1 trial of AdCOVID in February 2021. According to Altimmune, AdCOVID a single dose … [Read more...] about Lonza to dedicate manufacturing suite to Altimmune’s AdCOVID intranasal vaccine