Calls for papers
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The FDA has now fully approved Lupin’s ANDA for its generic version of Sunovion’s Brovana arformoterol tartrate inhalation solution for the treatment of COPD. Brovana was approved by the FDA in 2006. The agency tentatively… Read more . . .
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Celltrion Group announced that it has submitted an IND application for a Phase 3 trial of an inhaled COVID-19 antibody cocktail for the treatment of mild-to-moderate COVID-19. In July 2021, Celltrion announced that it had… Read more . . .
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Aptar Pharma announced that it has launched a metered dose inhaler add-on sensor called HeroTracker Sense. According to Aptar, the device has been CE marked and is “pending FDA approval.” HeroTracker inhaler sensors were originally developed… Read more . . .
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Third Pole Therapeutics announced that it has raised an additional $25 million in a financing round led by existing investors for continued development of its tankless inhaled nitric oxide (iNO) systems. The company also said… Read more . . .
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Biocorp and RxPack have announced a new distribution agreement giving RxPack the exclusive rights to commercialize Biocorp’s Inspair inhaler sensor in Eastern Europe, Southeast Asia, South America, and the Middle East. Lindal had obtained the… Read more . . .
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Ethris GmbH said that it has closed a $26.3 million Series B financing round led by Laureus Capital, with proceeds earmarked for continued development of the company’s ETH47 and ETH42 inhaled mRNA based therapies, which… Read more . . .
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Aridis Pharmaceuticals announced that it has received an award of $1.9 million from the Bill & Melinda Gates Foundation to fund preclinical development of inhaled monoclonal antibodies against influenza and SARS-CoV-2. Aridis is developing both… Read more . . .
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Intranasal vaccine developer Leyden Laboratories has closed a $140M Series B financing led by Casdin Capital and GV, the company said. Proceeds will go toward development of the company’s pipeline, which includes its PanFlu intranasal… Read more . . .
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Opiant gets additional $2.2 million in BARDA funding for development of OPNT003 intranasal nalmefene
According to Opiant Pharmaceuticals, the company’s contract with the Biomedical Advanced Research and Development Authority (BARDA) has been amended to provide an additional $2.2 million to support activities related to a 505(b)(2) NDA submission for OPNT003 nalmefene… Read more . . .
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Aculys Pharma has acquired development and commercialization rights to Neurelis’s Valtoco diazepam nasal spray in Japan, Australia, and other Asia-Pacific countries, including New Zealand, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, South Korea, Thailand and… Read more . . .
Upcoming Events
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December 9-December 11: DDL 2026, Edinburgh, Scotland
April 27-30: RDD Europe 2027, Antibes, France
May 12-13: USP Joint Workshop: Quality and Product Performance Testing of Orally Inhaled and Nasal Drug Products, Rockville, MD, USA
June 30: RespireX 2027, Boston, MA, USA