The FDA's Pulmonary-Allergy Drug Advisory Committee (PADAC) voted at its May 11, 2023 meeting in support of approval of ARS Pharmaceuticals' Neffy intranasal epinephrine for the treatment of allergic reactions, including anaphylaxis, the company announced. Committee members voted 16-6 that the data supported a favorable risk/benefit assessment for use in adults and … [Read more...] about PADAC votes in favor of approval of ARS Pharmaceuticals’ Neffy intranasal epinephrine
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SoftOx Solutions outsources development of SIS inhalation solution to the University of Copenhagen
SoftOx Solutions has announced a restructuring plan that includes shutting down its own GMP facility, laying off employees, and outsourcing further development of its SoftOx inhalation solution (SIS) to the University of Copenhagen. The company said that it would retain ownership of the IP and the commercial rights. In May 2022, SoftOx announced Phase 1 results … [Read more...] about SoftOx Solutions outsources development of SIS inhalation solution to the University of Copenhagen
Lumen Bioscience to develop antiviral intranasal powder for US Department of Defense
Lumen Bioscience said that it has received a contract worth $8.8 million from the Defense Innovation Unit (DIU) of the US Department of Defense for development of "a prototype broad-spectrum, fast-acting intranasal powder for treatment and prevention of known and emerging viral respiratory infections." The funding is part of "Project Panacea," run by DIU and the Joint … [Read more...] about Lumen Bioscience to develop antiviral intranasal powder for US Department of Defense
Codagenix initiates pediatric Phase 1 trial of CodaVax-RSV intranasal vaccine for the prevention of RSV
Codagenix announced that it has initiated a Phase 1 study of its CodaVax-RSV live-attenuated intranasal vaccine candidate in children aged 6 months to 5 years, with the study expected to enroll 18 children aged 2 to 5 years and 33 children aged less than 2 years. The FDA cleared an IND for the study in mid-2022. A previous Phase 1 study evaluated the nasal spray in … [Read more...] about Codagenix initiates pediatric Phase 1 trial of CodaVax-RSV intranasal vaccine for the prevention of RSV
Nanoform announces completion of successful GMP inspection
Nanoparticle technology specialist Nanoform Finland has announced the completion of a successful GMP inspection of its API manufacturing facility by the Finnish Medicines Agency (FIMEA). The company said that the agency issued no critical or major observations following the March 28, 2023 inspection, and the company's license was renewed. An independent GMP auditor … [Read more...] about Nanoform announces completion of successful GMP inspection
Chance Pharmaceuticals acquires rights to distribute Inbrija levodopa DPI in China
Hangzhou Chance Pharmaceuticals will pay Acorda Therapeutics $2.5 million up front for distribution rights to Inbrija levodopa DPI in China plus another $6 million in "a near term milestone payment" as well as $3 million on approval and as much as $132.5 million in sales milestones. Chance will also pay by the carton for Acorda to supply Inbrija to the company. Acorda … [Read more...] about Chance Pharmaceuticals acquires rights to distribute Inbrija levodopa DPI in China
FDA accepts Optinose’s sNDA for Xhance, sets PDUFA date
According to Optinose, the FDA has accepted the company's sNDA to expand the use of Xhance fluticasone propionate nasal spray for the treatment of chronic sinusitis in patients without nasal polyps and has set the PDUFA target date for completion of its review as December 16, 2023. The FDA approved Xhance for the treatment of nasal polyps in 2017. Optinose submitted … [Read more...] about FDA accepts Optinose’s sNDA for Xhance, sets PDUFA date
Following the sudden death of CEO Lisa Yañez, Anne Whitaker will lead Aerami
Aerami Therapeutics has issued a statement following the death of CEO Lisa Yañez, who was killed in a car accident on May 2, 2023 in Chapel Hill, NC, USA, offering condolences to Yañez's family and announcing that former CEO and current Executive Chairwoman Anne Whitaker will assume leadership of the company. Yañez joined Aerami in June 2022 as Chief Operating … [Read more...] about Following the sudden death of CEO Lisa Yañez, Anne Whitaker will lead Aerami
Strides and Orbicular partner on development of nasal sprays
Generics manufacturer Strides Pharma Science and CRO Orbicular Pharmaceutical Technologies, both based in India, have announced a new strategic partnership where Orbicular will formulate 4 nasal sprays to be manufactured and commercialized by Strides. According to the announcement, Strides will manufacture the nasal sprays at its facility in Chestnut Ridge, NY, USA … [Read more...] about Strides and Orbicular partner on development of nasal sprays
Bausch Health launches Ryaltris olopatadine / mometasone furoate nasal spray in Canada
Bausch Health has announced the launch of Ryaltris olopatadine / mometasone furoate nasal spray for in Canada. Bausch Health acquired the Canadian rights to Ryaltris from Glenmark in March 2021, and Health Canada approved the nasal spray for the treatment of moderate to severe seasonal allergic rhinitis in September 2022. Ryaltris was approved by the FDA in … [Read more...] about Bausch Health launches Ryaltris olopatadine / mometasone furoate nasal spray in Canada