Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Incyclix, J&J, Q32, Roche.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Addex, Altamira, Cellectar, Entrada, Er-Kim, Henlius, Ono, Puma, Sandoz, Sinntaxis, Vesicor.
Following a complete response letter last year, Satsuma Pharmaceuticals Inc. received U.S. FDA approval of dihydroergotamine nasal powder to treat acute migraine with or without aura. Branded Atzumi, it is the first product that uses Satsuma’s SMART (Simple MucoAdhesive Release Technology) platform that combines an advanced powder and device technology aimed at making delivery more simple.
Clinical results offered at the recent meeting of the American Urological Association in Las Vegas signal that better treatments may lie ahead for non-muscle invasive bladder cancer.
Dimerix Ltd. sealed an exclusive license agreement with Amicus Therapeutics Inc. for commercialization of its phase III kidney disease candidate, DMX-200, in a deal valued at AU$940 million (US$601.22 million).
“We are prepared for every scenario, even though we don’t know what some of those are.” That sums up the message from executives of Astrazeneca plc, GSK plc and Sanofi SA, when quizzed during presentations of their first-quarter 2025 results this week, about the fallout if pharmaceuticals they import to the U.S. are subject to tariffs.
Less than a week after announcing it had a new CEO, privately held Creyon Bio Inc. began a licensing and research partnership with Eli Lilly and Co. Creyon is getting $13 million up front and could bring in more than $1 billion in milestone payments. The two plan to find, develop and commercialize RNA-targeted oligonucleotide treatments for a range of diseases.
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