Atossa Therapeutics Inc. moved a step closer in its efforts to develop a preventative approach to breast cancer, with top-line data from a phase II study showing (Z)-endoxifen significantly reduced mammographic breast density, while demonstrating a good tolerability profile.
Disc Medicine Inc. found itself after an end-of-phase II meeting with the U.S. FDA in what Wainwright analyst Douglas Tsao called a “best-case scenario” regarding the path forward for bitopertin in erythropoietic protoporphyria (EPP).
For the first time, Australians have access to CSL Inc.’s Vazkepa (icosapent ethyl/Vascepa) for managing cardiovascular disease more than a decade after the drug was first approved in the U.S.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bioarctic, Eli Lilly, Feliqs, Lexicon, Verastem.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Davi Farmaceutica, Formosa, Immpact, Lyell Immunopharma.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Biofrontera, Bristol Myers, Essa, Novo Nordisk, Supernus, UCB, Vaccinex.