Patients with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment now have a new oral treatment option, with the U.S. FDA’s approval of Novartis AG’s Rhapsido (remibrutinib), a Bruton’s tyrosine kinase inhibitor administered by pill twice daily.
Pfizer Inc. has become the first drugmaker to agree to provide its products at most-favored nation (MFN) pricing, an effort aimed at lowering the costs of U.S. drug prices by bringing them in line with the prices paid in other developed nations.
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Applied, Bioarctic, Dyne, Eisai, Johnson & Johnson, Kedrion, Novo Nordisk, Nrx, Outlook.
Biopharma happenings, including deals and partnerships, and other news in brief: Amgen, Biolinerx, Dogwood, Gilead, GSK, Hanmi, Health Hope, Hemispherian, IO, Kala, Lupin, Nanomi, Precision Medicines, Recode, Serpin, Visufarma.
Novo Nordisk A/S terminated its global licensing deal with Japan’s Heartseed Inc. for its allogeneic induced pluripotent stem cell (iPSC)-derived cardiomyocytes.
Hanmi Pharmaceutical Co. Ltd. and Health Hope Pharma Ltd. may be getting a second wind for encequidar and the Orascovery platform, with Gilead Sciences Inc. picking up exclusive global rights to develop and commercialize encequidar in the field of virology for $2.5 million up front.
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