Despite down-to-the-wire negotiations, the odds are that parts of the U.S. government will shut down at midnight Sept. 30, as Senate Democrats refused to support a seven-week, clean continuing resolution already passed by the House to keep the government funded while Congress hammers out fiscal 2026 spending bills. Read More
Anaptysbio Inc. said it intends to split into two publicly traded companies – one for developing a pipeline, the other for managing royalties – each with its own business model. The royalty company will hold and manage the rights to big-earning Jemperli (dostarlimab) royalties from collaborator GSK plc, along with imsidolimab milestones and royalties from Vanda Pharmaceuticals Inc. Read More
Opus Genetics Inc. will be sitting down with the U.S. FDA to talk about positive three-month data from the pediatric cohort of its ongoing phase I/II trial called OPGx-LCA5-1001 – partially funded by the agency – evaluating OPGx-LCA5, a gene augmentation therapy for ultra-rare Leber congenital amaurosis type 5 (LCA5). The affliction is a severe form of retinal dystrophy that renders babies blind in the first year of life. Read More
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. Read More
Novo Nordisk A/S terminated its global licensing deal with Japan’s Heartseed Inc. for its allogeneic induced pluripotent stem cell (iPSC)-derived cardiomyocytes. Read More
Phase IIb data of Metsera Inc.’s lead GLP-1 receptor agonist, MET-097i, showed significant weight loss and good tolerability, supporting a phase III start later this year, and validating Pfizer Inc.’s decision a week ago to buy the obesity-focused company for $7.3 billion. Read More
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. Read More
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. Read More
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. Read More
