And another firm has reached a most-favored nation (MFN) pricing deal with the White House. Johnson & Johnson announced Jan. 8 a voluntary agreement with the Trump administration aimed at improving access and lowering prices for medications in the U.S., in exchange for exempting the pharma firm’s products from tariffs.
Newco Tecregen AG has raised CHF10 million (US$12.5 million) to advance a novel way of regenerating the thymus in order to boost T-cell production and stimulate recovery of the immune system following stem cell transplants and chemo- and radiotherapy.
Ollin Biosciences Inc. is gearing up for global phase III trials this year after disclosing favorable top-line results from its randomized, head-to-head phase Ib Jade study comparing OLN-324, a next-generation VEGF/Ang2 bispecific antibody, to Vabysmo (faricimab, Roche AG), which takes aim at the same targets. The drugs were tested in more than 160 patients with diabetic macular edema (DME) or wet age-related macular degeneration (AMD).
Radiopharma-focused Aktis Oncology Inc. priced its recently upsized IPO, selling 17.65 million shares at $18 apiece, the high end of its pricing range, raising gross proceeds of $318 million, a hopeful sign that 2026 might signal an opening of the IPO window for biopharma.
The concept of the 3 Rs – reducing, refining and replacing animal research – has been championed since the 1950s, when William Russel and Rex Burch argued in their book “The Principles of Humane Experimental Technique” that the 3 Rs could simultaneously improve the treatment of research animals and advance the quality of scientific and medical research and testing. Current standard practices of animal research undeniably cause animal suffering at the same time that they have prioritized replicability over translatability.
Just a few weeks after reporting positive data with izicopan (INF-904) in hidradenitis suppurativa and chronic spontaneous urticaria, Inflarx NV is putting most of its chips on the oral complement C5a receptor inhibitor going forward.
The U.S. FDA signaled during a Type B meeting that existing data could support a BLA filing for Moonlake Immunotherapeutics AG’s sonelokimab to treat the skin disease hidradenitis suppurativa (HS), despite one of two pivotal phase III trials missing the mark.
Debate over Vanda Pharmaceuticals Inc.’s Hetlioz (tasimelteon) for use in jet lag disorder looks to continue after the U.S. FDA rejected the latest supplemental NDA submission, with the agency’s Center for Drug Evaluation and Research concluding the application cannot be approved in its current form.
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Akeso, Arrowhead, Curadel, GSK, Vivavision.
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