China’s National Medical Products Administration has given the thumbs up to Akeso Pharmaceuticals Inc.’s ebdarokimab for treating moderate to severe plaque psoriasis in adults. An interleukin (IL)-12/IL-23 dual-targeted monoclonal antibody, ebdarokimab (also known as AK-101) is the company's first class 1 new drug approved for autoimmune diseases.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akeso, BMS, GSK, NS Pharma, Regeneron, Sanofi, Tempest, Valneva, Viatris and Zai Lab.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acelyrin, Aerovate, Alumis, Hikma, Jade, Jorna, Ollin, Ono, Novugen, Velavigo.
Ongoing restructurings in the biopharma sector show common themes of cost-cutting, clinical failures and shifting strategic priorities. Companies are increasingly focusing on high-value pipeline assets, closing or consolidating non-core operations and making difficult workforce reductions to preserve capital. While these adjustments may lead to short-term setbacks, they are crucial for ensuring long-term sustainability.
Tired of waiting for the U.S. Congress to get around to making meaningful reforms to pharmacy benefit manager (PBM) practices, states are beginning to take the matter into their own hands. Arkansas recently became the first state to pass a law stopping PBMs, their affiliates or their parent companies from acting as a "fox guarding the henhouse" by being both a price setter and price taker, as the legislation puts it.
Harvard University has filed a lawsuit claiming the Trump administration’s freezing of its federal funding is unlawful and beyond the government’s authority. Announcing the move, Harvard’s president, Alan Garber, highlighted the impact of freezing $2.2 billion in grants – and the threat to freeze a further $1.1 billion – will have on the university’s biomedical research.
Roche AG has become the latest pharmaceutical company to respond to the Trump administration’s threat to impose tariffs, saying it will invest $50 billion in drug and diagnostics manufacturing in the U.S. over the next five years. That figure matches a similar commitment by its Basel, Switzerland-based neighbor, Novartis AG, which on April 11 said it would be investing almost $50 billion in the U.S., also over the next five years.
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