Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adcentrx, Denali, Johnson & Johnson, Omeros, PRM, Urogen.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Apotex, Beigene, Biovaxys, Boehringer Ingelheim, C4, Formosa, Ironwood, Neurocrine, Sona, Viverita, Voyager.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Altesa, Astrazeneca, Beacon, Crispr, Daewon, Daiichi Sankyo, Dr. Falk, Gilead, Ipsen, Marea, Perfuse, Phio, Theriva, Tiumbio, Vertex.
Planting seed money and “wishing” is not enough to claim “irreparable harm” to secure a preliminary injunction or to establish the standing required to appeal a patent board decision, the U.S. Court of Appeals for the Federal Circuit ruled May 7 in two decisions involving Incyte Corp. and Sun Pharmaceutical Industries Ltd.
Ongoing policy issues in the U.S., including the Inflation Reduction Act and recent proposals under President Donald Trump’s administration, have wide ranging implications for the global biopharmaceutical industry, speakers at Bio Korea 2025 said May 8, including a heightened need for all biotechs to draft regulatory strategies.
Following last fall’s $1 billion development deal with Eli Lilly and Co., precision medicine company Haya Therapeutics SA has raised $65 million in a series A. It’s all part of increased validation from big pharmas that long noncoding RNAs, such as those being developed by Haya, have a strong future.
Revolution Medicines Inc. followed the results offered last month with zoldonrasib (RMC-9805), a RAS G12D (ON) inhibitor, with plenty more about pipeline progress – “an embarrassment of riches,” CEO Mark Goldsmith said – during the firm’s first-quarter update. Shares of the firm (NASDAQ:RVMD) closed May 8 at $41.91, up $4.25, or 11%.
Shionogi & Co. said it plans to acquire Japan Tobacco Inc. (JT) subsidiaries Torii Pharmaceutical Co. and Akros Pharma Inc. for ¥160 billion (US$1.1 billion) to expand its global R&D business. The two companies have been negotiating since early 2024, and the deal is structured such that a tender offer will begin on May 8 and end on June 18 with an offer price of ¥6,350 per share to buy at least 11.89% of the minority stake, JT told BioWorld.
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