Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alvotech, Exelixis, GSK, Intellia, Kashiv, Kelun, Merck, Neurim, Plus, Sanofi, Theratechnologies, Vast.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aadi, GV20, Ionis, Kaken, Mitsubishi, Sobi, Turn, Vesigen, Whitehawk.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aligos, Calidi, IGC, Leap, Merakris , Merakris, Vaximm, Wave Life Sciences.
Bispecific antibodies have gotten plenty of press in recent years, but less prominent in headlines are bifunctional ones – i.e., those that boast one binding site for an antigen and another site for a non-antibody molecule such as a toxin or drug, taking aim at a single target and bringing a secondary function for extra oomph.
Equillium Inc. is forging ahead with regulatory plans for itolizumab in first-line treatment of patients with acute graft-vs.-host disease (GVHD), despite a phase III disappointment. Shares of the La Jolla, Calif.-based firm (NASDAQ:EQ) closed March 27 at 46 cents, down 29 cents, or 39%, on top-line data from the Equator study testing itolizumab, which is designed to target the CD6-ALCAM signaling pathway.
A survey of members of the Bioindustry Innovation Organization (BIO) has exposed what is at stake for the sector, on both sides of the Atlantic, if proposed tariffs are imposed on pharmaceutical imports to the U.S. "A staggering 94% of biotech firms anticipate surging manufacturing costs if tariffs are placed on imports from the EU,” according to BIO.
Transplanting an animal organ into a human is now a closer reality following the successful xenotransplantation of a genetically modified pig liver into a patient diagnosed with brain death in China. The operation was intended to evaluate organ function over a 10-day period. This is a complex experimental trial that did not involve removing the patient's liver and still requires further study. However, the positive preclinical results suggest this strategy could save the lives of those waiting for a human organ, at least in certain cases.
The U.S. Senate has approved the nominations of two key members of the Trump administration, Marty Makary as FDA commissioner and Jay Bhattacharya as NIH director. While these are two of the most critical appointments for the Trump administration, the Senate still has two other important appointments in queue, including the directors of the Centers for Medicare & Medicaid Services and the CDC.
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