Major strides for the company on two fronts – psychedelic therapies and treatment-resistant depression (TRD) – came in the form of Dublin-based GH Research plc’s phase IIb data with GH-001, an inhalable mebufotenin (5-MeO-DMT) activator of serotonin 5-HT2A and 5-HT1A receptors that met not only its primary endpoint but all secondary goals in the TRD experiment. Shares of GH (NASDAQ:GHRS) closed Feb. 3 at $17.99, up $7.39, or 69.7%, on word that the fast-acting, short-duration compound led to a significant reduction from baseline of -15.2 points in Montgomery-Åsberg Depression Rating Scale total score on the eighth day of treatment compared with +0.3 points in the placebo group (a difference of -15.5 points, p<0.0001). Read More
Whether Robert F. Kennedy Jr. (RFK) advances in his quest to become the top health care voice in the Trump administration could come down to one vote – that of Sen. Bill Cassidy. The Louisiana doctor is one of 14 Republican members of the Senate Finance Committee, which is scheduled to vote Feb. 4 on whether to send Kennedy’s nomination as Health and Human Services secretary to the full Senate for confirmation. If all 13 Democrats on the committee vote against it, one no vote from a Republican could stop the process. Read More
Japan’s drug pricing scheme has gotten more complicated, and pharma companies should brace themselves for annual price cuts. Industry has been pushing back against the annual price reductions to no avail, Ray Fujii, managing director of LEK’s San Francisco office told BioWorld. Although 2025 is a mid-year revision in Japan, and not a formal price revision year, the system for considering drug prices has gotten more confusing with a new formula for determining price cuts. Read More
Biopharma deal value continued its upward trend in 2024, reaching $230.53 billion, a 6% increase from $217.69 billion in 2023, setting a new record in BioWorld’s data. Deal volume also grew, with 1,429 agreements across licensing, joint ventures and collaborations, up 3.5% from 1,380 in 2023, though still below the peak activity seen from 2019 to 2022. Read More
Scientists at the University of Pittsburgh have tested a broadly neutralizing antibody that binds the stem of a protein against H5N1 avian influenza, which prevented severe disease in nonhuman primates and was effective for at least 8 weeks. The scientists remark on the potential of the design developed by Astrazeneca plc against a possible outbreak of the influenza A virus. Read More
New hires and promotions in the biopharma industry, including: Avanzanite, Boundless, Constructive, Cosette, Genelux, George Medicines, Sandoz. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Imaginab, Scilex, Sorrento, Telix, Valneva. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Axsome, Bavarian Nordic, BMS, Celltrion, Daiichi Sankyo, Merck, Pfizer, Sanofi, Vertex, Viiv, Zai Lab. Read More
