In a deal worth up to $1.8 billion, Biogen Inc. is buying Human Immunology Biosciences Inc. (Hibio), bolstering its late-stage immune-disease treatment portfolio and diversifying its pipeline. The massive amount comprises $1.15 billion up front and as much as $650 in potential milestone payments. The deal in rare diseases brings Biogen phase III-ready felzartamab, a fully human monoclonal antibody that selectively depletes CD38-positive plasma cells and natural killer cells. Hibio also is developing izastobart, an anti-C5aR1 antibody. Both assets were in-licensed from Morphosys AG in June 2022. Hibio also has mast cell programs in the discovery stage. Read More
In lieu of pending guidance, the U.S. FDA’s approval May 20 of Biocon Biologics Ltd.’s Yesafili and Samsung Bioepis Co. Ltd.’s Opuviz as interchangeable biosimilars to Regeneron Pharmaceuticals Inc.’s Eylea (aflibercept) provides further insight into how the agency is approaching the market exclusivity the Biologics Price Competition and Innovation Act awards to the first approved interchangeable for any given biologic. Read More
Shares of Redwood City, Calif.-based Rezolute Inc., and Korean parent company Handok Inc., rose May 22 on positive results of a phase II proof-of-concept study for its investigative oral diabetic macular edema (DME) drug, RZ-402. RZ-402 is an oral small-molecule plasma kallikrein inhibitor designed to block vascular leakage and inflammation for treating chronic DME. Read More
Hørsholm, Denmark-based Contera Pharma A/S’ lead asset for levodopa-induced dyskinesia in Parkinson’s disease, JM-010, failed to meet its primary endpoint in the late-stage phase IIb Astoria trial. JM-010 is a novel drug formulation and 5-HT receptor modulator that combines existing medications of immediate-release buspirone and extended-release zolmitriptan. Read More
In a paper published in the May 17, 2024, online issue of Cell, investigators from the Duke Human Vaccine Institute reported that a sequence of three immunizations in the HVTN-133 trial was sufficient for the development of heterologous or broadly neutralizing antibodies that protected against several strains of HIV. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aligos, Aslan, Avalyn, Biodexa, Celltrion, Dermavant, Edgewood, Eli Lilly, Faron, Ferring, GSK, Innocare, Insmed, Ironwood, Janssen, Regeneron, Remegen, Telix, Vedanta. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alligator, Biocon, Bioepis, BMS, Cantex, Cingulate, Durect, Eli Lilly, GSK, Innovent, Larimar, Molecure, Ractigen, Roche, SAB, Transposon. Read More
