Just as it is for terminally ill cancer patients, time is of the essence for people in the early stages of Alzheimer’s disease. Thus, the clinical meaningfulness of Eli Lilly and Co.’s donanemab is the time it gives patients before the disease progresses, Reisa Sperling, a neurology professor at Harvard Medical School and director of the Center for Alzheimer’s Research and Treatment at Brigham and Women’s Hospital, told the U.S. FDA’s Peripheral and Central Nervous System Drugs Advisory Committee June 10. Read More
Ipsen SA picked up U.S. FDA accelerated approval for its Genfit SA-licensed elafibranor, making it the first new drug in eight years for treating primary biliary cholangitis, though a potential competitor lurks just around the corner. Read More
Focused on oral therapies for obesity, diabetes and rare diseases, Boston-based Syntis Bio Inc., which raised $15.5 million through seed funding last year, emerged from stealth to advance its synthetic tissue-lining technology and a pipeline of candidates. Read More
Acepodia Inc.’s antibody cell conjugation platform could change the way CAR T-cell therapies are manufactured, clearing the way for an off-the-shelf model to treat numerous cancers that is safer and cheaper than current CAR Ts, Acepodia CEO Sonny Hsiao told BioWorld.
Fresh from the sale of one antibody-drug conjugate (ADC) company, Jack Elands has formed another, raising €30 million (US$32.2 million) in seed funding for Adcytherix SAS. The newco brings together the same cast as Elands’ former company, Emergence Therapeutics, which was sold to Eli Lilly and Co. for an undisclosed sum in a deal that closed in August 2023. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 4D, 4Moving, Actinium, Arcturus, Eli Lilly, Genentech, Longboard, Moderna, Oculis, Pacylex, Prokidney, Sellas, Skye, Surrozen, Tharimmune, Vertex. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Almirall, Astrazeneca, Bioarctic, Eisai, Entos, GC, GSK, Moderna, Novel, Roche, Santhera, Shattuck. Read More
