The U.S. FTC’s antitrust challenge to Amgen Inc.’s $27.8 billion acquisition of Horizon Therapeutics plc has been resolved. Amgen agreed to do what it said it would do all along: not bundle pharmacy benefit manager rebates on high volume blockbuster drugs Tepezza and Krystexxa. Read More
Roche Holding AG’s Genentech subsidiary has broken new ground with a victory in phase III testing of the oral, anaplastic lymphoma kinase (ALK) inhibitor Alecensa (alectinib) in early stage, ALK-positive non-small-cell lung cancer (NSCLC). The drug, well known to doctors in the advanced setting, was compared with platinum-based chemotherapy and met its primary endpoint of disease-free survival at a prespecified interim analysis. Read More
Rapidly evolving artificial intelligence (AI) is effectively resetting all biopharmaceutical companies to the figurative starting line, and collaboration is a key strategy to winning the drug discovery race, an AI-based startup founder said at the Global Bio Conference (GBC) 2023. Read More
Genexine Co. Ltd.’s recombinant human growth hormone eftansomatropin alfa (GX-H9/TJ-101) met the primary endpoint in a phase III pediatric study conducted in China in children with growth hormone deficiency, and the company plans to file a BLA in 2024 in China on the data. Read More
For many multiple sclerosis patients, the approval over the past 30 years of a lengthy list of immunomodulatory therapies has helped to reduce the frequency of relapses and to slow disease progression. However, there has been little parallel progress in the development of remyelination therapies, to tackle the other key pathophysiological dimension of the disease. Patients still have no therapies that can help to repair at least some of the damage that results from flare-ups, and the resulting neuronal loss contributes to further disease progression and disability. Rewind Therapeutics NV, of Leuven, Belgium, is one of a small clutch of firms attempting to tackle this problem. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: ADC, Alpine Immune, Benevolentai, Foghorn, Genexine, Isa, Ischemix, Medincell, Sirnaomics, Theratechnologies. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adagene, ADC Therapeutics, Briacell, Briapro, Coya, Neximmune, Recce. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alcresta, Astrazeneca, Biontech, Daiichi Sankyo, Mallinckrodt, Pfizer. Read More
