As the U.S. Department of Health and Human Services begins implementing its reorganization and reduction-in-force plan by sending out termination notices this week to 10,000 more employees across its agencies, top Democrats in Congress are demanding details about the plan.
Merck KGaA is exercising its option for a global license to commercialize Abbisko Therapeutics Co. Ltd.’s pimicotinib for $85 million. As previously reported by BioWorld, Abbisko out-licensed China rights to its colony-stimulating factor 1 receptor inhibitor, pimicotinib, to Merck in a deal worth up to $605.5 million in December 2023.
Despite missing the primary endpoint in a phase III study of solriamfetol in major depressive disorder, Axsome Therapeutics Inc. still sees a path to another phase III study. It’s a path some analysts and investors are concerned about, though its precision-medicine approach got plenty of nods of approval.
GRI Bio Inc.’s oral version of tazarotene is showing phase IIa promise in idiopathic pulmonary fibrosis (IPF). The peek at interim safety with the compound, a RAR-βɣ dual agonist designed to inhibit the activity of human type 1 invariant natural killer T cells, consisted of a preplanned analysis of two-week results in the biomarker study. GRI-0621 at 4.5 mg once daily proved safe and well-tolerated in the first 12 patients.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accuredit, Alteogen, BMS, Crinetics, Eli Lilly, Fresenius, Genmab, J&J, Merck, Milestone, Mirum, Sanoti, Shanghai Henlius, Takeda, Valneva.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bioatla, Biontech, Bio-Thera, Curevac, Dr. Reddy’s, Molteni, Oncozenge.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Biontech, Irlab, Johnson & Johnson, Merck, Palatin, Shanton.
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