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.
French biotech Pep-Therapy SAS is in the midst of raising a €20 million (US$21.62 million) round and, at the same time, prospecting for potential partners after winning FDA orphan drug designation for its bifunctional peptide Pep-010 in the treatment of pancreatic cancer. Pep-010 currently is moving to the conclusion of a phase Ib trial and the new money will fund phase II development.
Otsuka Pharmaceutical Development & Commercialization Inc. filed its BLA with the U.S. FDA for sibeprenlimab to treat immunoglobulin A nephropathy (IgAN). The company’s first BLA, sibeprenlimab is a monoclonal antibody (MAb) that selectively inhibits the activity of APRIL (A PRoliferation-Inducing Ligand) in adults with IgAN.
After announcing that lead candidate sozinibercept (OPT-302) failed the phase III Coast trial in wet age-related macular degeneration (AMD), Opthea has now decided to close the Coast trial as well as the Shore trial. As reported by BioWorld, Opthea announced last week that it was considering its options after lead candidate sozinibercept (OPT-302) failed the phase III Coast trial in wet AMD.
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