As expected, the FDA cleared Biocryst Pharmaceuticals Inc.’s oral, once-daily Orladeyo (berotralstat, formerly known as BCX-7353) for the prevention of hereditary angioedema (HAE) attacks. Last month, Biocryst, as part of its earnings report, said approvals of the compound, a kallikrein inhibitor evaluated by U.S. regulators without an advisory committee meeting, could come in Japan this month and in the EU by the first half of next year. Read More
There will be plenty of data from clinical trials testing treatments for various lymphomas at the 62nd American Society of Hematology (ASH) annual meeting this weekend. While CAR T cells have changed the landscape in the relapsed and refractory space for large B-cell lymphoma patients with two FDA approved medications, Kymriah (tisagenlecleucel, Novartis AG) and Yescarta (axicabtagene ciloleucel, Gilead Sciences), "the uptake has been good but not dominant. There's still plenty of space. There's still plenty of need," Jason Westin, leader of the diffuse large B-cell lymphoma research team at the University of Texas MD Anderson Cancer Center in the Department of Lymphoma and Myeloma, said on a call with clients from Raymond James. Read More
New phase III data on Takeda Pharmaceutical Co. Ltd.'s TAK-620 (maribavir) for the treatment of transplant recipients with tough-to-treat cytomegalovirus (CMV) infections met the trial's primary endpoint, setting the company up to file an NDA for the oral antiviral in the first half of next year. Read More
The independent data monitoring committee overseeing Cortexyme Inc.’s phase II/III trial of atuzaginstat (COR-388), a gingipain inhibitor for patients with Alzheimer’s disease, has recommended the study continue to its one-year endpoint. Read More
HONG KONG – Olix Pharmaceuticals Inc. has raised ₩41.5 billion (US$37.90 million) to support the company’s U.S. expansion and advance its pipeline globally. Read More
Preclinical startup Tavotek Biotherapeutics Ltd., with operations in Pennsylvania and Suzhou, China, boasts two technology platforms for discovering and developing molecular-targeted biologics for cancers and autoimmune diseases and is working to push its candidates, including a bispecific antibody, to the clinic next year. Read More
New and updated preclinical and clinical data presented by biopharma firms at the American Society of Hematology’s annual meeting, Dec. 5-8, including: In8bio, Incyte, Jannsen, Rigel. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AB Science, Apeiron, Ascletis, Clover, Cortexyme, Precision, Takeda, Sutro. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Blubird, Greenwich Lifesciences Companies: Entheon, Greenwich, I-Mab, Magenta, Moderna, Pharmaengine, Sentinel, Sherlock, Tevard, Tolo, Wonder, Zogenix. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alligator, Biocryst, Engene, Johnson & Johnson, Novo Nordisk, PTC. Read More
