Johnson & Johnson’s Janssen Cilag Ltd. pharma unit has phase III data from its project combining the oral blood cancer drug Imbruvica (ibrutinib) with its blockbuster rival, Venclexta (venetoclax), in chronic lymphocytic leukemia (CLL), which could give it an edge over competitors in the space.
Rapt Therapeutics Inc. CEO Brian Wong said RPT-193 monotherapy in atopic dermatitis (AD) “looks really promising, but there’s still quite a bit to learn” about the small molecule, designed to inhibit the migration of Th2 cells into inflamed tissues by blocking CCR4. Investors saw enough to push the shares of South San Francisco-based Rapt up 115.5%, or $21.45, to close at $40.02, after trading as high as $41.99 during the day.
Biogen Inc.’s pricing of its newly approved Alzheimer’s drug, Aduhelm (aducanumab), has made it the latest bull’s eye for lawmakers and advocacy groups targeting U.S. drug prices, especially given the controversy surrounding the drug’s approval, which has resulted in the resignation of three of the 11 members of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee.
New phase III data on Celltrion Inc.'s COVID-19 therapy, regdanvimab, showed it reduced the risk of hospitalization or death related to the disease for high-risk patients to 3.1% vs. 11.1% for placebo by day 28 of the study. The treatment also proved beneficial to participants across all risk categories, reducing their risk of hospitalization or death to 2.4% vs. 8% for placebo at the same time point.
Iteos Therapeutics Inc. and Glaxosmithkline plc (GSK) are sharing costs for global development of the anti-TIGIT monoclonal antibody EOS-448 and plan to split the U.S. profits in a deal that brings Iteos an up-front payment of $625 million plus up to $1.45 billion in potential milestone payments.
New and updated preclinical and clinical data presented by biopharma firms at the European Hematology Association 2021 Virtual Congress, including: Celltrion, Crispr, Daiichi Sankyo, Debiopharm, Janssen, Kite, Omeros, TG, Vertex, X4.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Gilead, Incyte, Kyowa Kirin, RDIF, Rhovac, Vicore.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adamis, Astrazeneca, Celltrion, Daiichi, Eyegate, G1, Immvira, Novan, Novavax, Oxthera, Precigen, Roche, Scholar Rock, Terns, Tyme, Vertex, Zynerba.
Biopharmas raising money in public or private financings, including: Ambrx, Cel-Sci, Century, Cyteir, Flagship, Hifibio, Inceptor, Isofol, Regencell, Synaptogenix, Verve.
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