Novavax Inc. reported an overall efficacy rate of 90.4% in a phase III trial of its COVID-19 protein subunit vaccine, NVX-CoV2373, which it conducted in the U.S. and Mexico. The vaccine provided 100% protection against moderate and severe disease and 100% protection against variants of SARS-CoV-2 deemed not to be of concern or interest. Gaithersburg, Md.-based Novavax is on track to file for approval during the third quarter. By the end of that period, it aims to ramp up production to a monthly run rate of 100 million doses and it aims to scale that to a monthly run rate of 150 million doses by the end of the fourth quarter. Read More
LONDON – The Delta variant of SARS-CoV-2 originally identified in India is causing more serious illness and reducing the effectiveness of vaccines compared to the Alpha (Kent) variant, according to a nationwide study covering Scotland’s whole population of 5.4 million. Read More
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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
The hefty $107.5 million series B financing disclosed June 10 by Synthekine Inc. underscored Wall Street’s interest in engineered cytokines, where an army of companies is developing prospects at varying stages – including Bright Peak Therapeutics Inc., which pulled down a series B in almost exactly the same amount as Synthekine, and on the same day. Read More
The U.S. isn’t the only country tossing COVID-19 vaccines due to potential cross-contamination of the drug substances manufactured at an Emergent Biosolutions Inc. plant. Read More
New hires and promotions in the biopharma industry, including: Amicus, Asher, Athira, Atsena, Aurinia, BIO, Cassava, Editas, Forma, Iosbio, Moderna, Phoremost. Read More
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. Read More
Biopharmas raising money in public or private financings, including: Ambrx, Cel-Sci, Century, Cyteir, Flagship, Hifibio, Inceptor, Isofol, Regencell, Synaptogenix, Verve. Read More
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. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Absci, Aim, Allarity Alzecure, Anavex, Aruvant, Avidea, Biomx, Bristol, Cocrystal, Evgen, Exelixis, Insmed, Montis, Oncoheroes, Quadira, Taiba, Totient, Veraxa. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Gilead, Incyte, Kyowa Kirin, RDIF, Rhovac, Vicore. Read More
