Sweeping in behind Novavax Inc.’s positive phase III COVID-19 vaccine data is Johnson & Johnson’s single-shot COVID-19 vaccine, which met all the primary endpoints and key secondary endpoints in its phase III study, according to an interim analysis that found it to be 85% effective overall in preventing severe disease.
In light of its ongoing restructuring of priorities, Medigene AG, of Planegg/Martinsried, Germany, is now discontinuing its MDG-1021 development program. The company was planning a phase I study of the T-cell receptor-modified T-cell (TCR-T) therapy that targets the antigen HA-1 in patients with relapsed or persistent blood cancers after allogeneic hematopoietic stem cell transplantation.
The record pace of biopharmas filing for IPOs in the U.S. continues as five more companies filed SEC paperwork, looking for gross proceeds totaling $356 million. In 2020, 106 new offerings were completed and raised $22.5 billion, more than double 2018's record of $10.7 billion.
Regeneron Pharmaceuticals Inc. posted positive initial results from its ongoing phase III study of its monoclonal antibody cocktail, REGEN-COV (casirivimab and imdevimab), used as a passive vaccine, designed to provide immediate short-term passive immunity to prevent COVID-19 in people at high risk of infection due to household exposure to a COVID-19 patient. Eli Lilly and Co. reported upbeat news the same day, as the phase III Blaze-1 trial testing its antibody cocktail met its primary and key secondary endpoints.
Aurinia Pharmaceuticals Inc. got its first drug approval with the FDA’s nod to Lupkynis (voclosporin) for treating active lupus nephritis in adults. It’s the first FDA-approved oral therapy for the indication and the second approval in little more than a month for those patients, following the agency’s Dec. 17 approval of Glaxosmithkline plc’s Benlysta (belimumab), for treating active LN.
Busting a logjam of inadequate data sharing methods and communications between pharmas and health authorities around the world is the impetus behind the creation of nonprofit Accumulus Synergy Inc., whose common, cloud-based platform is designed to make the regulatory process easier for everyone involved. The coalition’s initial membership is a Who’s Who of big pharma: Amgen Inc., Astellas Pharma Inc., Bristol Myers Squibb Co., Glaxosmithkline plc, the Janssen Pharmaceutical Cos. of Johnson & Johnson, Eli Lilly and Co., Pfizer Inc., Roche Holding AG, Sanofi SA and Takeda Pharmaceutical Co. Ltd.
Antibody development for treating COVID-19 continues producing positive results, the latest being from Eli Lilly and Co.’s bamlanivimab (LY-CoV-555), which reduced nursing home residents’ risk of contracting symptomatic COVID-19 by 80%, according to new data from its phase III Blaze-2 study.
The frenetic and record pace of biopharmas filing for IPOs in the U.S. continues as five more companies filed SEC paperwork, looking for gross proceeds totaling $356 million. In 2020, 106 new offerings were completed and raised $22.5 billion, which was more than double the previous record of $10.7 billion set in 2018. The race is on for a new record in 2021.
Sekar Kathiresan is building Verve Therapeutics Inc. around the concept of a one-and-done treatment for cardiovascular disease because only half of patients are disciplined enough to take a statin every day. “That’s a huge issue for durable cholesterol lowering after a heart attack,” Verve’s CEO and co-founder told BioWorld.
Arcus Biosciences Inc., in a presentation on the opening day of the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI), reported a 41% objective response rate across the first four cohorts in its phase I dose-escalation study of AB-680, a small-molecule CD73 inhibitor for treating metastatic pancreatic cancer. The data also showed 88% of patients experienced at least some shrinkage of their lesions.
