Flagship Pioneering Inc., the serial biotech-founding investor that created RNA trailblazer Moderna Inc., is putting its money behind Senda Biosciences Inc. and a technology that aims create medicines by changing the way the body interacts with organisms such as plants and microbes. Senda has just announced the closing of a $98 million series B funding round, after completing a $55 million extension that brings total funding raised so far to $143 million. Read More
Bright Peak Therapeutics Inc. closed a $107 million series B round to progress a pipeline of engineered cytokines, which are produced using a chemical synthesis method instead of classical recombinant protein production approaches. Read More
DUBLIN – Verona Pharma plc is adding $25 million cash to its balance sheet, as well as $15 million worth of stock in Nuance Biotech Co. Ltd., and could earn up to $179 million more in milestones linked to the development in the greater China region of ensifentrine, its candidate maintenance therapy for chronic obstructive pulmonary disorder (COPD). Read More
Bristol-Myers Squibb Co. has released top-line phase III results from its CAR T therapy Breyanzi (lisocabtagene maraleucel) that could support its use earlier in patients with refractory large B-cell lymphoma, outperforming standard stem cell transplant therapy. Read More
At the 2021 virtual annual meeting of the American Society for Clinical Oncology (ASCO), results of the VISION trial testing the addition of Novartis AG’s radiopharmaceutical Lutetium-177-PSMA-617 (Lutetium-PSMA) to individualized standard-of-care regimens in metastatic castration-resistant prostate cancer improved both overall survival and radiographic progression-free survival. Read More
Of all the controversies surrounding the FDA, the agency’s reliance on user fees and its use of accelerated review of therapies might be the most consistent sources of public angst. Coleen Klasmeier, a partner of Sidley Austin LLP, told BioWorld that while she is not particularly concerned about regulatory capture stemming from FDA reliance on user fees, it may be appropriate to ask whether the drug premarket review process leaves FDA staff with more confidence in a new drug application than the data would seem to suggest. Read More
The good of the many versus the good of the individual is the age-old question that faced the FDA’s Vaccines and Related Products Advisory Committee (VRPAC) June 10 as it considered the risk-benefit issues of COVID-19 vaccines in children. Panelist Cody Meissner, director of pediatric infectious disease at Tufts Medical Center, said while he believes a vaccine is needed for children, he wants to know that the safety of the vaccine is greater than the risk of hospitalization for people younger than 18. Read More
Suzhou Zelgen Biopharmaceuticals Co. Ltd. won approval from China’s NMPA for Zepsun (donafenib tosylate) to treat patients with unresectable hepatocellular carcinoma who have not received systemic treatment. The small-molecule drug, independently developed by Zelgen, is a multitarget kinase inhibitor. Read More
New hires and promotions in the biopharma industry, including: Advanced Proteome, Arcutis, Cyxone, Flexion, Ibio, Medexus, Monte Rosa, Ocugen, Palleon, Skye. Read More
New and updated preclinical and clinical data presented by biopharma firms at the American Society of Clinical Oncology's annual meeting, including: Antengene. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Biotheryx, Inozyme, Lipac, Novalgen, Omeros. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adamis, Arena, Coordination, Dynacure, Lyra, Moderna, Ocugen, Scynexis, Vertex. Read More
