Immuno-oncology company Imugene Ltd. has acquired a worldwide exclusive license to Precision Biosciences Inc.’s allogeneic CD19 CAR T-cell therapy program in a deal worth more than $227 million. The off-the-shelf CD19 CAR T-cell therapy, azercabtagene zapreleucel (azer-cel), could potentially be the first allogeneic CAR T to be approved, Imugene CEO Leslie Chong told BioWorld.Read More
The U.S. FDA has given its first approval for treating fibrodysplasia ossificans progressiva (FOP), an ultra-rare disease that creates bone formation outside the skeleton that can lead to immobility, life-threatening respiratory problems and a total locking of the jaw. Read More
Venatorx Pharmaceuticals Inc. on Aug. 15 said the U.S. FDA accepted its NDA for an intravenous antibiotic combination, cefepime-taniborbactam, to treat complicated urinary tract infection (cUTI), including acute pyelonephritis. Read More
Delcath Systems Inc. reported that the FDA approved its Hepzato Kit for the treatment of adults with unresectable hepatic-dominant metastatic uveal melanoma (mUM). The FDA nod also triggered a second tranche of financing of approximately $35 million from a private placement in March. Read More
The old Viralytics Ltd. team is back together again in a new company called Immvirx Pty Ltd. that is developing oncolytic viruses to tackle the four most deadly cancers, Immvirx CEO and co-founder Malcolm McColl told BioWorld. Read More
Often when the U.S. FDA’s Office of Prescription Drug Promotion (OPDP) determines that the marketing of a drug crosses the line of misbranding, it hands the sponsor an untitled letter schooling it on how the promotional materials run afoul on safety or efficacy claims. Read More
It’s been 25 years since the U.S. FDA issued a final guidance on informed consent and nine years since it asked for comments on a draft guidance to supersede that 1998 guide. Read More
Guests Karen Carey, BioWorld’s managing editor, and Mike Ward, Clarivate’s global head of Life Sciences and Healthcare Thought Leadership, discuss the deals, financing and M&A landscape for the first half of 2023 and how U.K. biopharmas are faring post Brexit. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Calliditas, Design, Galecto, Perspective, Sandoz, Wugen. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aliada, Alaunos, Briacell, Chiesi, Core, Cytomed, Day One, Diffusion, EIP, Eyenovia, Formosa, Impel, Mediwound, Mimedx, Sprint. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amicus, Arcellx, Avidity, Biocorrx, Biostax, Immpact, Oncusp, Pfizer, Thryv, Tiziana, Venatorx, Wugen. Read More
