With a landmark U.K. approval in hand for Casgevy (exagamglogene autotemcel [exa-cel]) to treat sickle cell disease and transfusion-dependent beta thalassemia, Crispr Therapeutics AG and partner Vertex Therapeutics Inc. are turning their attention to the PDUFA dates set by the U.S. FDA for the treatment in both conditions. Read More
More than a week earlier than its PDUFA date, Bristol Myers Squibb Co. received U.S. FDA approval of its next-generation ROS1 tyrosine kinase inhibitor repotrectinib for adults with ROS1-positive locally advanced or metastatic non-small-cell lung cancer. Read More
From the start of the Nov. 16 Oncologic Drugs Advisory Committee meeting, the U.S. FDA made it clear that withdrawing Acrotech Biopharma Inc.’s peripheral T-cell lymphoma drugs, Folotyn (pralatrexate) and Beleodaq (belinostat), from the market until a long-overdue confirmatory trial is completed is not an option given the current treatment landscape. Read More
South Korean pharmaceutical Voronoi Inc. said that New Jersey-based Pyramid Biosciences Inc. terminated its previous $846 million deal for Voronoi’s solid and breast cancer drug candidate, VRN-08, in a letter dated Oct. 24, 2023. Read More
Etcembly emerged from stealth mode in August with something it regards as seemingly impossible: A machine learning platform that has the ability to predict and engineer – at never-seen-before scale and speed – T-cell receptors (TCR) that enable bispecific T-cell engager antibodies targeting cancer cells to be produced. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aribio, Carmot, Chromadex, Compass, Grifols, Inmune, Orionis, Provectus, Rivus, Scisparc, Tonix. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Amgen, Ares, Astellas, Curetis, Femasys, Fractyl, Homology Medicines, Mayne, Octave, Pharmacyte, Postera, Propella, Q32 Bio, Therapeuticsmd, ZZ Biotech. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 60 Degrees, Ascendis, Awakn, Chemomab, Kesin, Saptalis, Scirhom, Sirpant, Solid and Xentria. Read More
