In a deal worth $2.4 billion in cash, Eli Lilly and Co. agreed to acquire Dice Therapeutics Inc., gaining a franchise of oral IL-17 inhibitors for chronic autoimmune diseases. Read More
With its Duchenne muscular dystrophy (DMD) drug, vamorolone, under U.S. FDA review, Santhera Pharmaceutical AG has signed a $231 million-plus-royalties North America commercialization deal with Catalyst Pharmaceuticals Inc. Read More
For the second time in a week, measures of serum neurofilament light chain (NfL) took center stage, this time as Denali Therapeutics Inc. unveiled interim data from the open-label, single-arm phase I/II study testing DNL-310 in children with mucopolysaccharidosis II (MPS II), also known as Hunter syndrome. Read More
Following the death of a patient, the U.S. FDA halted Arcellx Inc.’s phase II pivotal trial of its CAR T-cell therapy for relapsed or refractory multiple myeloma (MM), putting Gilead Sciences Inc., which in December made the risky decision to part with $225 million up front for rights to the immunotherapy, in likely turmoil. Read More
Sirnaomics Ltd. is advancing lead siRNA candidate STP-705 for the treatment of squamous cell carcinoma in situ into late-stage clinical testing after sharing encouraging phase II trial results with the U.S. FDA in an end-of-phase II meeting. The company plans to move forward in 2023 with a single-dose study as a subgroup of subjects in a large phase III study. Positive results will provide the basis for completion of this large registrational phase III trial. Read More
Curocell Inc. is inching closer to realizing Korea’s first domestically developed CAR T therapy, presenting “encouraging” interim phase II trial results for anbalcabtagene-autoleucel at the International Conference on Malignant Lymphoma in Lugano, Switzerland. Read More
Bristol Meyers Squibb Co. (BMS) joined the Inflation Reduction Act (IRA) pile-on June 16, filing a third constitutional challenge to the U.S. Medicare drug price negotiations mandated in the law that was narrowly passed last year on a partisan vote. Read More
Rather than waiting on the courts to sort out the 340B dispute between the U.S. Department of Health and Human Services (HHS) and prescription drug manufacturers, a group of senators is looking for bipartisan legislative solutions that would infuse the drug discount program with more accountability, certainty, oversight and transparency. Read More
New hires and promotions in the biopharma industry, including: Adcendo, Brainstorm, C4, Dianthus, Haya, Jasper, Mendus, Nexcella, Renovorx, Splicebio, Veralox. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Allgenesis, Ascendis, BMS, Bone, Chinook, Eli Lilly, Horizon, Kancera, Mirati, Molecular Targeting, Rhythm, Sensorion, Seres, Telix, Ultimovacs, Vera. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: F2G, Freya, Iaso, Sirnaomics, SK. Read More
