Impressive data from an interim readout of Bridgebio Pharma Inc.’s BBP-418 in limb-girdle muscular dystrophy type 2I/R9 has the company prepping to meet with the U.S. FDA to discuss plans for the upcoming NDA filing, including the possibility for seeking full approval for what could be the first therapy for the rare muscular disease.
The $12.5 billion acquisition of Avidity Biosciences Inc. by Novartis AG strengthens the company’s neuroscience pipeline and marks the second biggest deal that’s been announced this year. It also is the fifth M&A deal in the past five weeks to top the $1 billion mark, a sign that the market may be strengthening.
During the first poster session of the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, held in Boston, several presentations highlighted novel strategies that move beyond traditional antibody-drug conjugate payloads and targets.
At this year’s AACR-NCI-EORTC conference, several presentations brought to light new ways to tackle the treatment of genomically unstable cancers. Genomically unstable cancers can be treated by exploiting their repair dependencies, inducing catastrophic DNA damage, or harnessing immune responses to instability.
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Annji, Apotex, Biocon, Halia, Heidelberg, Merck, Myosin, Sanofi.