US FDA grants breakthrough therapy designation for Lilly’s abemaciclib
The designation is based on data from the breast cancer cohort expansion of the company’s Phase I trial, which studied the efficacy and safety of abemaciclib, a cyclin-dependent
Amberstone Biosciences has signed a partnership and licence agreement with Shanghai Henlius Biotech for conditionally activated T-cell engager candidates to treat solid tumours.
Under the deal, Lonza will develop a scalable manufacturing process for Benitec’s ddRNAi-based and Adeno-Associated Virus (AAV)-delivered products specified for therapeutic use in humans. Lonza will use its
The primary efficacy endpoint is the summed pain intensity difference (SPID) over 1-hour (SPID1). Safety endpoints, such as adverse events and vital signs will also be assessed, as