Beyondspring Pharmaceuticals Inc. said it received a complete response letter from the FDA regarding the NDA for plinabulin, the company’s lead asset. The FDA said results of a phase III registrational trial were strong enough to show benefit but a second trial is needed to satisfy the agency.
GE Healthcare Ltd. is expanding its cancer technology capabilities through new alliances with artificial intelligence (AI) companies and researchers. The company said it is teaming up with U.K.-based Optellum Ltd. to advance lung cancer diagnostics, as well as collaborating with the University of Cambridge to develop an AI application that integrates cancer patient data from multiple sources into a single interface.
Bright Peak Therapeutics Inc. has licensed rights to use Livzon Mabpharm Inc.’s anti-PD-1 candidate, LZM-009, to develop its own PD-1 targeted immunocytokines (PD-1 ICs). Bertolt Kreft, chief scientific officer for Bright Peak, told BioWorld that Livzon’s phase II anti-PD-1 “exhibits a promising initial safety and efficacy profile, making it well-suited to the task.
Fennec Inc. received the complete response letter (CRL) it had expected from the FDA, sidelining U.S. development of Pedmark, a formulation of sodium thiosulfate for preventing ototoxicity associated with cisplatin chemotherapy in pediatric patients older than 1 month to those 18 years of age with localized, non-metastatic, solid tumors.
Ursula Matulonis, a co-principal investigator in the latest study with Immunogen Inc.’s antibody-drug conjugate mirvetuximab soravtansine in stubborn ovarian cancer, said the top-line data are “truly spectacular” and bring “the potential to be transformative for patients.”
The Netherlands-based Synaffix BV has expanded a deal focusing on its antibody-drug conjugate (ADC) linker tech with U.S. cancer biotech Mersana Therapeutics Inc., with the revised contract potentially paying out more than $1 billion. Privately owned Synaffix is hoping to ride a wave of interest in ADC technology, which is finally coming of age more than two decades after the first drug of this type was approved.
RSS
