FDA approved a combination of Tibsovo (ivosidenib) and Vidaza (azacitidine) for the treatment of patients with newly diagnosed IDH1-mutant acute myeloid leukemia who are 75 years or older or with comorbidities that prevent the use of induction chemotherapy.
An analysis conducted by Friends of Cancer Research showed that the FDA Breakthrough Therapy Designation criteria select drugs that lead to better outcomes for patients with lung cancer.
A committee of the European Medicines Agency recommended the approval for expanded use of Keytruda (pembrolizumab) as a standalone therapy for the adjuvant treatment of adults and adolescents aged 12 years and older with stage IIB or IIC melanoma who have undergone complete resection.
Case Western Reserve University signed an exclusive license agreement with Picture Health to develop AI technologies to help predict, diagnose, and treat lung cancer.
AmerisourceBergen launched Clinical Trial Navigator, a solution suite that supports biopharmaceutical clinical trial recruitment within community-based specialty practices.
Paige received CE-IVD and UKCA marks for the Paige Prostate Biomarker Suite, an AI software designed to detect the presence of four prostate cancer biomarkers on digitized tissue images stained with hematoxylin and eosin. This is Paige’s first European regulatory certification of image-based biomarker detection on H&E-stained tissue samples.
Cancer Research UK and the Stichting Oncode Institute, an independent research institute in the Netherlands, formed a strategic alliance focused on translating cancer research into benefits for patients.
RaySearch Laboratories AB and GE Healthcare said they are aiming to develop a radiation therapy simulation and treatment planning workflow solution. The companies said they plan on combining RaySearch’s advanced treatment planning system RayStation with GE Healthcare’s leading multi-modality (CT/MR/molecular imaging) simulator systems.
BridgeBio Pharma and Bristol Myers Squibb announced an exclusive license to develop and commercialize BBP-398, an SHP2 inhibitor, in oncology.
Cullinan Oncology Inc. and Taiho Pharmaceutical Co., Ltd. announced an agreement through which Taiho will acquire Cullinan Pearl Corp. and co-develop and co-commercialize Cullinan Oncology’s lead program, CLN-081/TAS6417, an orally available, differentiated, irreversible EGFR inhibitor that selectively targets cells expressing EGFR exon 20 insertion mutations, while sparing cells expressing wild-type EGFR in non-small cell lung cancer.