IQVIA Predictive Clinical Development Cuts Trial Delays With AI-Powered Approach
IQVIA has launched IQVIA Predictive Clinical Development, an AI-powered platform built with Anthropic, AWS, Databricks, Microsoft, NVIDIA, Palantir and Snowflake, designed to help sponsors bring new therapies to market up to two years faster.
AstraZeneca Secures Etcamah Breast Cancer Approval in Combination With CDK4/6 Inhibitors for US Patients
AstraZeneca’s Etcamah (camizestrant) has won US FDA approval alongside CDK4/6 inhibitors for HR-positive, HER2-negative breast cancer patients who develop an ESR1 mutation before disease progression.
AbbVie’s Etentamig Multiple Myeloma Trial Meets Both Primary Endpoints in Phase 3 CERVINO Study
AbbVie’s Phase 3 CERVINO trial shows etentamig, an investigational BCMA x CD3 bispecific, significantly improved response rate and progression-free survival versus standard therapies in relapsed/refractory multiple myeloma.
AstraZeneca’s Enhertu EU Approval: Enhertu Plus Pertuzumab Cleared as First-Line Therapy for HER2-Positive Metastatic Breast Cancer
The European Commission has approved Enhertu plus pertuzumab as a first-line treatment for HER2-positive metastatic breast cancer, marking AstraZeneca and Daiichi Sankyo’s first new EU regimen in this setting in over a decade, backed by DESTINY-Breast09 data showing a 44% reduction in progression or death risk.
Lilly Merida Biosciences Acquisition: Eli Lilly to Pay $2.875 Billion for Precision Autoantibody Therapies
Eli Lilly will pay up to $2.875 billion to acquire Merida Biosciences, gaining a precision antibody-degradation platform led by Phase 1 candidate MER511 for Graves’ disease and thyroid eye disease.
Roche Vabysmo PCV Study Shows Sustained Two-Year Results in Difficult-to-Treat nAMD Subtype
New two-year data from Roche’s Phase IIIb/IV SALWEEN trial show that Vabysmo (faricimab) delivers durable vision gains and disease control in Asian patients with polypoidal choroidal vasculopathy (PCV), a severe subtype of neovascular age-related macular degeneration, while cutting treatment visits for the majority of patients.
TEZSPIRE Eosinophilic Esophagitis Trial: Amgen, AstraZeneca Report Positive Phase 3 CROSSING Results
Amgen and AstraZeneca announced that TEZSPIRE (tezepelumab-ekko) achieved statistically significant and clinically meaningful results across both co-primary endpoints and all key secondary endpoints in the Phase 3 CROSSING trial in eosinophilic esophagitis, with benefits sustained through week 52.
Abbott Libre Duo 10 Day Wins FDA Authorization as World’s First Dual Glucose-Ketone Sensor
Abbott Libre Duo 10 Day has received FDA authorization as the world’s first dual glucose-ketone biowearable, designed to alert people with diabetes to rising DKA risk while tracking glucose in real time.
Johnson & Johnson’s IMAAVY Nipocalimab-aahu Wins FDA Approval as First-Ever Treatment for Warm Autoimmune Hemolytic Anemia
Johnson & Johnson’s IMAAVY nipocalimab-aahu has received FDA approval as the first-ever treatment for warm autoimmune hemolytic anemia (wAIHA), based on durable hemoglobin response data from the Phase 2/3 ENERGY study.
IQVIA Clinical Decision Support Tool Wins 2026 AI Breakthrough Award for Predictive Modeling Solution of the Year
IQVIA’s AI-enabled Clinical Decision Support Tool, built with Breakthrough T1D, won the 2026 AI Breakthrough Award for Predictive Modeling Solution of the Year after cutting T1D misdiagnosis screening workload by 99.5% and lifting diagnostic yield 127-fold.